Sleuthing Health and more

Sleuthing Health and more  

 Sleuthing Health, Deals, Tech & More July 24, 2016  

 Michele Skupp [email protected] 973‐369‐7490  

Here are my informal notes for your use only: July 24 2016

My Informal takeover notes with attributions *health in green, tech in purple, energy/basic in blue, retail in maroon, financials in orange, miscellaneous in black Jul 24 2016 HAIN as eventual takeover bait on Seeking Alpha Jul 24 2016 CRM Salesforce would have bid ‘much higher’ for LinkedIn, topping Microsoft’s $26.2B deal Marc Benioff doesn’t give up easily. The Salesforce CEO read LinkedIn’s account of its acquisition negotiations with Microsoft and Salesforce — filed with the SEC after Microsoft reached an agreement to acquire the business social network for more than $26 billion — and told LinkedIn’s Reid Hoffman and Jeff Weiner that Salesforce would have bid even more, if they had continued talking, article in Gee WIre. Jul 24 2016 LNKD CRM Salesforce would have bid ‘much higher’ for LNKD, topping Microsoft’s $26.2B deal Marc Benioff doesn’t give up easily. The Salesforce CEO read LinkedIn’s account of its acquisition negotiations with Microsoft and Salesforce — filed with the SEC after Microsoft reached an agreement to acquire the business social network for more than $26 billion — and told LinkedIn’s Reid Hoffman and Jeff Weiner that Salesforce would have bid even more, if they had continued talking, article in Geek Wire

Jul 24 2016 The action by the justice department signals that the health insurance market has become so concentrated it is unlikely that any further large scale deals can be done. “At least under this administration who knows what will happen if Trump is elected.” Article in the Guardian Jul 23 2016 HSY nearing settlement in regards to the Milton Hershey trust that would provide the clarity for MDLZ to make a new offer, article in the NY POST Jul 23 2016 MDLZ article that HSY is nearing settlement in regards to the Milton Hershey trust that would provide the clarity for MDLZ to make a new offer, article in the NY POST Jul 23 2016 Utilities industry discussed in Barron's, don’t expect the consolidation to end any time soon Jul 22 2016 Columbus Gold as takeover bait on Streetwise Reports Jul 22 2016 Integra Gold as takeover bait on Streetwise Reports Jul 22 2016 Southern Silver Exploration as takeover bait on Streetwise Reports Jul 22 2016 Fission Uranium as takeover bait on Streetwise Reports

Jul 22 2016 Replicel must receive positive trial results from its skin wrinkle and tendinosis trials. RepliCel then needs to attract another partner or search for a strategic alternative.If the

valuation doesn’t budge even after good clinical results, then we can see multiple scenarios. The company could simply die, it could be purchased, or even taken private, article on Biowatch News.

Jul 22 2016 SHPG as takeover bait for PFE pondered in Forbes

Jul 22 2016 PFE SHPG as potential takeover bait for PFE pondered in Forbes

Jul 22 2016 PTLA as takeover bait for PFE pondered in Forbes

Jul 22 2016 PFE PTLA as takeover bait for PFE pondered in Forbes

Jul 22 2016 REGN as takeover bait for SNY pondered in Forbes

Jul 22 2016 BIIB pondered as takeover/merger bait for SNY in Forbes

Jul 22 2016 SNY REGN as takeover bait for SNY pondered in Forbes

Jul 22 2016 SNY BIIB pondered as takeover/merger bait for SNY in Forbes

Jul 22 2016 GILD should target companies like TSRO says Guggenheim in a note

Jul 22 2016 TSRO GILD should target companies like TSRO says Guggenheim in a note

Jul 21 2016 BMRN and RHHBY coyness discussed in Betaville, a deal??

Jul 21 2016 ACAD: next highest probability buy out target within 2016. Disclosure: long ACAD on twtr

Jul 21 2016 RHHBY coyness in regards to BMRN buyout in Betaville

Jul 21 2016 GILD as takeover or merger of equal bait with MRK in Forbes

Jul 21 2016 MRK as takeover suitor or merger of equal partner for GILD in Forbes

Jul 21 2016 IONS as takeover bait for MRK in Forbes

Jul 21 2016 MRK as potential suitor for IONS in Forbes Jul 21 2016 P Pandora could wait and be worth more than the $ 15 LMCA supposed bid,discussed in Forbes

Jul 21 2016 LMCA P Pandora could wait and be worth more than the $ 15 LMCA supposed bid,discussed in Forbes

Jul 21 2016 BMRN news that RHHBY says that is unlikely to make a big acquisition in the near term.—and RHHBY CEO Severin Schwan declines to comment on speculation co. is interested in buying BioMarin at media event in Basel. RHHBY strategy remains to seek small, medium-sized deals Roche CEO: biotech valuations are too high even after recent market correction

Jul 21 2016 RHHBY says that is unlikely to make a big acquisition in the near term.—and RHHBY CEO Severin Schwan declines to comment on speculation co. is interested in buying BioMarin at media event in Basel. RHHBY strategy remains to seek small, medium-sized deals Roche CEO: biotech valuations are too high even after recent market correction Jul 21 2016 MON Is a White Knight poised to provide an “acceptable” offer for Monsanto (MON) and totally squelch Bayer AG’s (BAYN) unsolicited buyout bid? Rumors are swirling that Monsanto execs are talking with other interested parties to either sell a big stake or the entire

company to gain a higher price for its assets. Monsanto has said unequivocally that it was “exploring other strategic options.”article in Forbes

Jul 21 2016 Actelion continues looking for smaller deals:You should not expect any big deal soon, smaller deals maybe,” CEO Clozel says in phone interview Co. may seek “very early-stage” assets, “in specialized, very rare diseases, specialty products; innovative drugs are rare, we have to be wide in our search:” Clozel Problem with large transactions is risk, not only cost; “we are not competitive with large companies that have big patent cliffs to fill and are ready to pay much higher prices than us and to take bigger risks:” Clozel Co. has not been approached for a deal It’s “highly unlikely” that Actelion will get Tracleer generics in the U.S. before year-end, CFO Muller says, bberg story

Jul 21 2016 Otsuka the prime suitor. Remember they already have $75 million invested in Ariad and another $75 committed to invest (Japan and all of Asia is a big market for both Pon and Brig). Yesterday volume was not a fluke. Something is going on and it's about to be announced., blurb on Investor Hub

Jul 21 2016 ARIA Otsuka the prime suitor. Remember they already have $75 million invested in Ariad and another $75 committed to invest (Japan and all of Asia is a big market for both Pon and Brig). Yesterday volume was not a fluke. Something is going on and it's about to be announced, blurb on Investor Hub Jul 21 2016 AmTRAN as next target for LeEcoMedia?, rumors have been buzzing these last few days about rumors of a potential acquisition by online video superstar LeEco (of the struggling low-cost TV brand Vizio, owned by Taiwan’s AmTRAN Technology, article on YCBB Jul 21 2016 LeEcoMedia AmTRAN as next target for LeEcoMedia?, rumors have been buzzing these last few days about rumors of a potential acquisition by online video superstar LeEco (of the struggling low-cost TV brand Vizio, owned by Taiwan’s AmTRAN Technology, article on YCBB

Jul 21 2016 BIIB has been much stingier than many of its rivals in those areas. It did say on Thursday's call that it's looking aggressively for deals and to bolster the pipeline. It's past time.

Jul 21 2016 Failure of 2 health insurer mergers is unlikely to thwart more efforts, Other insurers could follow suit by buying a PBM , a chain of urgent care centers or something similar to what UNH Optum unit has done in their blockbuilding, article in NY Times Biz

New health events added to our work (there are a lot of them)

DATE EVENT Jul 23-28 2016 AVXL AT AAIC

Jul 24 2016 JNJ GLENMARK MUST ANSWER JNJ NEW SUIT OVER ITS CANCER DRUG ZYTIGA (SOURCE BBERG)BY

Jul 24-26 2016 NVO AT WFH Jul 24-28 2016 ALNY AND SNY AT WFHJul 24-28 2016 BAYER AT WFH Jul 24-28 2016 BIIB AND SOBI AT WFHJul 24-28 2016 BIOTEST AT WFHJul 24-28 2016 BMRN AT WFH

Jul 24 -28 2016 CSL BEHRING AT WFHJul 24-28 2016 GRFS AT WFH Jul 24 -28 2016 KEDRION BIOPHARMA AT WFHJul 24-28 2016 LFB AT WFH Jul 24-28 2016 OCTAPHARMA AT WFHJul 24-28 2016 QURE AMT -060 DATA AT WFHJul 24-28 2016 RHHBY AT WFH Jul 24-28 2016 SHPG BXLT AT WFHJul 24-28 2016 SNY AND ALNY DATA AT WFHJul 24 -28 2016 SOBI AND BIIB AT WFHJul 25 2016 NVS ROADSHOWJul 25 2016 NVS-BERENBERG- LONDONJul 26 2016 AXON - JEFFERIES-TORONTO, CANADAJul 26 2016 KDMN KADMON IPO DUEJul 26 2016 MNOV ANALYST MEETINGJul 26 2016 PTLA -MORGAN STANLEYJul 26 2016 RDY ANNUAL MEETINGJul 26 2016 TRVN- WEDBUSH

Jul 26 2016 WELLS FARGO BIOTECH ACCESS DAY ALNY BIIB BLUE MACK TSRO- BOSTON

Jul 27 2016 AEZS - MAXIM-NEW YORK, NYJul 27 2016 AEZS - MAXIM-NEW YORK, NYJul 27 2016 JNP ANNUAL MEETINGJul 27 2016 MCK ANNUAL MEETINGJul 27 2016 BMRN BMN 270 CONF CALL AT WFH Jul 28 2016 BIOV BIOVENTUS IPO DUEJul 28 2016 BVX ANNUAL MEETINGJul 28 2016 COCP ANNUAL MEETINGJul 28 2016 EXAS ANNUAL MEETINGJul 28 2016 GSK ANNUAL MEETING

Jul 28 2016 SAN FRANCISCO HEP C AND HEP B EVENT “ THINK ABOUT THE LINK , SHINING A LIGHT ON THE LINK BETWEEN VIRAL HEPATITIS AND LIVER CANCER

Jul 29 2016 ASTELLAS 1Q 2017 ANALYST MEETING

Jul 29 2016 CELG POSTPONED CASE SCHEDULING IN THE SUIT OVER ABRAXANE COPIES( SOURCE BBERG) TO

Jul 29 2016 DAIICHI SANKYO ANALYST MEETINGJul 29 2016 HOYA ANALYST MEETINGJul 29 2016 NVS ANNUAL MEETINGJul 31 2016 KYOWA HAKKO KIRIN ANALYST MEETING WEBCAST

Jul 31 2016 SPARTAN BIOSCIENCE WILL BE LAUNCHING THE CUBE AND AN INITIAL ASSAY MENU AT AACC

Jul 31- Aug 4 2016 A AT AACC

Jul 31- Aug 4 2016 ABT AT AACC Jul 31- Aug 4 2016 ALR AT AACC Jul 31- Aug 4 2016 ALXN AT AACC Jul 31- Aug 4 2016 BIO AT AACC Jul 31- Aug 4 2016 CEMI AT AACC Jul 31- Aug 4 2016 CPHD AT AACC Jul 31- Aug 4 2016 DGX AT AACC Jul 31- Aug 4 2016 GE AT AACC Jul 31- Aug 4 2016 GRFS AT AACC Jul 31- Aug 4 2016 HAE AT AACC Jul 31- Aug 4 2016 HIT AT AACC Jul 31- Aug 4 2016 HOLX AT AACC Jul 31- Aug 4 2016 IART AT AACC Jul 31- Aug 4 2016 LMNX AT AACC Jul 31- Aug 4 2016 NSPH AT AACC Jul 31- Aug 4 2016 OSUR AT AACC Jul 31- Aug 4 2016 PLXS AT AACC Jul 31- Aug 4 2016 QGEN AT AACC Jul 31- Aug 4 2016 QUANTERIX AT AACCJul 31- Aug 4 2016 RHHBY AT AACCJul 31- Aug 4 2016 SI AT AACC Jul 31- Aug 4 2016 SIAL AT AACC Jul 31- Aug 4 2016 SRDX AT AACC Jul 31- Aug 4 2016 TAIGEN AT AACCJul 31- Aug 4 2016 TECAN AT AACCJul 31- Aug 4 2016 TMO AT AACC Jul 31- Aug 4 2016 VIVO AT AACC Jul 31- Aug 4 2016 WAT AT AACC Jul 31- Aug 4 2016 ZBRA AT AACC Aug 1 2016 SHIONOGI ANALYST MEETINGAug 1 2016 UMN PHARM ANALYST MEETINGAug 1- 4 2016 AZN ROADSHOWAug 2 2016 EGRX ANNUAL MEETINGAug 2 2016 MITSUBISHI TANABE PHARMA ANALYST MEETINGAug 2 2016 PBH ANNUAL MEETINGAug 2 2016 SANTEN PHARMACEUTICAL ANALYST MEETINGAug 2 2016 STE ANNUAL MEETINGAug 2 2016 TTNP ANNUAL MEETING

Aug 3 2016

CENTER FOR STRATEGIC AND INTERNATIONAL STUDIES (CSIS) GLOBAL HEALTH POLICY CENTER AND KAISER FAMILY FOUNDATION WILL HOST A BRIEFING TO ASSESS THE MAJOR OUTCOMES OF THE 2016 INTERNATIONAL AIDS CONFERENCE (AIDS 2016), HELD FROM JULY 18-22 IN DURBAN, SOUTH AFRICA. THE DISCUSSION WILL TOUCH ON THE LATEST SCIENTIFIC ADVANCEMENTS, THE CURRENT FUNDING CLIMATE FOR HIV RESPONSE, AND OTHER DEVELOPMENTS AND CONTRIBUTIONS TO THE FIELD EMERGING FROM THE CONFERENCE PANELISTS WILL INCLUDE CHRIS BEYRER, PRESIDENT OF THE INTERNATIONAL AIDS SOCIETY; AMBASSADOR DEBORAH L. BIRX, THE U.S. GLOBAL AIDS COORDINATOR; AND JEN KATES, KAISER FAMILY FOUNDATION VICE PRESIDENT AND DIRECTOR OF GLOBAL HEALTH AND HIV POLICY. J. STEPHEN MORRISON, SENIOR VICE PRESIDENT AND DIRECTOR, GLOBAL HEALTH POLICY CENTER AT CSIS, WILL MODERATE THE PANEL DISCUSSION

Aug 3 2016 EISAI ANALYST MEETINGAug 3 2016 FLDM ANNUAL MEETINGAug 4 2016 JAZZ ANNUAL MEETINGAug 4 2016 TERUMO ANALYST MEETING

Aug 4 2016

VC ANGEL EVENT IN NYC WILL DISCUSS TERMS, VALUATIONS, THE NYC INVESTING LANDSCAPE, WHATS GETTING THE ATTENTION OF ANGELS & VCS, HOW CROWDFUNDING FITS IN AND MORE MODERATOR: DAVID SORIN, MCCARTER & ENGLISH MODERATOR: KEVIN PIANKO, WEISERMAZARS WELCOME ADDRESS: ALAN CUTTER, AC LION JAY LEVY, ZELKOVA VENTURES LAUREL TOUBY, FLATIRON INVESTORS DAVID GOLDBERG, CORIGIN VENTURES ROBERT HAYDEN, NY LIFE VENTURES CARYN EFFRON, ANGEL INVESTOR KATHERINE O'NEILL, JUMPSTART NJ ANGELS PETER WEISS, ARC ANGEL FUND RAVI PATEL, AUDIENCE VENTURES BEAU GORDON, STAGEFRONT PARTNERS 2PM - 6PM

Aug 7 2016 PLX ANNUAL MEETINGAug 8 2016 MEDICAL DATA VISION ANALYST MEETINGAug 10 2016 ABMD ANNUAL MEETINGAug 10 2016 ONCOLYS BIOPHARMA ANALYST MEETINGAug 11 2016 MEDIGENE AG ANNUAL MEETINGAug 11 2016 MOLOGEN ANNUAL MEETINGAug 11 2016 NAVB ANNUAL MEETINGAug 11 2016 RAQAULIA PHARMA ANALYST MEETING

Aug 11 2016 UNDERSTANDING LONG-TERM RESPONSE RATES AND TREATMENT DILEMMAS IN DIABETIC MACULAR EDEMA, SPONSORED BY EVOLVE MEDICAL – SAN FRAN

Aug 15 2016 EBIO SPECIAL MEETING

Aug 15 2016 PIP SIGA COURT HEARING TO CONSIDER THE JOINT MOTION IS SCHEDULED TO BE HELD BEFORE THE BANKRUPTCY COURT ON

Aug 15 2016 SIGA PIP COURT HEARING TO CONSIDER THE JOINT MOTION IS SCHEDULED TO BE HELD BEFORE THE BANKRUPTCY COURT ON

Aug 15-18 2016 MITSUBISHI UFJ SECURITIES TECHNOLOGY TOUR - SEATTLE - SEATTLE, WA

Aug 15-18 2016 MITSUBISHI UFJ SECURITIES TECHNOLOGY TOUR - SF - SAN FRANCISCO, CA

Aug 15-18 2016 MITSUBISHI UFJ SECURITIES TECHNOLOGY TOUR - SILICON VALLEY - CA

Aug 16 2016 LBIO ANNUAL MEETINGAug 16 2016 QSII ANNUAL MEETING

Aug 16-20 2016 38TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY (EMBC2016) LAKE BUENA VISTA- FLORIDA

Aug 16-20 2016 BGSM BIOSIG WILL PARTICIPATE AT THE 38TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY (EMBC2016)

Aug 17 2016

APDA EXPERT PERSPECTIVES ON HOW TO TAKE AN ACTIVE ROLE IN THE TREATMENT PLAN OF PEOPLE WITH PARKINSON’S DISEASE (PD). ASSISTANT PROFESSOR DEPARTMENT OF NEUROLOGYEMORY UNIVERSITY SCHOOL OF MEDICINE ATLANTA, GA HARRISON WALKER, MD ASSOCIATE PROFESSOR OF NEUROLOGY MEDICAL DIRECTOR FOR SURGICAL MOVEMENT DISORDERS UNIVERSITY OF ALABAMA AT BIRMINGHAM BIRMINGHAM, ALCO SPECIFIC EVENTS TO ADD NON HEALTH THIS PROGRAM IS DESIGNED TO HELP PEOPLE WITH PD, FAMILY MEMBERS AND CARE PARTNERS

Aug 17 2016 HEB ANNUAL MEETINGAug 17 2016 ONVO ANNUAL MEETINGAug 19 2016 LNKD MSFT SPECIAL SHAREHOLDERS MEETING ON MERGER Aug 19 2016 MSFT LNKD SPECIAL SHAREHOLDERS MEETING ON MERGER Aug 25 2016 ENZY ANNUAL MEETINGAug 26 2016 COLORADO LIFE SCIENCE INNOVATIONAug 26 2016 STADA ARZNEIMITTEL AG ANNUAL MEETINGAug 27-30 2016 ABIO AT ESC Aug 27-30 2016 ABT AT ESC Aug 27-30 2016 ACARIX AT ESC Aug 27-30 2016 ACTELION AT ESCAug 27-30 2016 AMGN AT ESC Aug 27-30 2016 AZN AT ESC Aug 27-30 2016 BAYER AT ESC Aug 27-30 2016 BI AT ESC Aug 27-30 2016 BMY AT ESC Aug 27-30 2016 CRME AT ESC Aug 27-30 2016 DAIICHI SANKYO AT ESCAug 27-30 2016 EW AT ESC Aug 27-30 2016 GSK AT ESC Aug 27-30 2016 HIT AT ESC Aug 27-30 2016 MDT AT ESC

Aug 27-30 2016 MRK AT ESC Aug 27-30 2016 NVS AT ESC Aug 27-30 2016 PHG AT ESC Aug 27-30 2016 PTLA AT ESC Aug 27-30 2016 RECORDATI AT ESCAug 27-30 2016 REGN AT ESC Aug 27-30 2016 RHHBY AT ESC Aug 27-30 2016 RMD AT ESC Aug 27-30 2016 SERVIER AT ESCAug 27-30 2016 SHPG AT ESC Aug 27-30 2016 SI AT ESC Aug 27-30 2016 SNY AT ESC Aug 27-30 2016 STJ AT ESC Aug 27-30 2016 TMO AT ESC Aug 27-30 2016 TOSHIBA AT ESCAug 27-30 2016 ZOLL AT ESC

Sep 1 2016 AMNEAL A DECISION ON WHETHER SHPG CAN AMEND ITS COMPLAINT AGAINST AMNEAL OVER LIALDA COPIES IS POSTPONED UNTIL (SOURCE BBERG)

Sep 1 2016 PARETO SECURITIES HEALTHCARE SEMINAR - STOCKHOLM, SE

Sep 1 2016 SHPG A DECISION ON WHETHER SHPG CAN AMEND ITS COMPLAINT AGAINST AMNEAL OVER LIALDA COPIES IS POSTPONED UNTIL (SOURCE BBERG)

Sep 3-7 2016 ACTELION AT ERSSep 3-7 2016 ADHERIUM AT ERSSep 3-7 2016 AZN AT ERS Sep 3-7 2016 BAYER AT ERS Sep 3-7 2016 BI AT ERS Sep 3-7 2016 BSX AT ERS Sep 3-7 2016 CEMP AT ERS Sep 3-7 2016 CHIESI AT ERS Sep 3-7 2016 CIPLA AT ERS Sep 3-7 2016 CSL AT ERS Sep 3-7 2016 DDD AT ERS Sep 3-7 2016 FUJIFILM AT ERSSep 3-7 2016 GRFS AT ERS Sep 3-7 2016 GSK AT ERS Sep 3-7 2016 HIT AT ERS Sep 3-7 2016 INSM AT ERS Sep 3-7 2016 MUNDIPHARMA AT ERSSep 3-7 2016 NVS AT ERS Sep 3-7 2016 OXFORD IMMUNOTECH AT ERSSep 3-7 2016 PFE AT ERS Sep 3-7 2016 PHG AT ERS

Sep 3-7 2016 PRXL AT ERS Sep 3-7 2016 Q AT ERS Sep 3-7 2016 QGEN AT ERS Sep 3-7 2016 REGN AT ERS Sep 3-7 2016 RMD AT ERS Sep 3-7 2016 SNY AT ERS Sep 3-7 2016 TAKEDA AT ERSSep 3-7 2016 TEVA AT ERS Sep 3-7 2016 UTHR AT ERS Sep 3-7 2016 ZAMBON AT ERS

Sep 6 2016 BARCLAYS SELECT EUROPEAN MEDIA AND TELECOM FORUM - LONDON, GB

Sep 8 2016 BARCLAYS DISRUPTIVE MOBILITY CONFERENCE - LONDON, GB Sep 8 2016 UBS SWISS DAY - PARIS, FRSep 14 2016 MAXIM GROUP INAUGURAL ISRAEL DAY - NEW YORK, NY Sep 15 2016 SYT CHEM CHINA ACCC DECISION DUESep 21 2016 ARIZONA BIO AWARDSSep 21-22 2016 AZ BIO WHITEHAT INVESTORS-PHOENIX , AZ

Sep 22-24 2016

AGBT PRECISION HEALTH CONFERENCE UNITES THE WORLD’S LEADING CLINICAL TRANSLATION PROFESSIONALS FOR THREE DAYS OF KEYNOTE TALKS AND INDUSTRY INSIGHTS.BUILDS UPON THE SUCCESSFUL MODEL DEFINED BY THE ANNUAL AGBT’S MEETING, RECOGNIZED WORLDWIDE AS THE LEADING GENOMIC TECHNOLOGY RESEARCH CONFERENCE DIANA BIANCHI, TUFTS MEDICAL CENTER STEPHEN KINGSMORE, RADY CHILDREN’S HOSPITAL HEIDI REHM, HARVARD MEDICAL SCHOOL RICHARD DALY, DNANEXUS WILLIAM GAHL, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, NATIONAL INSTITUTES OF HEALTH MIA LEVY, VANDERBILT-INGRAM CANCER CENTER AMY MCGUIRE, BAYLOR COLLEGE OF MEDICINE NICKOLAS PAPADOPOULOS, JOHNS HOPKINS SCHOOL OF MEDICINE KENNA MILLS SHAW, MD ANDERSON CANCER CENTER ALAN SHULDINER, REGENERON GENETICS CENTER HOWARD JACOB, HUDSONALPHA IMRAN HAQUE, COUNSYL PRE-CONFERENCE TOPICS INCLUDE: NGS 101 NGS DATA ANALYSIS CHALLENGES OF NGS DATA INTERPRETATIONS NGS APPLICATIONS LECTURES AND ROUNDTABLES SCOTTSDALE, ARIZONA

Sep 23 2016 ONO PHARMACEUTICAL CO LTD R&D PRESENTATION Sep 23 2016 QGEN QIAGEN NV PRIVATE INVESTOR DAY

Sep 27 2016 GOLDMAN SACHS LEVERAGED FINANCE CONFERENCE - LONDON, GB

Sep 27 2016 UDG HEALTHCARE PLC CAPITAL MARKETS DAYSep 27 2016 WDAY WORKDAY INC ANALYST

Sep 27-28 2016 SACHS ASSOCIATES 16TH ANNUAL BIOTECH GLOBAL PARTNERING CONF- SWITZERLAND

Sep 27-29 2016 REIMBURSEMENT 101-201 WASHINGTON DCSep 28 2016 BLOOMBERG MOST INFLUENTIAL SUMMIT

Sep 28 2016 WEARABLES DEVICES WEBINAR REGULATORY AND LITIGATION

Sep 28-29 2016 LEERINK PARTNERS RARE DISEASE & IO ROUNDTABLE SERIES - NEW YORK, NY

Sep 29 2016 NORTH CAROLINA BIO ANNUAL MEETING

Oct 6 2016 WSJ GLOBAL FOOD FORUM- NYC MON CPB PNRA INGR, SPEAKERS INCLUDE MICHAEL J FRANK OF MON, DENISE MORRISON OF CPB, RONALD SCHAICH OF PNRA AND OTHERS- NYC

Oct 10 2016 INCY UPDATED DATA FROM THE PHASE 1 PORTION OF THE ECHO-202/KEYNOTE-037 TRIAL HAS BEEN ACCEPTED FOR A POSTER DISCUSSION AT THE ESMO

Oct 17 2016 SEETHRUEQUITY INVESTOR CONFERENCE - NEW YORK, NY

Oct 23 2016 MRK BLA FOR BEZLOTOXUMAB PDUFA DATE IS EXTENDED FROM JUL 23 2016 TO

Oct 25-27 2016

ARMH ARM TECHCON A RECORD 4,500 ATTENDEES—INCLUDING HARDWARE DESIGN ENGINEERS, SOFTWARE DEVELOPERS, SYSTEM ARCHITECTS, AND MANY MORE—WILL UNITE AT THE LEADING EVENT FOR TECHNOLOGY, TRAINING, AND NETWORKING IN ARM-BASED EMBEDDED SYSTEMS.– SANTA CLARA

Oct 27-29 2016 PRQR TOP-LINE DATA FROM THE 16 PATIENTS IN STUDY PQ-010-002 IS EXPECTED TO BE PRESENTED DURING THE NACFC

Oct 31- Nov 1 2016 510K SUBMISSIONS WORKSHOP – WASHINGTON DCNov 1-2 2016 KR THE KROGER CO INVESTOR CONFERENCENov 4 2016 PHG KONINKLIJKE PHILIPS NV CAPITAL MARKETS DAY Nov 7 2016 BIONOMICS LTD BNO.AX AND MERCK MRK ANNUAL SYMPOSIUM Nov 7 2016 MRK AND BIONOMICS LTD BNO.AX ANNUAL SYMPOSIUM

Nov 7 2016 SANFORD C BERNSTEIN TECHNOLOGY INNOVATION SUMMIT - NEW YORK, NY

Nov 9 2016 HOULIHAN LOKEY ALTERNATIVE ASSET VALUATION SYMPOSIUM - NEW YORK, NY

Nov 10 2016 ERIC LM ERICSSON CAPITAL MARKETS DAYNov 10 2016 SHPG INVESTOR DAY

Nov 10-11 2016 7TH ANNUAL ADVERTISING AND PROMOTION OF MEDICAL DEVICES CONF- WASH DC

Nov 15 2016 BRYAN GARNIER EUROPEAN HEALTHCARE CONFERENCE - PARIS, FR

Nov 15 2016 NOKIA NOKIA CORP CAPITAL MARKETS DAYNov 15-16 2016 MORGAN STANLEY EUROPEAN TMT CONFERENCE - BARCELONA, ESNov 16 2016 CYBERSECURITY SUMMIT – WASH DCNov 16 2016 LRCX LAM RESEARCH CORP INVESTOR AND ANALYST MEETING Nov 22 2016 NATIXIS MIDCAP CONFERENCE - PARIS, FRNov 28 2016 SNY SANOFI SA INDIVIDUAL SHAREHOLDERS MEETING – TOURS

Nov 29 2016 CITI ASEAN STARS OF THE NEXT DECADE: MULTI-SECTOR CHAMPIONS - HK - HK, HK

Nov 29 2016 EXANE MIDCAP FORUM - LONDON, GB

Nov 30 2016 UNITED MEDICAL SYSTEMS INTERNATIONAL AG UMS.FUMS ANALYST CONFERENCE 2016/2017

Dec 5 2016 JCI JOHNSON CONTROLS INC CORPORATE ANALYST MEETING

Dec 6 2016 DEO DIAGEO PLC BRUNCHTIME CALL WITH THE PRESIDENTS: NORTH AMERICA

Dec 8 2016 L'OREAL SA INDIVIDUAL SHAREHOLDERS MEETING – TOULOUSE Dec 8 2016 SNY SANOFI INDIVIDUAL SHAREHOLDERS MEETING – REIMS Dec 15 2016 CNC CENTENE CORP 2017 FINANCIAL GUIDANCE AND INVESTOR DAYJan 4 2017 LLY GUIDANCE CALLFeb 1-3 2017 IMMUNO-ONCOLOGY 36- NY NYFeb 6-7 2017 PATIENTS AS PARTNERS EUROPE- LONDONFeb 8-9 2017 DPHARM EUROPE- LONDONFeb 22-23 2017 EVIDENCE EUROPE 2017- LONDONFeb 22-23 2017 PHARMA PRICING AND MARKET ACCESS EUROPE 2017- LONDON Mar 2-3 2017 PATIENTS AS PARTNERS – PHILADELPHIAMar 8-9 2017 CLINICAL OUTSOURCING & PARTNERING WORLD EUROPE – LONDONMar 9-10 2017 R&D LEADERSHIP SUMMIT – MANALAPAN FLORIDA

Mar 14-17 2017 EYE FOR PHARMA – ALMIRALL JNJ LEO MRK SNY TEVA NVS VIIV BARCELONA

Apr 3-4 2017 CLINICAL TRIAL COLLABORATIONS – BOSTONApr 19-20 2017 WORLD DRUG SAFETY AMERICAS 2017 – CHICAGOApr 20-21 2017 SPANISH HEMATOLOGY MEETINGMay 7-9 2017 ICNC 2017 NUCLEAR CARDIOLOGY CONF – VIENNAMay 9-10 2017 DIGITAL PATH 2017- LONDONMay 10-11 2017 CHIEF MEDICAL OFFICER EASTJun 18-21 2017 EHRA EUROPACE CARDIOLOGY CONF -VIENNAJun 28-29 2017 RATIONAL COMBINATIONS 360 – NY NY

Jul 21 2017

PBYI POSSIBLE PDUFA DATE FOR PB272 (NERATINIB) FOR THE EXTENDED ADJUVANT TREATMENT OF PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER WHO HAVE RECEIVED PRIOR ADJUVANT TRASTUZUMAB (HERCEPTIN)-BASED THERAPY PDUFA COULD BE IN ONE YEAR

Jul 24 2017

AMGN UCB POSSIBLE BLA DATE FOR ROMOSOZUMAB, A TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AT INCREASED RISK OF FRACTURE( NEWS ON SUBMISSION JUL 22 2016) POSSIBLE BLA DATE

Jul 24 2017

UCB AMGN POSSIBLE BLA DATE FOR ROMOSOZUMAB, A TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AT INCREASED RISK OF FRACTURE( NEWS ON SUBMISSION JUL 22 2016) POSSIBLE BLA DATE

Aug 26-30 2017 EUROPEAN SOCIETY CARDIOLOGY ESC 2017 –BARCELONA

Biowatch news on BMRN Jul 27 event at WFH BMRN BioMarin's Treatment Results for Hemophilia A are Coming!

On July 27, 2016, BMRN investigators will be presenting extended data on its gene therapy (BMN-270) for hemophilia A at the World Federation of Hemophilia (WFH) Congress We should see the results from 9 patients who have been treated with BMN-270 for over 16 weeks.In April 2016, BioMarin reported strong proof of concept for its Phase I/II trial. While we were duly impressed, we also wanted to see evidence of durability. …we’ll be a lot less nervous after longer-term persistence and (free of) immunogenicity (with repeat dosing) are firmly established. Investors and Analysts will also be watching for safety, especially in the form of ALT levels, which signal organ stress. At 4:05pm ET, Wednesday, July 27, 2016, BioMarin will hold a presentation and conference call on the results. The company will be distributing the accompanying presentation slides at their website. The Magnificent 4 Vimizim :BioMarin has identified over 1,900 patients and looks for a total serviceable market of 3,000 patients. This translates to $650 to $800M in annualized sales within the next couple years or so. Pegyaliase: Top-line efficacy and neurocognitive results in 2H-2016. Will we see positive neurocognitive results? BMN-190 FDA recognizes desperate unfilled need to treat Batten disease and BioMarin is filing on the basis of the single Phase I/II trial. Management has (unsurprisingly) found a larger market than the original estimate of 500 patients, perhaps 1,500. BMN-111Vosoritide The recently announced results are very encouraging. BioMarin is currently testing a higher dose cohort and intends to launch a pivotal trial at the end of 2016. We expect substantive updates in 2H-2016. BioMarin Management believes that the 15 µg/kg dose is sufficient for a pivotal trial. The 30 µg/kg dose is being tested as a “catch-up” dose. For better or worse, the BMN-270 results should impact BioMarin’s valuation. With positive results, we will include BMN-270 into The Magnificent 5. It's a big deal. It doesn’t have to cure hemophilia; it will be successful if it reduces the disease severity. For example, it BMN-270 transforms severe cases into mild cases, and mild cases into almost normal, then it’s still a big success. The (current) Magnificent 4 are mid-stage to recently approved products that should double BioMarin’s revenues and usher solid profitability. It then becomes a strong takeover target. We expect one or two products to underperform or to be withdrawn…and it will still have a strong impact. The expected market size for a successful treatment for hemophilia A is over $1B. Given the need for treating hemophilia, continuing positive results should enable BMN-270 to have an expeditious development path. Stay tuned. As for the rest of its pipeline, we're unsure whether BioMarin is being given proper respect for BMN-190 and BMN-111. If successful, these have good market dynamics. The market pull for BMN-190 should be strong. The ongoing results are very good and we expect BMN-111 to receive an early approval from the FDA and EMA.

Biocentury weekend edition on biosimiliars

Feature article on biosimiliars on AMGN who is making biosimiliar Humira ABP501 (ABBV), and NVS Sandoz who is making biosimilar Enbrel GP2015 (AMGN) The article discusses that there are 16 biosimilars of Humira: Zydus Cadila which is marketed in India, plans to launch 2019, Reliance Life Sciences/Torrent Pharmaceuticals marketed in India, AMGN Daiichi Sankyo registration in US EU, Samsung/BIIB/MRK registration in EU, CHRS which is in PH III due to submit in US 2016 and EU 2017, Biocon/MYL PH III submit in US EU 2016, Biocad CJSC in PH III due to submit in emerging markets 2018 and in EU 2019, BI in PH III, Kyowa Hakko Kirin/Fujilfim PH III, LG Life Sciences/Mochida Pharmaceutical PH III, MRK-KG in PH III, MNTA SHPG in PH III, NVS in PH III, PFE in PH III, Oncobiologics/VPRO, Zhejiang will start PH III in the 2nd half of 2016, Walvax BIOCND in PH I The article Enbrel biosimilars, at least nine programs made it to the clinic with biosimilars of autoimmune drug Enbrel etancercept from AMGN . While the GP2015 BLA form NVS Sandoz is first to be reviewed by FDA, at least four are on the market outside the US Stage of development and any disclosed regulatory submission are shown below. 3S Bio/Cipla is marketed in China, India, Samsung/BIIB/MRK marketed in EU and South Korea, Hanwha Chemical marketed in South Korea, Intas Pharmaceutical marketed marketed in India, NVS registration in Taiwan, Mycenax/TSH Biopharm registration in Taiwan, CHRS Daiichi Sankyo SHPG in PH III submitted in EU, Japan 2016, LG Life Sciences/Mochida Pharmaceutical in PH III, Lupin/Yoshindo in PH III ABBV IP strategy will be effective in blocking most competitors, who predicted about 75% of the biosimilar versions of Humira under development will fail the IP tests. CHRS should have clear shot to launch in mid 2018. CHRS is also developing a biosimilar Enbrel for the European market, it plans to file an MAA this half. CHRS started developing an IP strategy for Humira five years ago, including plans to invalidate some ABBV patents and creating its own formulation. The USPTO Has awarded the company on adalimumab formulation patent and two are pending. CHRS intends to license its Humira and Enbrel biosimilars to a company that has the marketing muscle required to persuade physicians and patients and patients who are stable on an anti -TNF biologic to switch to a biosimilar. CHRS will announce a strategic deal for Humira in the first half of 2017, it is a better market for a larger company with a bigger sales force ABBV and AMGN can be expected to deploy a variety of weapons to avoid the calamitous loss in market share that typically accompanies expiration of small molecule patents. ABBV and other manufacturer of original biologics can fend off competition by providing rebates that reduces incentives to switch, according to Roger Longman

Other Biocentury articles Cell Medica plans to combine a CAR NKT platform from Baylor with Delenex scFV platform to treat solid tumors that they think is better than CART . Baylor is responsible for preclinical and PH I studies and Cell Medica will conduct PH II and PH III trials and fund preclinical and clin development. Cell Medica plans to develop CAR NKT therapies for neuroblastoma, SCLC, HCC and TNBC. It will take six months to identify antigen targeting sc Fvs and additional 6-12 months to optimize each fragment for a CAR construct. Cell Medica hope to bring 3-4 CAR therapies into the clinic in 2018. Cell Medica plans to use the Delenex technology to develop next generation CAR NKT and CART cells that could serve as local checkpoint inhibitors to counter immunosuppressive effects of the tumor microenvironment . Cell Medica plans to out license Delenex clinical and preprograms for further development. Delenex two most and compounds

are a topical formulation of DLX105, an anti TNF mAB fragment that has completed PH II studies in psoriasis IV formulation of DLX105 which has completed PH II test psoriasis in Bechet’s disease. VRX Brodalumab may become a medication of last resort in psoriasis, whatever brodalumab it will likely be squeezed by an upcoming wave of biologics that treat psoriasis by targeting IL 23 which could be available within a few years. Alexo Therapeutics is developing variant of signal regulatory protein alpha that antagonize CD47 to increase macrophage phagocytosis induced by anticancer antibodies ALX148 is slated to enter PH I testing next year, the PH I will evaluate ALX148 for safety as a single agent in patients with advanced solid tumors and hematologic malignancies for whom no treatment options are available

Geek Wire CRM Salesforce would have bid ‘much higher’ for LinkedIn, topping Microsoft’s $26.2B deal Marc Benioff doesn’t give up easily. The Salesforce CEO read LinkedIn’s account of its acquisition negotiations with Microsoft and Salesforce — filed with the SEC after Microsoft reached an agreement to acquire the business social network for more than $26 billion — and told LinkedIn’s Reid Hoffman and Jeff Weiner that Salesforce would have bid even more, if they had continued talking. That’s according to a new regulatory filing by LinkedIn, which describes a recent email to Hoffmann and Weiner from the CEO of “Party A,” widely reported to be Salesforce. The new filing explains, “Reflecting on the additional proposals it made after LinkedIn and Microsoft agreed to exclusivity, the email indicated that Party A would have bid much higher and made changes to the stock/cash components of its offers, but it was acting without communications from LinkedIn.” [T]he email indicated that Party A would have bid much higher and made changes to the stock/cash components of its offers, but it was acting without communications from LinkedIn. Here’s what happened, according to regulatory filings: LinkedIn received “best and final” offers from Microsoft and Salesforce on May 13. Microsoft offered $182/share in cash, and Salesforce offered the same amount in cash and stock. At that point, LinkedIn decided to negotiate solely with Microsoft, and informed Salesforce that it was entering into exclusive talks with another company. Undaunted by those exclusive negotiations, Salesforce revised its proposal on May 20 to the equivalent of $188/share in cash and stock. LinkedIn decided not to respond to that proposal, given its exclusivity agreement with Microsoft. Pressing his case, Benioff wrote to Hoffman and Weiner on May 25, pointing out that an increase in Salesforce’s share price had pushed the value of its offer even higher. LinkedIn reached an agreement on June 11 to be acquired by Microsoft for $196/share in cash, or $26.2 billion, the largest deal in the Redmond company’s history. A few weeks later, on July 1, LinkedIn’s regulatory filing provided new details about the previously private negotiations. And that’s what prompted Benioff to send his latest email to Hoffman and Weiner, telling them they could have done even better if they had kept talking. The continued lobbying by Benioff is notable in part because Microsoft and LinkedIn haven’t completed their transaction yet. Under terms of the acquisition agreement,

LinkedIn would need to pay Microsoft a $725 million termination fee if it accepts an “unsolicited superior proposal” from another company. However, Benioff didn’t receive an official response from LinkedIn to his latest email, either. According to the filing, a LinkedIn board committee “considered the contractual provisions contained in the definitive merger agreement with Microsoft, including those relating to discussions with third parties, and determined not to respond.”

Health news Aurobindo Pharma Ltd is planning to raise funds via a share sale to fund the acquisition of Teva's European assets -- if its bid is accepted by this month.The company is in race with two other multinationals for the acquisition which, if complemented, would put the company on the big league. Good profits and almost doubling of its market value has given the company a confidence booster for the acquisition that may cost it as high as $1.3 billion.For the promoters of Aurobindo Pharma, it may become a bit difficult to keep their characteristic low profile intact towards the end of this month if they win the race article in Business Standard AVXL announced data from the first of two posters at the Alzheimer’s Association International Conference® (AAIC) 2016.Data presented in the first poster highlights the evaluation of a maximum tolerated dose (MTD) of ANAVEX 2-73 as primary endpoint of the Phase 2a study in mild-to-moderate Alzheimer’s patients, as well as additional clinical safety data and positive unexpected therapeutic response events, such as improved mood, improved social engagement and increased independent activities through 31 weeks. The second poster will present efficacy data through 31 weeks“ANAVEX 2-73 data presented today is prerequisite information in order to progress into Phase 2/3 placebo controlled studies,” said Professor Harald Hampel, MD, PhD, Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC), Paris, France and member of Anavex’s Scientific Advisory Board. “ANAVEX 2-73’s specific molecular biology, combined with its observed favorable safety and tolerability profile makes it a very interesting candidate to explore in further clinical trials of different neurological diseases.” CLLS takes unique approach to Car-T therapy - The Financial Times writes that Pfizer-backed (PFE) Cellectis is taking a different approach in its pursuit of Car-T therapies, by harvesting cells from healthy donors rather than using a patient's own cells. If the approach works, the company could manufacture an "off-the-shelf" product that would be significantly cheaper than treatments pursued by Juno (JUNO), Novartis (NVS), and Kite (KITE). Cellectis recently began a clinical trial of Ucart19, and believes the treatment could be on the market in five years, article in FT. Cell Medica plans to combine a CAR NKT platform from Baylor with Delenex scFV platform to treat solid tumors that they think is better than CART . Baylor is responsible for preclinical and PH I studies and Cell Medica will conduct PH II and PH III trials and fund preclinical and clin development. Cell Medica plans to develop CAR NKT therapies for neuroblastoma, SCLC, HCC and TNBC. It will take six months to identify antigen targeting sc Fvs and additional 6-12 months to optimize each fragment for a CAR construct. Cell Medica hope to bring 3-4 CAR therapies into the clinic in 2018. Cell Medica plans to use the Delenex technology to develop next generation CAR NKT and CART cells that could serve as local checkpoint inhibitors to counter immunosuppressive effects of the tumor microenvironment . Cell Medica plans to out license Delenex clinical and preprograms for further development. Delenex two most and compounds are a topical formulation of DLX105, an anti TNF mAB fragment that has completed PH II

studies in psoriasis IV formulation of DLX105 which has completed PH II test psoriasis in Bechet’s disease article in Bioworld. DNA Biomedical Solutions Ltd. (TASE: DNA) news that their subsidiary Entera Bio raised $7.5 million in a loan convertible into shares. Pontifax led the round, with participation from private investors, many of whom are identified with immunotherapy company Kite Pharma: founder and CEO Arie Belldegrun (a director in Teva, director and TPG founding partner David Bonderman, and director and Two River cofounder and managing director Joshua Kazam. Following the announcement, DNA owns 51% of Entera Bio.Entera Bio is developing orally administered drugs as a replacement for injectables and IVs. Its leading drug is a product for the treatment of hypoparathyroidism (not to be confused with hypothyroidism) - an orphan disease that can result from an operation, tumor, or degenerative brain disease. It affects the level of calcium in the body, and in particular prevents recovery from a lack of calcium. It can be treated with Vitamin D or calcium, but these treatments have side effects.Entera Bio believes that the material it previously began to develop as an orally administered drug for treatment of osteoporosis can also be effective in treating the results of hypoparathyroidism. The company's drug, PTH, is based on an existing drug for treatment of osteoporosis, but with addition of Entera Bio's technology, which makes it possible to take the drug orally. Entera Bio hopes to begin Phase III trials for PTH soon, after the product was tested in Phase II trials. The payments on DNA Biomedical bonds in the coming year total $8.1 million, so it appears that the company will do everything it can to enhance the value of Entera Bio quickly. DNA Biomedical had $4.9 million in cash as of the end of March 2016, and has three other subsidiaries (article in the Globes) Entera Bio,a subsidiary of DNA Biomedical Solutions Ltd. (TASE: DNA), has raised $7.5 million in a loan convertible into shares. Pontifax led the round, with participation from private investors, many of whom are identified with immunotherapy company Kite Pharma: founder and CEO Arie Belldegrun (a director in Teva, director and TPG founding partner David Bonderman, and director and Two River cofounder and managing director Joshua Kazam. Following the announcement, DNA owns 51% of Entera Bio.Entera Bio is developing orally administered drugs as a replacement for injectables and IVs. Its leading drug is a product for the treatment of hypoparathyroidism (not to be confused with hypothyroidism) - an orphan disease that can result from an operation, tumor, or degenerative brain disease. It affects the level of calcium in the body, and in particular prevents recovery from a lack of calcium. It can be treated with Vitamin D or calcium, but these treatments have side effects.Entera Bio believes that the material it previously began to develop as an orally administered drug for treatment of osteoporosis can also be effective in treating the results of hypoparathyroidism. The company's drug, PTH, is based on an existing drug for treatment of osteoporosis, but with addition of Entera Bio's technology, which makes it possible to take the drug orally. Entera Bio hopes to begin Phase III trials for PTH soon, after the product was tested in Phase II trials. The current controlling shareholders in DNA Biomedical are Zeev Bronfeld (15.5% - Bronfeld and Pontifax were previously partners in the Biomedix Incubator and its subsidiaries); Oramed (Nasdaq: ORMD), from which some of the company's technology was purchased (8.7%); private investor Menahem Raphael (6%); DNA Biomedical CEO Yehonatan Malca (5.8%), and Excellence (5.3%).The payments on DNA Biomedical bonds in the coming year total $8.1 million, so it appears that the company will do everything it can to enhance the value of Entera Bio quickly.

DNA Biomedical had $4.9 million in cash as of the end of March 2016, and has three other subsidiaries.(article in the Globes) JUNO clinical trial deaths raise fears over gene therapy The Financial Times notes that the recent deaths in one Juno Therapeutics' Phase II "ROCKET" clinical trial of JCAR015, one of its Car-T product candidates, are raising fears that a treatment for blood cancers is being brought to market too quickly. TEVA Aurobindo Pharma plans share sale to fund Teva UK acquisition -- Business Standard Aurobindo is planning to raise funds via a share sale to fund the acquisition of Teva's European business, if its bid is accepted by this month. The acquisition could cost as high as $1.3B, according to the article.

Atlantic Live events to add: Atlantic LiveWashington Ideas Week – Sep 26-29 2016 Atlantic LIVE What’s Next- Chicago Oct 4-5 2016

Opal events to add Chief Nursing Officer Summit Dallas Sep 14-15 2016 Opal Medical Devices Summit- Scottsdale Jan 9- 10 2017 Public Funds Summit 2017- Scottsdale Jan 9-11 2017

Geek Wire events to add Geekwire Summit winter- Seattle Oct 4-5 2016

The Guardian on AET CI ANTM HUM news AET and HUM argue that the combination of the two companies would be more “efficient and effective”, which would decrease cost for members. The two companies said in a joint statement that they have “plans to vigorously defend the companies’ pending merger”. Anthem is challenging the justice department’s understanding of the insurance market, putting out a statement saying that “the DoJ’s action is based on a flawed analysis and misunderstanding of the dynamic, competitive and highly regulated healthcare landscape and is inconsistent with the way that the DoJ has reviewed past healthcare transactions.” Cigna for its part has taken a more muted tone, advising investors the deal is no longer projected to close this year, “if at all”. Overturning the ruling on appeal will be difficult,. During antitrust merger reviews, companies work to identify potential divestitures in areas of problematic overlap as a compromise. While Anthem has said it “will remain receptive to any efforts to reach a settlement with the DoJ that will allow us to complete the transaction,” neither of the two proposed mergers were able to provide enough divestitures to satisfy regulators. One issue with divestitures is finding buyers that would not be problematic in such a consolidated market, explained Spigel. Allowing the two mergers to go forward would also make it more difficult for new insurers to enter a market, further hindering future competition The decision by the justice department comes at a time when it has signaled that it will take a tougher stance on antitrust concerns, says Jeffrey Spiegel, head of the Antitrust Practice Group at King & Spalding. The action by the justice department signals that the health insurance market has become so concentrated it is unlikely that any further large scale deals can be done. “At least under this administration,” says Spiegel, adding with a laugh, “who knows what will happen if Trump is elected.”

Seeking Alpha stories

GILD Sell Gilead Into Earnings Shock Exchange XOMA Buy XOMA Corporation For Its Monoclonal Antibodies To Treat Congenital Hyperinsulinism And Refractory Prolactinoma Bhavneesh Sharma PTHN Patheon - Avoiding This IPO On The Back Of Valuation And Leverage The Value Investor CXRX Concordia International Is A Sewer Canuck Investments

The Business Standard on Aurobindo gets ready to play with the big boys Aurobindo Pharmaceuticals is planning to raise funds via a share sale to fund the acquisition of Israel-based Teva Pharmaceutical’s European assets, if its bid is accepted by this month. The company is in a race with two other multinationals for the acquisition. Good profits and a near-doubling of its market value has given the company a confidence booster for the acquisition. Which could cost it as much as $1.3 billion (Rs 8,700 crore). For the promoters of Aurobindo, it might become a bit difficult to keep their characteristic low profile intact towards the end of this month if they win the race. To prepare the ground, the board of directors had cleared its proposal to raise $600 million (Rs 4,000 crore), to fund growth and also use a portion of it for retiring some debt. There are five-six contenders in the fray. By the end of this month, we might get to know which way the deal would go,” a top company official told Business Standard, on condition of anonymity. VYING FOR ACQUISITION : TEVA offer to sell products in Europe comes in handy for Aurobindo Pharma to pursue an aggressive growth strategy , Aurobindo is already creating capacities targeting the European market, thanks to the Actavis' product portfolio Aurobindo became fourth largest Indian generic drugmaker beating some of the big companies in terms of new launches Company sets itself a $3 bn revenue target by 2017-18, from around $ 2 bn in FY16 Teva’s product deal is estimated at 1.3 bn at the lower end, little over 50 per cent of Aurobindo’s revenues in 2015-16 TEVA offer to divest overlapping assets in the UK, Ireland and Iceland — a precondition for acquisition of Allergan Plc's generics business, put by the European authorities — comes as Aurobindo’s oral solid finished dosage facility at Naidupet in Andhra Pradesh was getting ready for commissioning. The facility was being exclusively set up to make products acquired from Actavis, as the company seeks to shift the manufacturing to the lower cost Indian base. “The company might see an upside of Rs 500 crore in top line once the Naidupet facility begins operations in the next three-four months,” sources said. On top of the business anticipated from this facility, the spare capacity here and at other units are another reason to bid for Teva’s products. Till date, Aurobindo was happy with small-sized acquisitions. The value of its largest one so far was $132.5 mn, an auction sale of US-based nutraceutical Natrol, a year before.In January 2014, it had paid €30 million (Rs 250 crore) for the loss-making commercial operations in seven western European countries from Irish pharma company Actavis Plc. It was able to quickly this entity around, creating the conditions to think of a big deal. The Actavis step had put Aurobindo among the top 10 in Europe — it acquired personnel, commercial infrastructure, products, marketing authorisation and dossier licence rights in seven countries. Both have also entered into long-term commercial and supply arrangements. Europe is the second biggest market for Aurobindo, accounting for 28 per cent of its global formulations business.Aurobindo last year said it was spending Rs 900 crore on capacity addition — it plans to make India a key sourcing

hub for its western European generics drug business. Besides at Naidupet, the company is setting up a finished dosage facility for European markets at Visakhapatnam in Andhra.P V Ramaprasad Reddy and wife P Suneela Rani together hold 70 per cent of the promoter's and promoter group’s share-holding in the company. Currently Aurobindo is the fourth-largest Indian generic pharmaceutical company. “Aurobindo and Lupin are two companies where promoters provide direction and guidance, while letting professional managers run company affairs,”a senior industry professional said about Reddy, who is also known for a reluctance to come on a public dais. He was executive chairman till December 2012. Then, he reduced his position to non-executive director, after shifting base to the US, to focus on the growth of Aurobindo’s US business. “Aurobindo Pharma has scripted an impressive turnaround post end-FY12, underpinned by its superior execution. The company has stayed compliant with US (regulator’s) evolving norms, overcome constraints of a basic generics portfolio and grown FY12-16 US sales at a 40 per cent compounded annual rate (CAGR) to $940m in FY16,” went a report issued on Saturday by IDFC Securities. The key growth drivers are sustained momentum in US sales and turnaround in Europe operations, with reduction in capex intensity from FY18. We anticipate an impressive 20 per cent earnings CAGR and Rs 15 billion free cash generation over FY16-18E,” went a report issued on Saturday by IDFC Securities.

July 23 2016

New events to add San Francisco Hep C and Hep B event “ think about the link , shining a light on the link between viral hepatitis and Liver cancer Jul 28 2016 LNKD MSFT special shareholders meeting on merger Aug 19 2016 MSFT LNKD special shareholders meeting on merger Aug 19 2016 BGSM BioSig will participate at the 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC2016) Aug 16-20 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC2016) Lake Buena Vista- Florida Aug 16-20 2016 Colorado Life Science Innovation Aug 26 2016 ESC list of exhibitors: ABT ABIO ACARIX ACTELION AMGN ASPEN AZN BAYER BMY BI CRME DAIICHI SANKYO EW EMCURE FERRER FMS GE GSK GLENMARK HIT MDT MRK NVS PHG PTLA RECORDATI RMD RHHBY REGN SNY SERVIER SHPG SI STJ TMO TOSHIBA ZOLL Aug 27-30 2016 EUROPEAN RESPIRATORY SOCIETY EXHIBITORS: ACTELION ADHERIUM AZN BAYER BI BSX CEMP CHIESI CIPLA COGENTIX CSL DDD FUJIFILM GSK GRFS HIT INSM LINDE NVS OXFORD IMMUNOTECH MUNDIPHARMA PFE PRXL PHG QGEN Q REGN RMD SNY TAKEDA TEVA UTHR ZAMBON and others Sep 3-7 2016 Arizona Bio Awards Sep 21 2016 AZ Bio Whitehat Investors-Phoenix , AZ Sep 21-22 2016 North Carolina Bio Annual Meeting Sep 29 2016 Reimbursement 101-201 Washington DC Sep 27-29 2016 Wearables Devices Webinar Regulatory and Litigation Sep 28 2016 510K Submissions Workshop – Washington DC Oct 31- Nov 1 2016

7th Annual Advertising and Promotion of Medical Devices Conf- Wash DC Nov 10-11 2016 Cybersecurity Summit – Wash DC Nov 16 2016 ICNC 2017 Nuclear Cardiology Conf – Vienna May 7-9 2017 EHRA Europace Cardiology Conf –Vienna Jun 18-21 2017 European Society Cardiology ESC 2017 –Barcelona Aug 26-30 2017

IBD Next generation diabetes drugs on tap, positive article, Leerink Seamus Fernandez sees blockbuster potential in both NVO Xultophy and SNY Lixilan, NVO Xultophy could have a slight upper hand in the drug/device profile and positioning in the treatment algorithm that could lead to better physician acceptance and market uptake.It remains to be seen how the competition will shape up, because of the different variables, the companies that will do best in diabetes are those with the broadest portfolios, says Les Funtleyder who cites LLY and NVO as having particularly comprehensive programs Commercial AR applications could explode in the next 5 years Cost of the US Water Retrofit Staggering municipal systems increasingly look to private water managers in order to upgrade supply, water system gets D grade AMZN groceries spark online rush from retail chains, e commerce leader’s growth could get another big boost from its push into groceries, TGT and KR are fighting back We Work large overview article, We Work which is one of the most valuable venture backed private companies, cut forecasts earlier this year and told employees it has to change its spending culture MNST Monster Beverage overview article, because MNST relies so heavily on one product investors need to have a larger margin of safety

Computer World Why a Verizon and Yahoo merger would be like Microsoft snapping up CompuServe VZ if this rumor about Verizon buying YHOO Yahoo for $5B is true, we have an honest to goodness schadenfreude moment for me as someone who remembers the days of the Buddy List, giant banner ads (which is actually still common at Yahoo Mail for some reason), and those plastic discs they might still sell at Walmart for gaining “high-speed As you may know, Verizon also owns AOL. Those three letters, combined with the Yahoo exclamation mark, create some vivid memories. Few of them are good ones. I remember having to wait for my modem to connect to AOL back in the day, and for the banner ads at Yahoo.com to finish loading. It’s a curious development, but it makes about as much sense as other luminous icons of tech combining into an ungodly entity driven by brand dominance. As much fun as it is to make fun of AOL, it has become more of a publisher of content than anything. They own Engadget, The Huffington Post, and TechCrunch among other things. Yet, if you asked anyone on a street corner about AOL, they’d laugh at you. “Wait, is that company still around? Do they still do dial-up?” What you may not realize even if you follow tech closely is that AOL has also become an investment arm buying other brands. It says that right on their Wikipedia page. If it means they are “investing” in the brand of Yahoo, we have some serious problems. Yahoo doesn’t have a brand. They have a tightly managed business operation without any creative ideas, which is exactly the opposite of a brand What is a homepage anyway? Most of us don’t go to Yahoo.com to finds the news, we click links on Facebook and on Twitter. We find them at

Google News. If you’re still going to Yahoo.com to “discover” things, you probably also wear tan Dockers. I know of a few companies that have decided to put a static image on their homepage. It doesn’t matter anymore. Content is shared on social, end of story. Here’s the other infuriating part of Verizon and AOL “purchasing” Yahoo assets. What assets? I know the one-time competitor to Google has some of the highest traffic on the planet, what with all of their weather apps and such. But even Google has figured out how to break free from the old “click my banner” trick so popular in 2007. Major companies like eyeballs, consumers like innovation. That’s the problem with investors who still use a BlackBerry. They want to buy a logo. They see brand acquisition as a conquest, not a business strategy. Yahoo is in a freefall. They don’t need a turnaround specialist, they don’t need more money. What they need is for someone to lead the company. They don’t need highly detailed reporting structures and massive 14GB spreadsheets in Excel. Where is the Yahoo driverless car? Where are the planes that deliver internet access to people in remote areas? The last thing we need is one archaic brand famous for free Walmart discs buying another archaic brand famous for banner ads that will then merge into one archaic brand that’s famous for absolutely nothing

WSJ The healing powers of venom, researchers are looking how to turn toxins into lifesaving treatments

BioWatch on Replicel Replicel on July 21, 2016 RepliCel Life Sciences (TSX : RP; OTCQB : REPCF) announced that its partner, Shiseido Company was cleared by the Japanese regulatory authorities to launch its hair follicle technology, RCH-01, to treat pattern baldness. The clinical trial aims to enroll 60 men and women with pattern baldness. A few years ago, we ran across RepliCel and was initially attracted by its seemingly unorthodox indications. We continue to watch tiny RepliCel because it encapsulates many important features to track: a relationship with Japan; unique regenerative technologies; and boutique underserved markets. When we wrote earlier this year, we said: RepliCel is definitely not for the faint of heart nor for the newbie investor. It has a difficult cash position and trades on the Toronto Stock Exchange (RP) and on the OTC Venture Marketplace (REPCF).At its current valuation, it is downright scary.RepliCel’s situation is unfortunate. If it was a Nasdaq company, we think it would have a more robust valuation. Good clinical results would then certainly bump the stock.It’s now a bit of a Hail Mary. RepliCel must receive positive trial results from its skin wrinkle and tendinosis trials. RepliCel then needs to attract another partner or search for a strategic alternative.If the valuation doesn’t budge even after good clinical results, then we can see multiple scenarios. The company could simply die, it could be purchased, or even taken private.

Bloomberg Business week Get Fit the growth of Michelob Ultra Light calorie beer The last days of Turkey’s Republic New Zion , Vermont , how Mormon David Hall wants to build a sustainable high tech high density community Falling drillers lose valuable insurance against falling oil prices, by selling all the hedges they are left burning cash now Sandstone Diagnostics Trak at home male fertility kit will be available OTC in Oct 2016

Kaiser Permanente is taking bids on the hospital of the future, 37,000 square foot R&D warehouse near San Leandro , doctors and nurses test new hardware and software and ask manufacturer to refine equipment based on staff and patient feedback

MDDI Medical Device and Diagnostic Industry Why is it so hard to innovate at Big medtech companies MDT finally reveals details on MDT’s Robotics Platform, MDT has been discussing its timeline with FDA the US won’t be the first region to see the robotics platform, the company is planning to launch the system first in India. MDT robotics platform to contribute material revenue growth by its fiscal year 2019. Verb Surgical the jv between JNJ and GOOG Verily is another of the growing number of companies converging on the robotic assisted surgery market. Verb expects to have a working prototype by the end of 2016. Frog Design Jonathan Grossman conceptualized a design for a dual nostril naloxone nasal atomizer a treatment used in case of opiod overdose Tips on how to compete in a bundled care environment, bundled payments in orthopedics could be an opportunity for smart medical device firms that are not afraid to change how they do businesses Will ZBMH Biomet spine investment meet its potential, WFC analyst remains suspect FDA updates IDE Device categorization for CMS coverage

Barron's 6 stocks that could surprise on earnings ATVI AH ANET FB SWHC SPLK PBMs Pharmacy-benefit managers highlighted: the Health Transformation Alliance, a coalition of 30 of the country’s biggest employers (including IBM KO and others) have come together with the goal of making prescriptions more affordable for their six million employees. The Alliance wants to re-write their pharmacy-benefit contracts to eliminate the undisclosed drug-price markups that account for much of the PBM industry’s profits. It could take several years to play out, but Express Scripts (ESRX) and CVS (CVS) could see their margins severely affected. UnitedHealth Group (UNH) has less of an immediate risk in the alliance's actions Chuck Royce likes KKR ARES LAZARD MTG MGIC, RDN Radian, ESNT could see gains. Barclays analyst Mark DeVries believes we are in for “a supercycle for mortgage credit that seems unlikely to be derailed by a recession, while independent housing analyst Ivy Zelman notes that "people under appreciate how low the claims rates are." Firmer pricing is also helping the group. Shares of the mortgage insurers are down sharply from a year ago and currently fetch single-digit P/E multiples. They could have 50% upside as the housing market continues to strengthen. CSWI positive article on CSW Industrials, a collection of industrial businesses spun off by Capital Southwest (CSWC) last September. The company's portfolio boasts businesses that are mostly high quality and high margin: its industrial and chemical products serve niche areas in commercial and residential construction, while other businesses serve the energy, transportation, and mining industries. The group has an opportunity to improve margins by integrating its manufacturing platform, and can also spur growth via cross-selling. A strong balance sheet and ample free cash flow could also allow for bolt-on acquisitions. Columbia Large Cap Growth Takes a Long View The CBO Looks Ahead To a U.S. Fiscal Disaster Time to Dump Utilities

European Fund Managers Plan Their Own "Brexits" Lovely Laggards: IBM and Cisco AIG Warrants a Look Lloyds, Royal Dutch Shell Among U.K. Bargains Now

Computer World Why a Verizon and Yahoo merger would be like Microsoft snapping up CompuServe VZ if this rumor about Verizon buying YHOO Yahoo for $5B is true, we have an honest to goodness schadenfreude moment for me as someone who remembers the days of the Buddy List, giant banner ads (which is actually still common at Yahoo Mail for some reason), and those plastic discs they might still sell at Walmart for gaining “high-speed As you may know, Verizon also owns AOL. Those three letters, combined with the Yahoo exclamation mark, create some vivid memories. Few of them are good ones. I remember having to wait for my modem to connect to AOL back in the day, and for the banner ads at Yahoo.com to finish loading. It’s a curious development, but it makes about as much sense as other luminous icons of tech combining into an ungodly entity driven by brand dominance. As much fun as it is to make fun of AOL, it has become more of a publisher of content than anything. They own Engadget, The Huffington Post, and TechCrunch among other things. Yet, if you asked anyone on a street corner about AOL, they’d laugh at you. “Wait, is that company still around? Do they still do dial-up?” What you may not realize even if you follow tech closely is that AOL has also become an investment arm buying other brands. It says that right on their Wikipedia page. If it means they are “investing” in the brand of Yahoo, we have some serious problems. Yahoo doesn’t have a brand. They have a tightly managed business operation without any creative ideas, which is exactly the opposite of a brand What is a homepage anyway? Most of us don’t go to Yahoo.com to finds the news, we click links on Facebook and on Twitter. We find them at Google News. If you’re still going to Yahoo.com to “discover” things, you probably also wear tan Dockers. I know of a few companies that have decided to put a static image on their homepage. It doesn’t matter anymore. Content is shared on social, end of story. Here’s the other infuriating part of Verizon and AOL “purchasing” Yahoo assets. What assets? I know the one-time competitor to Google has some of the highest traffic on the planet, what with all of their weather apps and such. But even Google has figured out how to break free from the old “click my banner” trick so popular in 2007. Major companies like eyeballs, consumers like innovation. That’s the problem with investors who still use a BlackBerry. They want to buy a logo. They see brand acquisition as a conquest, not a business strategy. Yahoo is in a freefall. They don’t need a turnaround specialist, they don’t need more money. What they need is for someone to lead the company. They don’t need highly detailed reporting structures and massive 14GB spreadsheets in Excel. Where is the Yahoo driverless car? Where are the planes that deliver internet access to people in remote areas? The last thing we need is one archaic brand famous for free Walmart discs buying another archaic brand famous for banner ads that will then merge into one archaic brand that’s famous for absolutely nothing.

Pharmaceutical News Today Aurobindo positive commentary by Dhananjay Sinha of Emkay Global Financial Services told CNBC-TV18, "After the sharp correction that has been happening over the last one year largely to do with the US FDA observations, etc and I think there has been a sharp correction that has

happened, so I think that part is actually fading out as of now. Within the pharmaceutical space, what we have seen is that pharmaceutical companies, smallcap pharmaceutical or midcap pharmaceutical companies who had lesser exposure to US and more exposure to other continents, they were actually outperforming." "However, going forward it does appear that the sense we are getting is that the concern on the US regulatory observations, etc is sort of fading out and I think people have found value over there. Aurobindo Pharma has generally been doing well. It has escaped many of these regulatory concerns, so Aurobindo has been our top pick for many years. It continues to be so and I think that has been doing well. So, that is one of our top pick," he added.

NY Post HSY nearing settlement in regards to the Milton Hershey trust that would provide the clarity for MDLZ to make a new offer, article in the NY POST VZ closes in near a $ 5 billion bid for YHOO core business, the price tag does not include YHOO’s patents but does include real estate VRX Bill Ackman hit with another Friday downer when the FDA failed to approve VRX Nivox glaucoma drug

Forbes pondering who takeover targets for PFE – SHPG or PTLA and takeover targets for for SNY- REGN or BIIB Part 2 of Todd Hagopian of Marketocracy take on deals: He is buying because he believes the biotech industry is ripe for acquisitions as large, cash-flow rich drug companies look for promising new products. This is the 2nd in a three-part series (Part 1) focusing on potential mergers and acquisitions in the biotech sector. SHPG is the most likely target for PFE becomes Shire (SHPG). SHPG actually agreed to be acquired by ABBV prior to the acquisition attempt falling through (on the same inversion fears that PFE’s AGN merger fell through). This is proof that, unlike TEVA, SHPG would be open to the idea of a major merger. The acquisition would be slightly smaller than the TEVA bid, probably valuing SHPG at around $50 Billion. Shire would allow them to make progress on many of the same goals that they had set out to accomplish with the TEVA and AGN bids in the past. PTLA Portola Pharmaceuticals (PTLA) has been linked to PFE in the past, and they are just about to hear back on a major FDA ruling on the first of their Factor Xa inhibiting anticoagulant, along with another Factor Xa inhibitor in late-stage development. In addition, PFE already is working with them on their Factor XA Portfolio, and this would be a small, easy acquisition for PFE to make, probably running them only about $2 Billion, which they could cover with cash. Pfizer obviously could wind up being linked to a number of smaller companies in the sector, but PTLA would make a lot of sense for them to snap up. SNY has been rejected by MDVN twice in the past month, and may be ready to walk away from the deal. The board, and the leadership, were extremely excited about the MDVN opportunity, and if they are beaten out, they will likely be on the prowl for a new acquisition target.If Sanofi decides to pursue a different target, Regeneron (REGN) pops up as a really interesting takeover target. SNY already quietly owns over 20% of REGN, which has fallen almost 40% from it’s high, allowing SNY to make a $50 Billion acquisition by only shelling out an additional $40 Billion. This would be a relatively cheap

path to make a major purchase, and REGN features patents which help the company specifically target the best candidates for therapeutic intervention, which would greatly assist SNY in its future drug development. SNY if Sanofi tires of the pursuit of an oncology partner, BIIB would make a very interesting acquisition partner. SNY would get ahold of BIIB’s extremely valuable MS franchise, which would be a different direction than they hoped, but would be a fantastic move for Sanofi over the long term. On top of that, BIIB currently trades at a 40% discount to its previous high, making it a fairly decent bargain at today’s prices, probably making for a $70 Billion acquisition.

Real Clear Health Saturday Aetna, Anthem Vow to Fight for Mergers, but is it Worth it? - Small, FH NY Governor Signs Tampon Tax - Naomi Jagoda, The Hill HHS: Better Language Access needed for Meaningful Access - Chin, HAB Humana Leaving "Substantially All" ObamaCare Markets - S. Ferris, Hill Crazy Experiment is Changing How Big Pharma Innovates - Fry, Fortune Donald Trump is Right About Pharma - Charles Rosen, Stat Light Weights can be Just as Effective as Heavy Ones - Reynolds, NYT DNA Pioneer James Watson: Cancer Moonshot is "Crap" - Begley, Stat The Health Trials of a Presidential Campaign Worker - Scott, NewsWorks Who Would Win, if Doctors Chose the Next President? - Field, Philly.com Can a Nurse Practitioner Replace a Physician? - Landon & Mafi, Slate Obamacare: What We Didn't See Coming - Jonathan Gruber, Politico Why are Doctors Plagued by Depression and Suicide? - J. Graham, Stat What Will Happen to Adult Children with Autism? - Harris, Next Avenue

Health news

AGN and AMGN news from Jul 22 that data from a Phase III study showed ABP 980, a biosimilar of Herceptin trastuzumab, was non-inferior to its reference product based on the proportion of patients with a pathologic complete response (pCR), the primary efficacy endpoint. The double-blind study enrolled 725 women with HER2-positive early breast cancer, and contained a neoadjuvant and adjuvant phase.The companies said the data "could not rule out superiority" of ABP 980 vs. Herceptin based on the endpoint, which had a prespecified equivalence margin of 13%. According to Amgen and Allergan, the upper end of the confidence interval was 13.4% on the endpoint. The companies said overall adverse events and immunogenicity were comparable between the compounds. Amgen hopes to submit ABP 980 to U.S. and EU regulators next year. ARE Alexandria Real Estate Equities is acquiring office complex One Kendall Square in Cambridge, Mass., for $725 million, according to a regulatory filing. The site is home to biotechs including Catabasis Pharmaceuticals Inc. (CATB), Applied Genetic Technologies Corp. (AGTC), Ra Pharmaceuticals Inc. and Visterra Inc.In the filing, Alexandria said the campus is 98.5% occupied, much of it rented at below-market rates. It expects to convert some offices in the complex into more lucrative laboratory space.

AMGN and AGN news from Jul 22 that data from a Phase III study showed ABP 980, a biosimilar of Herceptin trastuzumab, was non-inferior to its reference product based on the proportion of patients with a pathologic complete response (pCR), the primary efficacy endpoint. The double-blind study enrolled 725 women with HER2-positive early breast cancer, and contained a neoadjuvant and adjuvant phase.The companies said the data "could not rule out superiority" of ABP 980 vs. Herceptin based on the endpoint, which had a prespecified equivalence margin of 13%. According to Amgen and Allergan, the upper end of the confidence interval was 13.4% on the endpoint. The companies said overall adverse events and immunogenicity were comparable between the compounds. Amgen hopes to submit ABP 980 to U.S. and EU regulators next year.AMGN and AGN are partnered to develop four oncology biosimilars, including ABP 980,Earlier in July of 2016, AMGN granted Daiichi Sankyo Co. Ltd.) exclusive rights to commercialize nine biosimilars in Japan, including ABP 980 Chronos Therapeutics Ltd. acquired three preclinical programs focused on fatigue in multiple sclerosis, addictive behaviors and post-traumatic stress disorder from SHPG . SHPG received equity in Chronos, and is eligible for regulatory and sales milestones, plus royalties. Chronos will have global development and marketing rights. Shire will have a right of first negotiation for each program, as well as rights to reacquire programs if Chronos does not support the programs with a specified minimum investment. Chronos said the MS fatigue program is the most advanced of the three. Shire declined to disclose financial terms or clinical targets InflaRx GmbH did r\~$34 mil raise in a series C round. In June of 2016 InflaRx started the Phase II CARDIAC study of its IFX-1 to prevent severe systemic inflammation and organ dysfunction in patients undergoing complex cardiac surgery. The candidate is a humanized mAb targeting complement 5a (C5a), which is produced in large amounts during the early stages of an infection.The company plans to start two more Phase II studies of IFX-1

Jilin Zixin Pharma will invest $42 million in Nabsys 2.0, a US company that has developed a high-definition genome mapping technology. After the transaction, Zixin will own 67% of Nabsys. Nabsys, which claims to be an electronic mapping pioneer, uses proprietary chip-based nanodetectors for single-molecule DNA mapping. It expects its technology will allow structural variation analysis, genome mapping, and in the future, DNA sequencing. The fundraising values Nabsys at $63 million. JNJ inked a deal this week with 3D printing shop Materialise for titanium craniofacial implants customized to individual patients’ anatomies.Leuven, Belgium-based Materialise will print the Trumatch line of implants for J&J’s DePuy Synthes business, for treating patients with disorders of the face and skull. The companies have worked together on craniofacial technology for 6 years, Johnson & Johnson said.“The Trumatch CMF solutions portfolio includes several advanced technologies for facial reconstruction, orthognathic surgery, distraction, and cranial reconstruction,” DePuy Synthes EMEA VP Elmar Zurbriggen said in prepared remarks. “The agreement with Materialise will enable us to continue to bring more personalized solutions to the marketplace furthering our ability to improve patient care.”Materialise creates the implants using a computed tomography scan of the patient’s skull. The Trumatch line is slated to hit the market in Australia and Europe, J&J said. “The launch of Trumatch orthognathic and titanium 3D-printed implants is currently being rolled out in the EMEA countries,” Zurbriggen said. L’Oréal SA on Friday said it would acquire U.S.-based IT Cosmetics in a cash deal worth $1.2 billion.L’Oréal, home to brands including Lancôme, Garnier and Kiehl’s, will add IT Cosmetics’s stable of over 300 beauty products. For the 12 months ended in June, IT Cosmetics posted net

sales of $182 million, a 56% rise compared with a year ago, according to L’Oréal. IT Cosmetics products are available on shopping channels including QVC and TSC, specialty retailers such as Ulta Salon Cosmetics & Fragrance Inc. ’s stores and LVMH Moët Hennessy Louis Vuitton SE ’s Sephora locations and the brand’s website.After the completion of the deal, IT Cosmetics is slated to become part of L’Oréal’s Luxe division and will continue to operate out of its Jersey City, N.J., headquarters under its current leadership. The closing of the transaction is subject to regulatory approval. Materialise news that JNJ inked a deal with 3D printing shop Materialise for titanium craniofacial implants customized to individual patients’ anatomies.Leuven, Belgium-based Materialise will print the Trumatch line of implants for J&J’s DePuy Synthes business, for treating patients with disorders of the face and skull. The companies have worked together on craniofacial technology for 6 years, Johnson & Johnson said.“The Trumatch CMF solutions portfolio includes several advanced technologies for facial reconstruction, orthognathic surgery, distraction, and cranial reconstruction,”

Nabsys news that Jilin Zixin Pharma will invest $42 million in Nabsys 2.0, a US company that has developed a high-definition genome mapping technology. After the transaction, Zixin will own 67% of Nabsys. Nabsys, which claims to be an electronic mapping pioneer, uses proprietary chip-based nanodetectors for single-molecule DNA mapping. It expects its technology will allow structural variation analysis, genome mapping, and in the future, DNA sequencing. The fundraising values Nabsys at $63 million. SHPG news that Chronos Therapeutics Ltd. acquired three preclinical programs focused on fatigue in multiple sclerosis, addictive behaviors and post-traumatic stress disorder from SHPG . SHPG received equity in Chronos, and is eligible for regulatory and sales milestones, plus royalties. Chronos will have global development and marketing rights. Shire will have a right of first negotiation for each program, as well as rights to reacquire programs if Chronos does not support the programs with a specified minimum investment. Chronos said the MS fatigue program is the most advanced of the three. Shire declined to disclose financial terms or clinical targets VZ closes in near a $ 5 billion bid for YHOO core business, the price tag does not include YHOO’s patents but does include real estate YHOO VZ closes in near a $ 5 billion bid for YHOO core business, the price tag does not include YHOO’s patents but does include real estate XBIT XBiotech said today that the IDMC for the XCITE Phase III clinical study of Xilonix for the treatment of colorectal cancer, recently recommended study continuation without any amendment to the study design. The DMC convened as scheduled, subsequent to the enrollment of 400 patients into the study. The DMC mandate is to "monitor for early evidence of treatment harm and to routinely recommend to continue, suspend, or otherwise modify enrollment based on their findings." The DMC did not have any recommendations for the company regarding any need for changes to the study operation. This is viewed as a positive assessment with respect to safety, as well as to key aspects of study execution. Another DMC meeting is scheduled to occur either after 600 patients have been enrolled, or potentially earlier if the study meets its first planned efficacy analysis milestone.

Xilonix has been granted FDA fast-track review and the XCITE study is on schedule to reach its enrollment milestones in 2016. The company's marketing authorization application for Xilonix for the treatment of colorectal cancer remains on schedule to achieve a decision in 2016 by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). The company recently scheduled an in-person meeting with the CHMP.

STAT At scientific meetings on genome-editing, you’d expect researchers to show pretty slides of the ribbony 3-D structure of the CRISPR-Cas9 molecules neatly snipping out disease-causing genes in order to, everyone hopes, cure illnesses from cancer to muscular dystrophy. Less expected: slides of someone kneeling on a beach with his head in the sand. Yet that is what Dr. J. Keith Joung of Massachusetts General Hospital showed at the American Society of Hematology’s workshop on genome-editing last week in Washington. While the 150 experts from industry, academia, the National Institutes of Health, and the Food and Drug Administration were upbeat about the possibility of using genome-editing to treat and even cure sickle cell disease, leukemia, HIV/AIDS, and other blood disorders, there was a skunk at the picnic: an emerging concern that some enthusiastic CRISPR-ers are ignoring growing evidence that CRISPR might inadvertently alter regions of the genome other than the intended ones. Tim Kaine as prevention candidate of 2016, as the governor of Virginia, Kaine pushed to ban smoking in the state’s restaurants and made a priority of driving down infant mortality. As a senator, he called on doctors to stop prescribing so many opioids to help curb addiction.Marilyn Tavenner, president and chief executive officer of AHIP, who served as Virginia’s health secretary while Kaine was governor, recalled that he saw the prevention of health problems as a top-tier goal.That’s a new dimension that the Virginia senator and former governor is likely to add to Clinton’s campaign. Much of Clinton’s focus has been on the health care coverage side, and on medical research to find new cures.But for Kaine, keeping people from getting sick — and taking care of their health care needs at the front end — is just as important as figuring out how to get the best medical care after they’ve gotten sick.Tavenner, who also headed the CMS under President Obama, recalled that Kaine made his interests clear when she interviewed with him for the health secretary job.“He said, ‘Marilyn, maybe we should be a little more focused on health and a little less on the hospitals,'” Tavenner said — meaning, “the more we do on the front end, the less need we’ll have to send people to hospitals.”The prevention issue is a good match for Kaine’s overall political image. Like Kaine himself, preventive health care isn’t buzzy. But health care advocacy groups say it’s important and often overlooked, and they’ve spoken up when they believe it hasn’t gotten enough attention in major initiatives, as in Vice President Joe Biden’s cancer research program.Kaine has also stressed the importance of prevention to address the nation’s opioid epidemic. Legislation he introduced last year, which has since been approved by the Senate health committee, would encourage physicians to prescribe naloxone — a drug that’s used to reverse the effects of opioid or heroin overdoses — any time they prescribe painkillers.

San Diego Union Tribune on Summit for Stem Cell news and CIRM Summit for Stem a San Diego nonprofit has received a $2.4 million grant from California's stem cell agency. The group, proposes to replace brain cells destroyed by Parkinson's with replacement brain cells. These cells make the neurotransmitter dopamine, which enables

movement. Success could relieve symptoms for many years, giving patients a normal life. Cheers erupted from group members after the CIRM California Institute for Regenerative Medicine's governing board approved the funding and other research grants at its meeting Thursday in La Jolla. California voters created CIRM in 2004 under Proposition 71, appropriating $3 billion in bond money to fund its work. "I've wanted to believe this was going to happen for so long," said group member Cassandra Peters, who has Parkinson's. "Today, I'm going to go home, look in the mirror, and say, 'Parkinson's, your days are numbered in this house.'" The grant enables the group to get near the point where it can ask regulatory permission to begin clinical trials, said Scripps Health neurologist Dr. Melissa Houser, who leads clinical development. Stem cell researcher Jeanne Loring of The Scripps Research Institute leads the basic research. Summit for Stem Cell is a volunteer non-profit partnership including patients, patient advocates and scientists. It is led by scientists and and medical professionals from Scripps Health and The Scripps Research Institute. It can be reached at summitforstemcell.org. Its members, including some Parkinson's patients, are training to climb Machu Picchu in Peru this October. With the funds and volunteer support, researchers have created the replacement neurons, derived from artificial stem cells called induced pluripotent stem cells. Those IPS cells were grown from the Parkinson's patients themselves. Because the cells came from the patients to be treated, they are genetically matched, which should reduce the risk of immune rejection. Safety testing of the transplants have been performed in animals, but more work is needed to satisfy concerns of the FDA. The group has had very early discussions with the FDA, and more discussions lie ahead before the group can file an application asking authorization. "CIRM has granted us the ability to further refine our cells, make sure our cell lines are pure, and get them to the point where we feel they're safe for implantation into the human brain," Houser said. “We will get to the point with the FDA where we will find out what we need to guarantee safety.” If all goes well, the group will be ready to file an application in about a year, she said. More money will be needed, and the group will be fundraising the whole time, as with the Machu Picchu expedition. Members of that expedition must pay their own way, in addition to raising funds for the group. After the CIRM meeting, the group met with its president, C. Randal Mills, who reassured members that the agency is committed to helping the Parkinson’s project succeed. Mills responded to a question from TSRI’s Loring, who asked how CIRM could better inform funding applicants about what is needed to meet the FDA’s criteria. “It would be great if we could have more advice . if we could get feedback from other people who have had different views of the FDA, for example,” Loring said. Mills replied that the group will get that advice, now that it’s a CIRM-funded program. “The good news is now, we can,” Mills said. “We’re not a consulting agency to everyone. That’s not a possible thing for us to do. But for the programs that are ours -- they’re ours. We’re all in on that.” CIRM has internal milestones based on how well its funded programs progress, Mills said.

Venture Beat on Israel’s new cybersecurity hub Be’er Sheva, . An ancient-made-modern city in southern Israel has become the center of Start-Up Nation’s quickly growing cybersecurity arm.A major push by the government and private sector has transformed the desert town into a high-tech center with a special emphasis on cybersecurity. Dozens of startups have joined multinationals such as EMC/RSA, Lockheed-Martin (LM), and others in opening R&D labs there, and they have drawn in impressive talent.

The result, to date, is a budding ecosystem of bright minds, dedicated to a common goal of developing world-class cybersecurity technology. Dubbed the “Capital of the Negev Desert,” Be’er Sheva has been locally known as a dusty pit stop between Tel Aviv and tourist destinations in the south of Israel. However, that’s no longer the case. Low real estate prices and new transportation options, including advancements to railway and highway systems, are facilitating a southbound migration. Making the move are ordinary Israelis and tech gurus, as well as some government offices and parts of the Israeli Army (IDF). And then there is Ben Gurion University (BGU), which offers Israel’s top graduate program in cybersecurity. Housing its own cybersecurity research institute, BGU has emerged as a top Israeli center for engineering, sciences, computers, and technology. With this mix of people, energy, facilities, and resources in place, sooner or later, something was going to spark a cyber-tech revolution. That spark was lit in 2013, with the opening of the Gav-Yam Negev Advanced Technologies Park, a billion dollar facility, funded mostly by the Israeli government and Ben Gurion University. Almost immediately, companies large and small – many of them in the cybersecurity space – established themselves in the new innovation center, even when it was still in the planning stages. Among the first to head south was EMC/RSA. In 2014, the company signed a deal with US defense firm Lockheed Martin and BGU to seek out promising Israeli cybersecurity startups and help them develop their technologies into commercial products. Other multinationals that have opened R&D labs and facilities in Be’er Sheva include Deutsche Telekom (which established its Israeli T-Labs branch in Be’er Sheva to collaborate with BGU), Mellanox, and IBM. Several incubators have sprung up at the site as well, including one run by Jerusalem Venture Partners (JVP), Israel’s largest and best performing venture capital firm, which is also the most active investor in early stage Israeli cybersecurity startups. For these reasons, there are dozens of startups, which now call Be’er Sheva home, including many cybersecurity firms. This swarm of startups also led coworking-space operator WeWork to choose Be’er Sheva as its third location

HCV Advocate Kentucky had the highest increase in the nation in the rate of hepatitis C infections among women ages 15-44 in recent years, according to a new federal report that offers further evidence of growing problems in the state from intravenous drug use. The Centers for Disease Control and Prevention released the report this week on the rise in hepatitis C cases across the U.S. and in Kentucky. Nationwide, the rate of women of childbearing age — defined as 15 through 44 — who tested positive for hepatitis C increased by 22 percent between 2011 and 2014, the year with the latest data, the CDC said.

CBI Insights on Digital health deals Digital health has enjoyed continuous growth in recent years, with at least four years straight of deal growth and 2015 seeing nearly 1,000 deals and more than $5.5B invested. This represents more than a 100% increase in deals and more than a 220% increase in funding since 2012. Funding in 2016 has remained high with more than $3.5B invested thanks to several $100M+ deals in Oscar Health, Flatiron Health, Spring Rain Software. However, deal activity has started slowly, with just 476 deals in the 2016 (and Q2’16 seeing a plunge in deals versus the previous quarter), putting it on course to fall below the number of deals in 2015.

When we look at the quarterly trend, the Q2’16 dropoff becomes more clear. Q2’16 has been the first quarter with sub 200 deals since Q4’14, and is a 27% decrease from the previous quarter. 8 of the last 10 quarters have seen more than $1B in financing.Digital health quarterly q2 2016 By stage, early stage deal share continues to increase taking 3/4ths of all deals in 2016 while late stage deals (Series D and later) have shrunk. Deal share to all other stages remained relatively range bound. By geography, there have been more than 50 international digital health deals, especially in India (PurpleHealth, DocsApp) and China (iCarbonX, Anhao). Within the US, California continues to dominate deals, with more than 45 in the quarter, followed distantly by New York. Missouri and Florida both saw 7 deals to round out the top 4.

July 22 2016

New health events to add AVXL at AAIC Jul 23-28 2016 ALNY and SNY data at WFH Jul 24-28 2016 BAYER at WFH Jul 24-28 2016 Biotest at WFH Jul 24-28 2016 BIIB and SOBI at WFH Jul 24-28 2016 BMRN at WFH for BMN 270 Jul 24-28 2016 CSL Behring at WFH Jul 24 -28 2016 GRFS at WFH Jul 24-28 2016 Kedrion Biopharma at WFH Jul 24 -28 2016 LFB at WFH Jul 24-28 2016 NVO at WFH Jul 24-26 2016 Octapharma at WFH Jul 24-28 2016 QURE AMT -060 data at WFH Jul 24-28 2016 RHHBY at WFH Jul 24-28 2016 SHPG BXLT at WFH Jul 24-28 2016 SNY and ALNY data at WFH Jul 24-28 2016 SOBI and BIIB at WFH Jul 24 -28 2016 MNOV analyst meeting Jul 26 2016 KDMN Kadmon IPO due Jul 26 2016 BIOV Bioventus IPO due Jul 28 2016 Astellas 1q 2017 analyst meeting Jul 29 2016 Hoya analyst meeting Jul 29 2016 Daiichi Sankyo analyst meeting Jul 29 2016 Kyowa Hakko Kirin analyst meeting webcast Jul 31 2016 ABT at AACC Jul 31- Aug 4 2016 A at AACC Jul 31- Aug 4 2016 ALR at AACC Jul 31- Aug 4 2016 ALXN at AACC Jul 31- Aug 4 2016 BIO at AACC Jul 31- Aug 4 2016 CPHD at AACC Jul 31- Aug 4 2016 CEMI at AACC Jul 31- Aug 4 2016

DGX at AACC Jul 31- Aug 4 2016 GE at AACC Jul 31- Aug 4 2016 GRFS at AACC Jul 31- Aug 4 2016 HAE at AACC Jul 31- Aug 4 2016 HIT at AACC Jul 31- Aug 4 2016 HOLX at AACC Jul 31- Aug 4 2016 IART at AACC Jul 31- Aug 4 2016 LMNX at AACC Jul 31- Aug 4 2016 NSPH at AACC Jul 31- Aug 4 2016 OSUR at AACC Jul 31- Aug 4 2016 PLXS at AACC Jul 31- Aug 4 2016 RHHBY at AACC Jul 31- Aug 4 2016 QGEN at AACC Jul 31- Aug 4 2016 QUANTERIX at AACC Jul 31- Aug 4 2016 SI at AACC Jul 31- Aug 4 2016 SIAL at AACC Jul 31- Aug 4 2016 SRDX at AACC Jul 31- Aug 4 2016 TECAN at AACC Jul 31- Aug 4 2016 TAIGEN at AACC Jul 31- Aug 4 2016 TMO at AACC Jul 31- Aug 4 2016 VIVO at AACC Jul 31- Aug 4 2016 WAT at AACC Jul 31- Aug 4 2016 ZBRA at AACC Jul 31- Aug 4 2016 UMN Pharm analyst meeting Aug 1 2016 Shionogi analyst meeting Aug 1 2016 AZN roadshow Aug 1-4 2016 Santen Pharmaceutical analyst meeting Aug 2 2016 Mitsubishi Tanabe Pharma analyst meeting Aug 2 2016 Eisai analyst meeting Aug 3 2016 Terumo analyst meeting Aug 4 2016 Medical Data Vision analyst meeting Aug 8 2016 Oncolys Biopharma analyst meeting Aug 10 2016 RaQaulia Pharma analyst meeting Aug 11 2016 SYT Chem China ACCC decision due Sep 15 2016 UDG Healthcare Capital Markets Day Sep 27 2016 LLY guidance call Jan 4 2017 AMGN UCB possible BLA date for romosozumab, a treatment of osteoporosis in postmenopausal women at increased risk of fracture( news on submission Jul 22 2016) possible BLA date Jul 24 2017 UCB AMGN possible BLA date for romosozumab, a treatment of osteoporosis in postmenopausal women at increased risk of fracture( news on submission Jul 22 2016) possible BLA date Jul 24 2017 Wells Fargo Biotech Access Day ALNY BIIB BLUE MACK TSRO- Boston Jul 26 2016 Sachs Associates 16th Annual Biotech Global partnering conf- Switzerland Sep 27-28 2016

Annual meetings in health space to add RDY annual meeting Jul 26 2016 MCK annual meeting Jul 27 2016 JNP annual meeting Jul 27 2016 GSK annual meeting Jul 28 2016 EXAS annual meeting Jul 28 2016 COCP annual meeting Jul 28 2016 BVX annual meeting Jul 28 2016 NVS annual meeting Jul 29 2016 PBH annual meeting Aug 2 2016 TTNP annual meeting Aug 2 2016 EGRX annual meeting Aug 2 2016 STE annual meeting Aug 2 2016 FLDM annual meeting Aug 3 2016 JAZZ annual meeting Aug 4 2016 PLX annual meeting Aug 7 2016 ABMD annual meeting Aug 10 2016 Mologen annual meeting Aug 11 2016 NAVB annual meeting Aug 11 2016 Medigene AG annual meeting Aug 11 2016 EBIO special meeting Aug 15 2016 QSII annual meeting Aug 16 2016 LBIO annual meeting Aug 16 2016 ONVO annual meeting Aug 17 2016 HEB annual meeting Aug 17 2016 ENZY annual meeting Aug 25 2016 Stada Arzneimittel AG annual meeting Aug 26 2016

Deletion NICOX pdufa date due to CRL news

Computer World Why a Verizon and Yahoo merger would be like Microsoft snapping up CompuServe VZ if this rumor about Verizon buying YHOO Yahoo for $5B is true, we have an honest to goodness schadenfreude moment for me as someone who remembers the days of the Buddy List, giant banner ads (which is actually still common at Yahoo Mail for some reason), and those plastic discs they might still sell at Walmart for gaining “high-speed As you may know, Verizon also owns AOL. Those three letters, combined with the Yahoo exclamation mark, create some vivid memories. Few of them are good ones. I remember having to wait for my modem to connect to AOL back in the day, and for the banner ads at Yahoo.com to finish loading. It’s a curious development, but it makes about as much sense as other luminous icons of tech combining into an ungodly entity driven by brand dominance. As much fun as it is to make fun of AOL, it has become more of a publisher of content than anything. They own Engadget, The Huffington Post, and TechCrunch among other things. Yet, if you asked anyone on a street corner about AOL, they’d laugh at you. “Wait, is that company still around? Do they still do dial-up?” What you may not realize even if you follow tech closely is

that AOL has also become an investment arm buying other brands. It says that right on their Wikipedia page. If it means they are “investing” in the brand of Yahoo, we have some serious problems. Yahoo doesn’t have a brand. They have a tightly managed business operation without any creative ideas, which is exactly the opposite of a brand. If you’re going to go after something that is a brand, pick a company that delights people, that causes warm feelings, that generates incredibly creative products and services that change lives. Don’t snap up a company that still shows huge banner ads in their mail program or has a homepage that looks like someone puked a food truck. (Better yet, don’t buy a company that still emphasizes their homepage in the first place.) What is a homepage anyway? Most of us don’t go to Yahoo.com to finds the news, we click links on Facebook and on Twitter. We find them at Google News. If you’re still going to Yahoo.com to “discover” things, you probably also wear tan Dockers. I know of a few companies that have decided to put a static image on their homepage. It doesn’t matter anymore. Content is shared on social, end of story. Here’s the other infuriating part of Verizon and AOL “purchasing” Yahoo assets. What assets? I know the one-time competitor to Google has some of the highest traffic on the planet, what with all of their weather apps and such. But even Google has figured out how to break free from the old “click my banner” trick so popular in 2007. Major companies like eyeballs, consumers like innovation. That’s the problem with investors who still use a BlackBerry. They want to buy a logo. They see brand acquisition as a conquest, not a business strategy. Yahoo is in a freefall. They don’t need a turnaround specialist, they don’t need more money. What they need is for someone to lead the company. They don’t need highly detailed reporting structures and massive 14GB spreadsheets in Excel. Where is the Yahoo driverless car? Where are the planes that deliver internet access to people in remote areas? The last thing we need is one archaic brand famous for free Walmart discs buying another archaic brand famous for banner ads that will then merge into one archaic brand that’s famous for absolutely nothing.

YCBB BYD sputtering electric car maker BYD (HKEx: 1211; Shenzhen: 002594) is making some big adjustments in a bid stabilize its financial footing, with word of a major new share sale that includes the addition of Korea’s Samsung (Seoul: 005930) as a stakeholder. At the same time, that same new share issue has further diluted one of the company’s oldest and most loyal stakeholders, US billionaire investor Warren Buffett. Following this latest shift, Buffett’s holdings in the company are about half of what they were when he first purchased nearly 10 percent of BYD in 2008, when it looked poised to become a new energy car superstar FB is back in the China headlines, with word of a major executive poach from China’s leading SNS company. This particular headline is filled with mixed signals. On the one hand, the hire of a former top executive from WeChat looks like a significant move closer to China, since the hugely popular Chinese SNS operator would be Facebook’s main rival if it’s ever allowed into China. But on the other hand, the executive is a foreigner from WeChat’s international division, which has been a poor performer in the service’s weak attempts to go global

Real Clear Health Friday ACA Premiums Are Lower Than You Think - Adler & Ginsburg, HAB DOJ Suing to Block Health Insurance Mergers - Sarah Ferris, The Hill

Where Does Mike Pence Stand On Health Policy? - Jake Harper, WFYI Officials Rule Out Sex, Travel in Florida Zika Case - Fox News Health Data Should Belong to Patients - Angela Woodall, MedCityNews Updated Brain Map Identifies Nearly 100 New Regions - C. Zimmer, NYT Report: ACA Medicaid Enrollees Exceed Cost Estimates - B. Blase, Forbes Med. Groups Back Bill to Protect Doctor Payment Info - Silverman, Stat The AIDS Activist and the Banker - Patricia Sellers, Fortune In the Shadow of the RNC, ACA Pays Big Dividends - Jonathan Cohn, HP Pancreatic Cancer Community Crowdsources Treatments - Baum, MCN Generic Crestor Approved, Dealing a Blow to AstraZeneca - Pollack, NYT What is Hormonal Contraception's Role in HIV? - Cherpes, Conversation Psychotherapy Helps People Tune Out the Din Of Tinnitus - Bichell, NPR CMS Targets Heart Disease with New Program - Lauren Clason, The Hill

Health Wonk Blog Review InsureBlog, Henry Stern offers up ObamaTax subsidy news, Stern’s take on newly proposed IRS regulations regarding the Affordable Care Act’s premium tax credits. I think it’s safe to say – if not from his conclusion alone – that Henry wouldn’t call the new regs tremendous. How are they going to enforce this? It’s almost as if they have no idea what they’re doing. President Obama Writes About Health Care Reform in JAMA, Population Health Blog’s Jaan Sidorov examines a first: a peer-reviewed medical journal article published in JAMA by a sitting president. Unfortunately, Sidorov isn’t impressed, because he believes the president didn’t tell the whole truth.The reader is instead treated to an Affordable Care Act (ACA) legacy-building “bus tour” of selected facts and gratuitous framing of the Affordable Care Act (ACA). Louise Norris has a classy explainer on Congressional legislation in HR 5447 – Should employers be allowed to reimburse individual health insurance premiums? The legislation – which passed the House and is with the Senate now – would allow employers to contribute to their employees’ individual health insurance premiums, up to a maximum of $5,130 for a single employee, or $10,260 if the reimbursement also includes an employee’s family members.Obamacare. Replace it with something really terrific? Healthinsurance.org Blog, Lisa Zamosky has her own explainer – Healthcare sharing ministries: A leap of faith? – about why thousands of Americans are abandoning Obamacare and flocking to healthcare sharing ministries. Among the post’s five things you need to know: the ministries are not health insurance. Health System Ed’s Peggy Salvatore sent us The Public Option or (ahem) Single-Payer: Solutions to a Growing Healthcare Monster. Could Single Payer be the political solution “to a growing monstrosity of a problem high on the agenda of both parties”? She writes: At some point, the focus needs to return to a simple transaction between a patient and a healthcare provider where the only issue on the table is the patient’s health. Perhaps the only way to make that happen is to remove business from the business of healthcare and provide a universal option. Health Business Blog’s David Williams says we need to look no further than the dialysis industry, a convoluted and problematic corner of the industry. There is plenty of blame to go around.

Workers Comp Insider Tom Lynch at Workers’ Comp Insider reviews an extensive evaluation of a Massachusetts ACO. The evaluation essentially reaffirms Lynch’s own glowing review of Commonwealth Care Alliance. Lynch writes:Achieving the Triple Aim of improving the health of America’s dual population while lowering the cost of doing so is a rabbit-out-of-the-hat trick of the first order, but, at least to this point, Commonwealth Care Alliance seems to be onto something that will do just that. Managed Care Matters Joe Paduda was all about the opioids this week, Paduda dives into physician and pharmacist reluctance to support prescription monitoring programs. (Paduda notes that if not for the docs writing scripts, we wouldn’t be in an opioid crisis today.)Purdue Knew, Paduda highlights key sections from an LA Times article detailing what Purdue pharma knew about rampant overprescribing of Oxycontin, and when they knew it, and what they did about it. “Which would be, in a word, nothing,” Paduda notes. The Healthcare Economist investigates since we’re on the topic of prescriptions, Jason Shafrin, asks, Will value-based pricing be coming to the U.S.? Shafrin notes that value-based pricing increases the price for drugs shown to be effective in the real-world and decreases the price for those that do not. Are the legal barriers to this form of reimbursement falling by the wayside? Health Care Renewal Roy Poses sends us Abort, Retry, Fail – Billionaire Bill Gates Opines, Sans Evidence, on … the Efficacy of Hepatitis C Treatment? In the post, Poses looks at the actions of major foundations – like those led by “the Bills” (Clinton and Gates) – “which have the potential to make real improvements in U.S. and global health care … but instead … seem to be functioning like marketing and public relations auxiliaries of big health care corporations.” Health Affairs Blog We’ve got two great posts this week looking at the future of our healthcare system.David Cutler, writing at Health Affairs Blog, takes a look at the big – make that yuuuuuuuge – picture in Health Expenditure Projections: When Does ‘New’ Become ‘Normal’? Cutler looks at new CMS projections: 1. an average rate of national health spending growth of 5.8 percent from 2015 to 2025 and 2. that the health share of the economy will be 20.1 percent at the end of this period. But “forecasting is an inexact science,” says Cutler, who offers four reasons to think that the Actuaries may have overstated the path of medical spending. The Hospital Leader Brad Flansbaum posted The Next Hospital Decade: Broken Hips Versus Band-Aid Strips. His post is chock full of “choice charts” from MedPAC – and, Flansbaum notes: “It won’t take long to figure out the theme. A clue:”– 2016: Go to your local hospital and get your hip replaced; we can check up on that sore throat and lower back of yours as well.– 2026: Go to your local hospital to get that throat and back examined; let’s check up on that sore hip while you are here. You’re disgusting. HealthBlawg David Harlow tackles a more important question in Is a Ransomware Attack a Data Breach? Maybe. Harlow notes that the federal government recently issued guidance essentially saying that any ransomware attack – “malicious cyber-attacks on electronic health information systems” – should be reported as a data breach. Harlow takes a look HHS’s rationale and he’s skeptical.“While they certainly have the discretion to do so, it seems that this is pushing things a bit too far. What do you think?”

Health news ANTM BBerg has story reporting that BCS says they are likely to scrap deal, Barclays:s

Expect to see termination agreement in “relatively” near term given “animosity” between Cigna/Anthem; would be “uphill battle” in court case against DOJ block, Barclays analyst Josh Raskin wrote in note.Deal termination would allow both cos. to take part in divestitures that may occur with Humana/Aetna deal; Cigna could see as much as $1.2b in termination fees that it could use for buybacks, investments in core business Probable settlement with DOJ for HUMAET and even if no settlement, AET has “relatively strong case” if it goes to court. Possible “damage” for DOJ losing in court is “as high for the federal government as it is for Aetna, as definition of ‘Medicare market’ has never been ruled upon” AET mentioned in a BBerg has story reporting that BCS says they CI and ANTM are likely to scrap deal, Expect to see termination agreement in “relatively” near term given “animosity” between Cigna/Anthem; would be “uphill battle” in court case against DOJ block, Barclays analyst Josh Raskin wrote in note.Deal termination would allow both cos. to take part in divestitures that may occur with Humana/Aetna deal; Cigna could see as much as $1.2b in termination fees that it could use for buybacks, investments in core business Probable settlement with DOJ for HUMAET and even if no settlement, AET has “relatively strong case” if it goes to court. Possible “damage” for DOJ losing in court is “as high for the federal government as it is for Aetna, as definition of ‘Medicare market’ has never been ruled upon” AGN EU's CHMP adopted a positive opinion recommending the granting of a marketing authorisation for Truberzi to treat IBS-D AMAG Pharma says that on July 19 it received notice from FDA that Prior Approval Supplement for Coldstream Laboratories, (owned by Piramal Enterprises) was approved for the manufacture of single-dose, 1 mL, preservative-free formulation of Makena. AMGN and UCB filed Biologics License Application with FDA for romosozumab, a treatment of osteoporosis in postmenopausal women at increased risk of fracture.Application based on FRAME study; data to be presented at upcoming medical congress, possible BLA date Jul 24 2017 Almirall announces it is to acquire global marketing rights for PAT-001 from Patagonia. Under the terms of the transaction, Almirall will make an initial payment of $ 3.5M. Patagonia could receive additional payments for development and regulatory milestones of up to $24M. In addition, Patagonia could receive milestone payments on sales and double-digit royalties. It is expected that the sales peak PAT -001 is to exceed $100M. ATHN COO Ed Park to Step Down at Year End) -- Park seen elected to board. Upon Park’s anticipated transition to the board, Kyle Armbrester, senior vice president and chief product officer, will take on responsibility for direction and delivery of core services Biofrontera EU's CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for Biofrontera's Ameluz The CHMP adopted an extension to the existing indication as follows: "Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization BMY EU's CHMP adopted a positive opinion recommending the granting of a marketing authorisation for Bristol-Myers Squibb's Orencia i The CHMP adopted a new indication for Orencia in combination with methotrexate as follows: “the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.” BGNE FDA granted the company orphan drug designation for its compound to treat chronic lymphocytic leukemia.

BIIB got U.S. civil investigative demands for documents and information relating to its treatment of certain service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid Drug Rebate Program on Jul 1 2016 BXLT EU's CHMP adopted a positive opinion recommending the granting of a marketing authorisation for Baxalta's Onivyde The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Onivyde, intended for the treatment of metastatic adenocarcinoma of the pancreas. Onivyde was designated as an orphan medicinal product on 9-Dec-11. The applicant for this medicinal product is Baxalta Innovations GmbH. Onivyde will be available as a concentrate for solution for infusion (5.0 mg/ml). Cassiopea has taken control of a Phase II trial after BioMas the company Cassiopea licensed the drug from shutdown mid-study. The difficulties mean the genital wart trial has enrolled 27 patients almost three years after the protocol was filed with ClinicalTrials.gov, a situation that has forced Cassiopea to step in to prevent further delays to the study.Cosmo Pharmaceuticals Cassiopea’s parent company, picked up the rights to the genital wart drug CB-06-02 from Israeli biotech BioMas in 2014. That agreement gave BioMas responsibility for wrapping up a Phase II proof-of-concept trial designed to show whether CB-06-02, an asset based on the rare element tellurium, could decrease the number of warts and size of the infected area by supporting the body’s immune response against the human papilloma virus. Cassiopea has taken control of the trial and is claiming it is back on track. That track is a lot longer than it once was, though. Until recently, Cassiopea was still claiming data were due in the first half of 2016. The company now says it is unlikely to have the results until the second half of 2017. The delay was one of two setbacks disclosed by Cassiopea in its half-year report. The other, less severe, delay relates to a Phase II proof-of-concept trial of acne treatment CB-06-01. Having told investors to expect data in the first half of 2016, Cassiopea has now pushed back the forecasted date of the readout to next month. Cassiopea will use the data as the basis for a go/no-go decision that it expects to take by the end of the year. . The top priority for Cassiopea is Winlevi, an anti-androgen acne drug that is in Phase III. With one-third of the targeted number of participants now enrolled in the trial, Cassiopea is on track to deliver data late next year, a timeline that would position it to file for approval by mid-2018. Valeant (VRX) has first refusal on the drug if Cosmo wants to make a deal. The success, or otherwise, of that program will go a long way to dictating how well Cassiopea fares as an independent company in the near to mid-term. Cosmo spun off its dermatology assets to form Cassiopea last year, going on to raise CHF 175.6 million ($178 million) in an IPO. The IPO broadened Cassiopea’s shareholder base, but still left Cosmo holding approximately half of the company CI ANTM BBerg has story reporting that BCS says they are likely to scrap deal, Barclays:s Expect to see termination agreement in “relatively” near term given “animosity” between Cigna/Anthem; would be “uphill battle” in court case against DOJ block, Barclays analyst Josh Raskin wrote in note.Deal termination would allow both cos. to take part in divestitures that may occur with Humana/Aetna deal; Cigna could see as much as $1.2b in termination fees that it could use for buybacks, investments in core business. Probable settlement with DOJ for HUMAET; and even if no settlement, AET has “relatively strong case” if it goes to court. Possible “damage” for DOJ losing in court is “as high for the federal government as it is for Aetna, as definition of ‘Medicare market’ has never been ruled upon”

COCP announced that Gary Wilcox will assume the role of interim CEO effective today Jeffrey Meckler, the former CEO, and Dr. Douglas Mayers, the CMO, have stepped down. Cosmo Pharmaceuticals spun off its dermatology assets to form Cassiopea last year, going on to raise CHF 175.6 million ($178 million) in an IPO. The IPO broadened Cassiopea’s shareholder base, but still left Cosmo holding approximately half of the company. Fierce Biotech reviews Cassiopea news: the drug from shutdown mid-study. The difficulties mean the genital wart trial has enrolled 27 patients almost three years after the protocol was filed with ClinicalTrials.gov, a situation that has forced Cassiopea to step in to prevent further delays to the study.Cosmo Pharmaceuticals Cassiopea’s parent company, picked up the rights to the genital wart drug CB-06-02 from Israeli biotech BioMas in 2014. That agreement gave BioMas responsibility for wrapping up a Phase II proof-of-concept trial designed to show whether CB-06-02, an asset based on the rare element tellurium, could decrease the number of warts and size of the infected area by supporting the body’s immune response against the human papilloma virus. Cassiopea has taken control of the trial and is claiming it is back on track. That track is a lot longer than it once was, though. Until recently, Cassiopea was still claiming data were due in the first half of 2016. The company now says it is unlikely to have the results until the second half of 2017. The delay was one of two setbacks disclosed by Cassiopea in its half-year report. The other, less severe, delay relates to a Phase II proof-of-concept trial of acne treatment CB-06-01. Having told investors to expect data in the first half of 2016, Cassiopea has now pushed back the forecasted date of the readout to next month. Cassiopea will use the data as the basis for a go/no-go decision that it expects to take by the end of the year. . The top priority for Cassiopea is Winlevi, an anti-androgen acne drug that is in Phase III. With one-third of the targeted number of participants now enrolled in the trial, Cassiopea is on track to deliver data late next year, a timeline that would position it to file for approval by mid-2018. Valeant (VRX) has first refusal on the drug if Cosmo wants to make a deal. The success, or otherwise, of that program will go a long way to dictating how well Cassiopea fares as an independent company in the near to mid-term DXCM FDA advisory committee votes in favor of non-adjunctive label for G5 Mobile CGM system Announced that the Clinical Chemistry and Clinical Toxicology Devices Panel of the FDA voted in favor of the proposed non-adjunctive indication for the DexCom G5 Mobile CGM system. This indication would designate the G5 Mobile CGM system as a replacement to fingerstick glucose testing for diabetes treatment decisions. : "This recommendation is a big milestone for people with diabetes," said Kevin Sayer, DexCom President and CEO. "The diabetes community turned out in force to support this decision. We commend the FDA for bringing this important subject into a public forum, and thank the panel members, as well as the public speakers for their willingness to participate. We look forward to continued positive discussions with the FDA as we seek the agency's approval of our application." DXCM had conference call today EISAI EMA CHMP issues a positive opinion for Kisplyx (lenvatinib) in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The opinion was issued following the evaluation of results from a pivotal Phase II trial, which show lenvatinib plus everolimus significantly extends progression-free survival in patients with unresectable advanced renal cell carcinoma versus everolimus alone.

EMA on Jul 21 2016, the EMA outlined proposed topics to consider as part of a planned revision to the agency's 2007 guideline on first-in-human clinical trials. Comments on the paper are due Sept. 30, and EMA expects to publish a new draft guideline by YE16. In the paper, the agency said many first-in-human studies now use integrated protocols that combine different designs. The existing guideline focuses on single-ascending dose designs, reflecting common practice when it was drafted. The paper said EMA will consider ways to better integrate toxicology data into an overall risk assessment for first-in-human and other early clinical trials, and ways to handle adverse events with regard to stopping rules and progression to next dosing steps. EYES Second Sight says it got positive five-year outcomes associated with patients using the Argus II Retinal Prosthesis System (Argus II). Results showed patients’ visual function improved after implantation with Argus II; improvements sustained over 5-yrs Says earlier results from this trial were used to gain FDA approval of Argus II in addition to CE Mark in Europe Current research efforts include feasibility study of Argus II for individuals with dry age-related macular degeneration, hardware and software upgrades for existing/future Argus II patients, development of advanced visual prosthesis, Orion I EXEL IPSEN EU's CHMP adopted a positive opinion recommending the granting of a marketing authorization to Ipsen for Cabometyx The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabometyx, intended for the treatment of advanced renal cell carcinoma (RCC). Cabometyx will be available as 20 mg, 40 mg and 60 mg film-coated tablets FMS negotiations to acquire PFE pumps and devices business have stalled on valuation, according to people with knowledge of the matter.Pfizer has decided to resume talks with private equity firms to try for a more attractive price for the business, which it acquired in last year’s purchase of Hospira Inc., two of the people said, asking not to be identified because the deliberations are private. Pfizer may return to negotiate with Fresenius or keep the assets if no agreement is reached with the buyout firms, they said.Representatives for Pfizer and Fresenius declined to comment.The sale of the assets may fetch $1.5 billion to $2 billion, people familiar with the matter said in June. As of last month, Fresenius was the leading bidder to acquire the unit and was nearing an agreement with Pfizer, they said. Private equity firms including Pamplona Capital Management and U.K.-based Smiths Group Plc were among bidders for the unit earlier in the year, people said at the time, source BBERG. Fujifilm to Bid for Takeda’s Research Reagents Unit: Nikkei - The unit, in which Takeda has a roughly 70% stake, could fetch as much as 100b yen, Nikkei reports. Among those interested are Permira and other funds, as well as a major U.S. medical supplies co. GILD EU's CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for The CHMP adopted a new indication as follows: "Pre-exposure prophylaxis (PrEP): Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV 1 infection in adults at high risk GILD should target companies like TSRO says Guggenheim in a note GILD The CHMP has confirmed that the benefits of Gilead's Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects Huawei Technologies news that Samsung Electronics has filed a countersuit against Huawei Technologies, alleging infringement of its mobile technology patents as competition in the slowing smartphone market intensifies.The legal action comes after Huawei sued Samsung in

the US and China in May, seeking compensation for alleged infringement of intellectual property, including patents relating to cellular communications technology and software used by Samsung’s mobile phones. IMMY announced that positive results of a clinical study comparing the efficacy of its injected triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (Tri-Moxi-Vanc) Dropless Therapy formulation to drops commonly prescribed after cataract surgery now appear in the July issue of the Journal of Clinical Ophthalmology. In this prospective, randomized, subject-masked contralateral eye study, 25 subjects with uncomplicated cataract received either Tri-Moxi-Vanc intraocular solution injected transzonularly into the vitreous or a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (Pred-Moxi-Ketor) for 1 week, followed by prednisolone acetate and ketorolac tromethamine (Pred-Ketor) for 2 to 4 weeks. IPSEN EU's CHMP adopted a positive opinion recommending the granting of a marketing authorization to Ipsen for Cabometyx The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabometyx, intended for the treatment of advanced renal cell carcinoma (RCC). Cabometyx will be available as 20 mg, 40 mg and 60 mg film-coated tablets. ITEK expands intellectual property portfolio with combination patent The company announced that the United States Patent and Trademark Office issued a composition of matter patent for the combination of the company’s lead product candidate, trabodenoson, with a prostaglandin analog for the treatment of intraocular pressure (IOP) in patients with glaucoma US Patent number 9,370,530 (’530 patent) further strengthens the company’s patent estate for trabodenoson and adds composition of matter intellectual property protection for the combination or kit treatment option until 2031 JNJ CHMP adopted changes to the existing indications as follows: “IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). IMBRUVICA as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.” Mithra obtains FDA’s approbation for its Investigational New Drug for the phase III clinical trials of Estelle, Mithra says in statement. MRK announced efficacy and safety data in previously untreated adults with HIV-1 infection for the company’s investigational once-daily formulation of ISENTRESS (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg), from the ongoing Phase 3 pivotal trial called ONCEMRK. The data evaluating efficacy and safety at 48 weeks of therapy were presented as a late-breaking abstract at the 21st International AIDS Conference (AIDS 2016) being held in Durban, South Africa, from July 18-22, 2016. The study found that after 48 weeks of treatment, 1200 mg raltegravir (given as 2 x 600 mg once-daily) was statistically non-inferior (88.9 percent, 472/531) to the marketed formulation approved dose of ISENTRESS 400 mg twice-daily (88.3%, 235/266), each in combination therapy with TRUVADA (emtricitabine/tenofovir disoproxil fumarate); with a treatment difference [95% confidence interval] of 0.5 (-4.2, 5.2), as

assessed by the proportion of patients achieving less than 40 copies/mL of HIV RNA. Furthermore, the study showed comparable rates of reported drug-related clinical adverse events and rates of discontinuation between the two treatment groups. Based on these results from Week 48 of the ONCEMRK study, the European Medicines Agency (EMA) has accepted the file for the investigational once-daily formulation of ISENTRESS for review. Merck plans to submit applications for licensure in several countries, including the United States later this year. NICOX news that their partner VRX received a CRL from the FDA regarding its application for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. Concerns pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida, where some deficiencies were identified by the FDA Valeant intends to meet with the FDA as soon as possible NOVAN first patient has been dosed in SB208 for infections caused by dermatophytes, SB208 is an antifungal treatment, will have top line data in first half of 2017 for SB208 antifungal trials PFE FMS negotiations to acquire PFE pumps and devices business have stalled on valuation, according to people with knowledge of the matter.PFE has decided to resume talks with private equity firms to try for a more attractive price for the business, which it acquired in last year’s purchase of Hospira Inc., two of the people said, asking not to be identified because the deliberations are private. PFE may return to negotiate with Fresenius or keep the assets if no agreement is reached with the buyout firms, they said.Representatives for Pfizer and Fresenius declined to comment.The sale of the assets may fetch $1.5 billion to $2 billion, people familiar with the matter said in June. As of last month, Fresenius was the leading bidder to acquire the unit and was nearing an agreement with Pfizer, they said. Private equity firms including Pamplona Capital Management and U.K.-based Smiths Group Plc were among bidders for the unit earlier in the year, people said at the time, source BBERG. PFE EU's CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for Pfizer's Xalkori The CHMP adopted a new indication as follows: "Xalkori is indicated for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)." Recipharm: "Going forward I expect our growth-driving strategies, including executing on further acquisition opportunities, to continue to deliver. I’m confident that we will reach our long term growth targets set to 2020." ReNeuron Group publishes further key pre-clinical efficacy data with its hRPCs in TVST. A Phase I/II clinical trial has recently commenced in the US to evaluate the safety, tolerability and preliminary efficacy of the human retinal progenitor cells (hRPCs) in patients with the inherited blindness-causing disease, retinitis pigmentosa (RP). The paper, "Efficacy and safety of human retinal progenitor cells", has been published in the journal Translational Vision Science & Technology (TVST). The studies assessed the long-term efficacy and safety of ReNeuron's hRPCs using established pre-clinical rodent models and gave positive results. The hRPCs were well tolerated, safe and preserved retinal structure and vision up to six months post-injection in the studies. The cells also survived and integrated into both damaged and normal neural retina without adverse effects. Rhythm NEJM published PH II data on setmelanotide for pro opiomelanocortin deficiency a rare disorder, the data read favorably

Samsung Electronics has filed a countersuit against Huawei Technologies, alleging infringement of its mobile technology patents as competition in the slowing smartphone market intensifies.The legal action comes after Huawei sued Samsung in the US and China in May, seeking compensation for alleged infringement of intellectual property, including patents relating to cellular communications technology and software used by Samsung’s mobile phones. The world’s largest smartphone maker is one of the technology giants most under threat by the rapid rise of Huawei, which has become the third largest smartphone maker in the world. Huawei said it had not received a formal complaint yet but would defend itself if necessary. modernise its smartphone designs and applications.Huawei has cross-licensing agreements with Ericsson, Qualcomm, Nokia, Alcatel-Lucent and other telecoms technology makers.Samsung has also been locked in a bitter patent battle with Apple for more than five years, since the iPhone maker accused its largest rival of copying its designs. In 2012, a jury in California initially awarded Apple more than $1bn in damages, but the US Department of Justice entered the fray in June this year, recommending that the Supreme Court send the case back to lower courts to reassess the appropriate amount of damages awarded to Apple. Second Genome hire new president and CEO who is returning to the company from prior it Glen Nedwin is back having recently been at Taxon Biosciences which was also studying microbiome technology Statda activist shareholder AOC is questioning Stada's biosimilars business and wants the company to cut €100M of costs per year -- FAZ Separately, Stada said on its website yesterday that it doesn’t know about AOC having gained control of up to 30% of the company's voting rights, commenting on recent media reports. It adds that if AOC and parties acting in concert would have gained added voting rights and didn’t disclose this would breach transparency rules. Stada also says reports that AOC had presented STADA with a new list of candidates for the election of new Supervisory Board members are inaccurate. SYK FDS discloses Class I recall of Angiodynamics Soft Vu Omni Flush Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs. Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death. Takeda news that Fujifilm to Bid for Takeda’s Research Reagents Unit: Nikkei - The unit, in which Takeda has a roughly 70% stake, could fetch as much as 100b yen, Nikkei reports. Among those interested are Permira and other funds, as well as a major U.S. medical supplies company Targazyme enrolled the first patient in PH I/II TZ 01 for GVHD TBRA will be able to move its experimental non-alcoholic steatohepatitis (NASH) therapy, cenicriviroc, into Phase 3 testing “with very seamless design,” if upcoming Phase 2b data are positive, CEO says in phone interview.One-year liver biopsy data from Tobira’s Phase 2b “Centaur” study is expected in current quarter; TBRA targets starting Phase 3 in early 2017 Late-stage trials from other NASH therapy developers are currently seeking accelerated approval on surrogate endpoints that are measured at 72 weeks; if “Centaur” meets key secondary endpoint, TBRA may pursue talks with regulators to see if a one-year study would be sufficient instead of 72 weeks TBRA sees cenicriviroc as being potential “backbone” for

treatment of NASH; looking at combinations, including with company’s own candidate evogliptin (Phase 1 combo study targeted for this year), as well as other drugs in development for NASH Sees future of treatment similar to hepatitis C or HIV where combinations of two to three drugs with different mechanisms of action are needed to treat the disease On partnering, TBRA looking for firms in Asia-Pacific region for Phase 3 and commercialization; also looking at added partnership for cenicriviroc with or without evogliptin with a third agent for NASH: CEO Cenicriviroc has patent protection out until 2028 on original composition of matter; added patents out to 2035 TBRA sees cash resources sufficient through 2H17 (source BBERG) TSRO GILD should target companies like TSRO according to Guggenheim note UCB and AMGN filed Biologics License Application with FDA for romosozumab, a treatment of osteoporosis in postmenopausal women at increased risk of fracture. Application based on FRAME study; data to be presented at upcoming medical congress , possible BLA date Jul 24 2017 VRX partner to NICOX received a CRL from the FDA regarding its application for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. Concerns pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida, where some deficiencies were identified by the FDA Valeant intends to meet with the FDA as soon as possible YHOO VZ is the lead bidder for YHOO , and an announcement may come in the next few days, people familiar with the matter said, asking not to be named because the deliberations are private. Verizon and Yahoo are in one-on-one talks, one of the people said Deal hasn’t been finalized, may still fall apart, the people said Announcement unlikely to come today, they said VZ is the lead bidder for YHOO , and an announcement may come in the next few days, people familiar with the matter said, asking not to be named because the deliberations are private. Verizon and Yahoo are in one-on-one talks, one of the people said Deal hasn’t been finalized, may still fall apart, the people said Announcement unlikely to come today, they said XENE FDA grants orphan drug designation to Xenon Pharmaceuticals for flunarizine to treat hemiplegic migraine

Nature Chinese scientists are on the verge of being first in the world to inject people with cells modified using the CRISPR–Cas9 gene-editing technique.A team led by Lu You, an oncologist at Sichuan University’s West China Hospital in Chengdu, plans to start testing such cells in people with lung cancer next month. The clinical trial received ethical approval from the hospital's review board on July 6 2016. “It’s an exciting step forward,” says Carl June, a clinical researcher in immunotherapy at the University of Pennsylvania in Philadelphia. The Chinese trial will enrol patients who have metastatic non-small cell lung cancer and for whom chemotherapy, radiation therapy and other treatments have failed. “Treatment options are very limited,” says Lu. “This technique is of great promise in bringing benefits to patients, especially the cancer patients whom we treat every day.” Lu’s team will extract immune cells called T cells from the blood of the enrolled patients, and then use CRISPR–Cas9 technology — which pairs a molecular guide able to identify specific genetic sequences on a chromosome with an enzyme that can snip the chromosome at that spot — to knock out a gene in the cells. The gene encodes a protein called PD-1 that normally

acts as a check on the cell’s capacity to launch an immune response, to prevent it from attacking healthy cells. The gene-edited cells will then be multiplied in the lab and re-introduced into the patient’s bloodstream. The engineered cells will circulate and, the team hopes, home in on the cancer, says Lu. The planned US trial similarly intends to knock out the gene for PD-1, and it will also knock out a second gene and insert a third before the cells are re-introduced into the patient. Last year, the FDA approved for use against lung cancer two antibody-based therapies that block PD-1. But it is difficult to predict for any given patient to what extent these antibodies will block PD-1 and activate the immune response.By contrast, knocking out the gene blocks PD-1 with greater certainty, while multiplying the cells increases the chance of a response. “It will be much more powerful than the antibodies," says Timothy Chan, who does clinical research in immunotherapy at Memorial Sloan Kettering Cancer Center in New York City. It is well known that CRISPR can result in gene edits at the wrong place in the genome, with potentially harmful effects. Chengdu MedGenCell, a biotechnology company and a collaborator on the trial, will validate the cells to ensure that the correct genes are knocked out before the cells are re-introduced into the patients, says oncologist Lei Deng of West China Hospital, who is a member of Lu’s team. Because the technique targets T cells, which are involved in various kinds of immune responses, in a non-specific way, Chan worries that the approach might induce an excessive autoimmune response in which the cells would start attacking the gut, or adrenaline glands or other normal tissue. “All the T cells — everything will be active. That will be a concern,” says Chan. He suggests, instead, that the team take T cells from the site of the tumour, because they would already be specialized for attacking cancer. But Deng says that the lung-cancer tumours targeted by their trial are not easily accessible. He also says that the team is reassured by the FDA-approved antibody therapies, which did not show a high rate of autoimmune response. The phase I trial is designed foremost to test whether the approach is safe. It will examine the effects of three different dosage regimens on ten people, and, Deng says, the team plans to proceed slowly, increasing the dosage gradually and starting with just one patient, who will be monitored closely for side effects. But the researchers will also closely watch markers in the blood that would indicate that the treatment is working. Lu says that the review process, which took half a year, required that the team invest a lot of time and human resources, including close communication with the hospital’s internal review board (IRB). “There was a lot of back and forth,” he says. The NIH’s approval of the other CRISPR trial “strengthened ours and our IRB’s confidence in this study”, he adds. China has had a reputation for moving fast — sometimes too fast — with CRISPR, says Tetsuya Ishii, a bioethicist at Hokkaido University in Sapporo, Japan.According to Lu, his team was able to move fast because they are experienced with clinical trials of cancer treatments. June is not surprised that a Chinese group would jump out in front on a trial such as this: “China places a high priority on biomedical research,” he says.Ishii notes that if the clinical trial begins as planned, it would be the latest in a series of firsts for China in the field of CRISPR gene editing, including the first CRISPR-edited human embryos, and the first CRISPR-edited monkeys. “When it comes to gene editing, China goes first,” says Ishii.“I hope we are the first," says Lu. "And more importantly, I hope we can get positive data from the trial.”

NY Post

HUM exit could trip up Obamacare , hours before the lawsuit to block AET purchase of HUM was filed, HUM said it plans to leave 8 of the 19 exchanges it now operates because they are money losers AAPL sales of the Apple Watch tanked by more than half in the 2q 2016 and this is dragging down the entire smartwatch category AAPL sales in China could fall by 20% a report BIDU has predicted

Patent Docs AMGN and AGN Report Progress in Herceptin® Biosimilar Clinical Trial RHHBY In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human breast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science 244: 707-12 (1989). Following up on this discovery, Dr. Slamon and his collaborators found that a monoclonal antibody against the protein product of this gene, an epidermal growth factor receptor (EGFR) expressed on the cell surface of breast cancer cells, could be used to reduce proliferation of breast cancer cells in vitro and in vivo. This further discovery led to the development of one of the first therapeutic monoclonal antibody therapies, marketed by Genentech as Herceptin® (trastuzumab). Shepard et al., "Monoclonal antibody therapy of human cancer: Taking the HER2 protooncogene to the clinic," J. Clin. Immunol. 11: 117-27 (1991). Trastuzumab is approved for treatment of epidermal growth factor receptor (HER2)-positive primary and metastatic breast cancer. It is a "recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody." Today, Herceptin® is the 25th ranked pharmaceutical in the U.S. (February 2014), with $1.879 billion in sales in 2013. Thus, it is an attractive target for biosimilar competition, and Amgen and Allergan have teamed up to produce a biosimilar competitor. Yesterday the companies announced results from a Phase 3 clinical trial on their biosimilar drug, as reported by PRNewswire. AMGN Amgen The Phase 3 clinical study was performed to compare branded Herceptin® with Amgen/Allergan's biosimilar candidate (ABP 980). ABP 980 has the same amino acid sequence as Herceptin and is administered at the same pharmaceutical dosage form and strength as Herceptin. AGN Allergan The clinical study was a randomized, multicenter, double blind, and active-controlled (No. 20120283) for safety and efficacy. Participants were 725 adult female early breast cancer patients, with 364 being given ABP 980 and 361 given Herceptin®. All patients were HER2 positive. There were two phases of the trial: the neoadjuvant phase and the adjuvant phase. Patients in the neoadjuvant phase received chemotherapy (epirubicin and cyclophosphamide) every three weeks for four cycles. Thereafter, the patient pool was randomized with regard to Herceptin®/ABP 980 treatment which was administered with paclitaxel every three weeks for four cycles. Surgery was then performed 3-7 weeks after the last dose of the antibody products and the patients were then evaluated for pathologic complete response. In the adjuvant phase, post-surgical patients received either ABP 980 or Herceptin® every three weeks for up to one year from the first administration of the antibody in the neoadjuvant phase, with the species of administered antibody remaining consistent between the neoadjuvant and adjuvant phases for ABP 980, but with the species of antibody administered during the adjuvant phase being randomized during the adjuvant phase.

The study is not complete, and will not be completed until the last patient has completed the adjuvant phase. Clinical equivalence between ABP 980 and Herceptin® was evaluated based on the "confidence interval of the risk difference and risk ratio of the pathological complete response in breast tissue and axillary lymph nodes with prespecified equivalence margins" – i.e., comparing the results normalized by the extent of disease in individual patients. The top line results (the statistics that show whether clinical trial endpoints were met or not) reported "ruled out inferiority but could not rule out superiority" for ABP 980. The primary endpoint of the study had a "prespecified equivalence margin" of +\- 13%, and the observed upper end of the confidence interval was 13.4%. Observed adverse effects were comparable overall, with more serious adverse events reported for ABP 980 in the neoadjuvant phase compared with Herceptin®, but were unlikely to be related to the antibody. The incidence of adverse events were similar in the adjuvant phase of the study, and overall comparable immunogenicity was found between the reference product and the biosimilar. Genentech's patents on its Herceptin® product are scheduled to expire in 2019 and 2020.

Philadelphia Inquirer on ONCE ONCE Three years after spinning off from Children's Hospital of Philadelphia, gene-based drug developer Spark Therapeutics is planning an expansion that could take it out of the city. While Spark, currently based in University City, has some Philadelphia sites on its radar, it's also considering locations in New Jersey and Delaware, according to brokers at real estate services firm JLL, which is aiding the company in its search.The move to expand comes as Spark - among the most successful companies to emerge from research originating at Children's Hospital during its 160-year history - enjoys a string of clinical-testing successes that could yield one of the country's first approved gene therapies.Spark and partner Pfizer Inc. announced Thursday that the U.S. Food and Drug Administration had granted "breakthrough therapy" designation to a treatment being developed to fight hemophilia B.

July 21, 2016

My Informal takeover notes with attributions *health in green, tech in purple, energy/basic in blue, retail in maroon, financials in orange, miscellaneous in black

Jul 21 2016 BMRN and RHHBY coyness discussed in Betaville, a deal??

Jul 21 2016 ACAD: next highest probability buy out target within 2016. Disclosure: long ACAD on twtr

Jul 21 2016 RHHBY coyness in regards to BMRN buyout in Betaville

Jul 21 2016 GILD as takeover or merger of equal bait with MRK in Forbes

Jul 21 2016 MRK as takeover suitor or merger of equal partner for GILD in Forbes

Jul 21 2016 IONS as takeover bait for MRK in Forbes

Jul 21 2016 MRK as potential suitor for IONS in Forbes Jul 21 2016 P Pandora could wait and be worth more than the $ 15 LMCA supposed bid,discussed in Forbes

Jul 21 2016 LMCA P Pandora could wait and be worth more than the $ 15 LMCA supposed bid,discussed in Forbes

Jul 21 2016 BMRN news that RHHBY says that is unlikely to make a big acquisition in the near term.—and RHHBY CEO Severin Schwan declines to comment on speculation co. is interested in buying BioMarin at media event in Basel. RHHBY strategy remains to seek small, medium-sized deals Roche CEO: biotech valuations are too high even after recent market correction

Jul 21 2016 RHHBY says that is unlikely to make a big acquisition in the near term.—and RHHBY CEO Severin Schwan declines to comment on speculation co. is interested in buying BioMarin at media event in Basel. RHHBY strategy remains to seek small, medium-sized deals Roche CEO: biotech valuations are too high even after recent market correction Jul 21 2016 MON Is a White Knight poised to provide an “acceptable” offer for Monsanto (MON) and totally squelch Bayer AG’s (BAYN) unsolicited buyout bid? Rumors are swirling that Monsanto execs are talking with other interested parties to either sell a big stake or the entire company to gain a higher price for its assets. Monsanto has said unequivocally that it was “exploring other strategic options.”article in Forbes

Jul 21 2016 Actelion continues looking for smaller deals:You should not expect any big deal soon, smaller deals maybe,” CEO Clozel says in phone interview Co. may seek “very early-stage” assets, “in specialized, very rare diseases, specialty products; innovative drugs are rare, we have to be wide in our search:” Clozel Problem with large transactions is risk, not only cost; “we are not competitive with large companies that have big patent cliffs to fill and are ready to pay much higher prices than us and to take bigger risks:” Clozel Co. has not been approached for a deal It’s “highly unlikely” that Actelion will get Tracleer generics in the U.S. before year-end, CFO Muller says, bberg story

Jul 21 2016 Otsuka the prime suitor. Remember they already have $75 million invested in Ariad and another $75 committed to invest (Japan and all of Asia is a big market for both Pon and Brig). Yesterday volume was not a fluke. Something is going on and it's about to be announced., blurb on Investor Hub

Jul 21 2016 ARIA Otsuka the prime suitor. Remember they already have $75 million invested in Ariad and another $75 committed to invest (Japan and all of Asia is a big market for both Pon and Brig). Yesterday volume was not a fluke. Something is going on and it's about to be announced, blurb on Investor Hub Jul 21 2016 AmTRAN as next target for LeEcoMedia?, rumors have been buzzing these last few days about rumors of a potential acquisition by online video superstar LeEco (of the struggling low-cost TV brand Vizio, owned by Taiwan’s AmTRAN Technology, article on YCBB Jul 21 2016 LeEcoMedia AmTRAN as next target for LeEcoMedia?, rumors have been buzzing these last few days about rumors of a potential acquisition by online video superstar LeEco (of the struggling low-cost TV brand Vizio, owned by Taiwan’s AmTRAN Technology, article on YCBB

Jul 21 2016 BIIB has been much stingier than many of its rivals in those areas. It did say on Thursday's call that it's looking aggressively for deals and to bolster the pipeline. It's past time.

Jul 21 2016 Failure of 2 health insurer mergers is unlikely to thwart more efforts, Other insurers could follow suit by buying a PBM , a chain of urgent care centers or something similar to what UNH Optum unit has done in their blockbuilding, article in NY Times Biz Jul 20 2016 K shares fell sharply from speculative highs Wednesday after CNBC's David Faber said recent takeover rumors involving a Warren Buffett Berkshire Hathaway takeover of the company have no merit.Faber said the rumors, in addition to sprouting up on the recent WhiteWave/Danone deal, can be traced back to a hedge fund that tracks airplane tail numbers. The hedge fund presented data on airplane activity between Omaha (Warren Buffet HQ), Battle Creek (Kellogg HQ), Chicago (Kraft Heinz/3G), and Southern California (Charlie Munger and Director).While interesting, Faber said, after talking to people that would "absolutely" know, they indicate "there is nothing going on here."

Jul 20 2016 JNJ in terms of mergers and acquisitions, Caruso said, “Our strategy in pharma is licensing and collaborations and not major acquisitions. That doesn’t mean we’re not going to do one.” article on Biospace

Betaville RHHBY said to have rekindled interest in BioMarin Pharmaceutical - sources I see Bloomberg was today badgering Dr Severin Schwan, the Roche chief executive, into providing a denial to my BioMarin story from a few weeks ago.According to the Bloomberg story I read today, Dr Schwan said Roche was looking at small to medium-sized acquisitions although he believes biotech valuations are "too high" even after the recent market correction.But when the Bloomberg hack tried to elicit a denial or confirmation by asking specifically about Roche's interest in BioMarin Dr Schwan declined to comment. I wonder why.

New health & related events to add Understanding Long-Term Response Rates and Treatment Dilemmas in Diabetic Macular Edema, sponsored by Evolve Medical – San Fran Aug 11 2016 APDA expert perspectives on how to take an active role in the treatment plan of people with Parkinson’s disease (PD). Assistant Professor Department of Neurology Emory University School of Medicine Atlanta, GA Harrison Walker, MD Associate Professor of Neurology Medical Director for Surgical Movement Disorders University of Alabama at Birmingham Birmingham, ALCo specific events to add non health This program is designed to help people with PD, family members and care partners Aug 17 2016 DMPI at the EANO annual meeting in October DelMar Pharmaceuticals announces that it will present an abstract at the 12th Meeting of the European Association of Neuro-Oncology (EANO) taking place in Mannheim, Germany from Oct 12-16 2016 Eye for Pharma – ALMIRALL JNJ LEO MRK SNY TEVA NVS VIIV Barcelona Mar 14-17 2017 SIGA PIP court hearing to consider the Joint Motion is scheduled to be held before the Bankruptcy Court on Aug 15 2016 PIP SIGA court hearing to consider the Joint Motion is scheduled to be held before the Bankruptcy Court on Aug 15 2016 Ono Pharmaceutical Co Ltd R&D Presentation Sep 23 2016 QGEN Qiagen NV Private Investor Day Sep 23 2016

UDG Healthcare PLC Capital Markets Day Sep 27 2016 WDAY Workday Inc Analyst Sep 27 2016 MRK BLA for Bezlotoxumab pdufa date is extended from Jul 23 2016 to Oct 23 2016 KR The Kroger Co Investor Conference Nov 1-2 2016 PHG Koninklijke Philips NV Capital Markets Day Nov 4 2016 Bionomics Ltd BNO.AX and Merck MRK Annual Symposium Nov 7 2016 MRK and Bionomics Ltd BNO.AX Annual Symposium Nov 7 2016 SHPG Investor Day Nov 10 2016 ERIC LM Ericsson Capital Markets Day Nov 10 2016 NOKIA Nokia Corp Capital Markets Day Nov 15 2016 LRCX Lam Research Corp Investor and Analyst Meeting Nov 16 2016 SNY Sanofi SA Individual Shareholders Meeting – Tours Nov 28 2016 United Medical Systems International AG UMS.FUMS Analyst Conference 2016/2017 Nov 30 2016 JCI Johnson Controls Inc Corporate Analyst Meeting Dec 5 2016 DEO Diageo PLC Brunchtime Call with the Presidents: North America Dec 6 2016 L'Oreal SA Individual Shareholders Meeting – Toulouse Dec 8 2016 SNY Sanofi Individual Shareholders Meeting – Reims Dec 8 2016 CNC Centene Corp 2017 Financial Guidance and Investor Day Dec 15 2016 PBYI possible pdufa date for PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy Pdufa could be in one year Jul 21 2017

New Sell side health conferences to add Pareto Securities Healthcare Seminar - Stockholm, SE Sep 1 2016 Leerink Partners Rare Disease & IO Roundtable Series - New York, NY Sep 28-29 2016 Bryan Garnier European Healthcare Conference - Paris, FR Nov 15 2016

New Sell side conferences that could be related to health and tech to add Mitsubishi UFJ Securities Technology Tour - Seattle - Seattle, WA Aug 15-18 2016 Mitsubishi UFJ Securities Technology Tour - Silicon Valley - CA Aug 15-18 2016 Mitsubishi UFJ Securities Technology Tour - SF - San Francisco, CA Aug 15-18 2016 Barclays Select European Media and Telecom Forum - London, GB Sep 6 2016 Barclays Disruptive Mobility Conference - London, GB Sep 8 2016 UBS Swiss Day - Paris, FR Sep 8 2016 Maxim Group Inaugural Israel Day - New York, NY Sep 14 2016 Mitsubishi UFJ Securities Property REIT Conference - New York, NY Sep 27 2016 Goldman Sachs Leveraged Finance Conference - London, GB Sep 27 2016 SeeThruEquity Investor Conference - New York, NY Oct 17 2016 Sanford C Bernstein Technology Innovation Summit - New York, NY Nov 7 2016 Houlihan Lokey Alternative Asset Valuation Symposium - New York, NY Nov 9 2016 Morgan Stanley European TMT Conference - Barcelona, ES Nov 15-16 2016 Natixis Midcap Conference - Paris, FR Nov 22 2016 Equita Payments Conference - Milan, IT Nov 24 2016 Exane Midcap Forum - London, GB Nov 29 2016

Citi ASEAN Stars of the Next Decade: Multi-sector champions - HK - HK, HK Nov 29 2016

New Co Specific events to add non health SAP SAP SE Q2 Debt Investors Update Call Jul 26 2016 PII Polaris Industries Inc Analyst/Investor Meeting Jul 26 2016 PFG Principal Financial Group Inc at RBC Capital Markets Investor Event Sep 12 2016 RMBS Rambus Inc Analyst Day Sep 20 2016 WDAY Workday Inc Analyst Sep 27 2016 Yit Oyj Capital Markets Day Sep 29 2016 ABB Ltd Capital Markets Day Oct 4 2016 Arrow Global Group PLC Capital Markets Day Oct 11 2016 JHX.AX James Hardie Industries PLC New Zealand Tour for Analysts and Investors Oct 21 2016 Valmet Corp Q3 Presentation for Institutional Investors Hosted by Danske Bank Oct 28 2016 KR Kroger Co Investor Conference Nov 1 -2 2016 GLEN 3Q 2016 Glencore PLC Production Volume Nov 3 2016 PHG Koninklijke Philips NV Capital Markets Day Nov 4 2016 Shimizu Corp Company Visit Nov 5 2016 ENEL.MI Enel SpA Strategic Plan Presentation Nov 7 2017 KESBV.HE Kesko Oyj Investors' Evening – Oulu Nov 7 2016 Aeroports De Paris SA Site Visit to Paris-Charles de Gaulle Airport Nov 8 2016 Felda Global Ventures Holdings Bhd Site Visit - Kuala Lumpur Nov 8-9 2016 RDS/A Royal Dutch Shell PLC Investor Day Nov 8 2016 Santos Brasil Participacoes SA Public Meeting with Analysts Nov 9 2016 ERIC LM Ericsson Capital Markets Day Nov 10 2016 GXI.DE Gerresheimer AG Corporate Presentation To Private Investors Nov 10 2016 MET Metlife Inc Corporate Investor Day Nov 10 2016 TSE Trinseo SA Investor Day Nov 11 2016 Kobe Steel Ltd Factory Tour for Shareholders Nov 13-14 2016 NOKIA Nokia Corp Capital Markets Day Nov 15 2016 Atlas Copco AB Capital Markets Day Nov 15 2016 PRU.L Prudential PLC Investor Conference Nov 15-16 2016 Safran SA Site Visit Nov 15 2016 Bpost SA Capital Markets Day Nov 15 2016 ASSA.ST Assa Abloy AB Capital Markets Day Nov 16 2016 DNB ASA Capital Markets Day 2016 Nov 16 2016 Fortum Oyj Capital Markets Day Nov 16 2016 PFG Principal Financial Group Inc Investor Day Nov 16 2016 LRCX Lam Research Corp Investor and Analyst Meeting Nov 16 2016 Stora Enso Oyj Capital Markets Day Nov 17 2016 ELET6.SA Centrais Eletricas Brasileiras SA LATIBEX – Madrid Nov 17-18 2016 Kongsberg Gruppen ASA Capital Markets Day Nov 17 2016 MRV Engenharia e Participacoes SA investors meetings – Apimec Nov 17 2017 Talanx AG Capital Markets Nov 17-18 2016 TVPT Travelport Worldwide Ltd Investor Day Nov 17 2016

Zurich Insurance Group AG Investor Day Nov 17 2016 RJF Raymond James Financial Inc Oct 2016 Operating Data Release Nov 22 2016 SAF.PA Safran SA Site Visit Nov 22 2016 G.MI Assicurazioni Generali SpA Investor Day Nov 23 2016 KESBV.HE Kesko Oyj Investors' Evening Nov 23 2016 RAND.AS Randstad Holding NV Capital Markets Day Nov 23 2016 TERI3.SA Tereos Internacional SA Public Meeting with Analysts and Investors Nov 24 2016 Compagnie de Saint Gobain SA Company Visit Nov 25 2016 Kesko Oyj Investors' Evening – Helsinki Nov 28 2016 Outokumpu Oyj Capital Markets Day Nov 29 2016 Allianz SE Capital Markets Day 2016 in Munich Nov 30 2016 Wendel SA Investor Day Dec 1 2016 NHY Norsk Hydro ASA Capital Markets Day Dec 1-2 2016 PGS.OL Petroleum Geo Services ASA Capital Markets Day Dec 1 2016 TCSA3.SA Tecnisa SA Public Meeting with Analysts and Investors Dec 1 2016 GOL Gol Linhas Aereas Inteligentes SA Public Meeting-NY Dec 5 2016 HYPE3.SA Hypermarcas SA Public Meeting with Analysts Dec 5 2016 JCI Johnson Controls Inc Corporate Analyst Meeting Dec 5 2016 DEO Diageo PLC Brunchtime Call with the Presidents: North America Dec 6 2016 HGTX3.SA Cia Hering Analyst Public Meeting Dec 6 2016 LOW Lowe's Companies Inc Analyst and Investor Conference Dec 7 2016 AGN.AS Aegon NV Analyst & Investor Conference Dec 8 2016 BEN November 2016 Franklin Resources Inc AUM Dec 8 2016 FLRY3.SA Fleury SA Corporate Public meeting with Analysts Dec 8 2016 LINX3.SA Linx SA Corporate Public Meeting with Analysts Dec 8 2016 GFA Gafisa SA Public Meeting with Analysts - Gafisa Day Dec 8 2016 AXA SA Shareholders' Information Meeting – Toulouse Dec 8 2016 Outotec Oyj CEO's Q&A Teleconference Dec 13 2016 MTX.DE MTU Aero Engines AG Investor & Analyst Day 2016 Dec 14 2016 GCHE.MZ Gruppa Cherkizovo PAO CEO Annual Breakfast for Analysts Dec 15 2016 ICA.ST ICA Gruppen AB Capital Markets Day Dec 15 2016 CCPR3.SA Cyrela Commercial Properties SA Empreendimentos e Participacoes Open Meeting with Stakeholders Dec 16 2016 BBRK3.SA Brasil Brokers Participacoes Sa Corporate Public Meeting with Investors and Analysts Dec 16 2016 RJF Raymond James Financial Inc November 2016 Operating Data Release Dec 21 2016

Forbes GILD and IONS as takeover candidates Todd Hagopian who runs Marketocracy in March, 2011 is buying because he believes the biotech industry is ripe for acquisitions as large, cash-flow rich drug companies look for promising new products. Todd started his Biotech fund. His returns have averaged 28.12% since then, which compares nicely to the S&P 500’s 11.87% return over the same period. Over the last five and three year periods, he did better than the top U.S. Equity fund manager MRK by combining their own pipeline with GILD’s, along with expanding into the Hepatitis B market that GILD is pursuing, this is the type of game-changing acquisition that MRK needs.

While GILD’s growth rate is not too impressive, MRK could dramatically lower the overhead if the two were to merge, and the bottom line would increase at a much faster rate than either of the two companies could muster on their own. This would almost be a merger of equals, with GILD likely demanding about $150 Billion, which would still be a bargain deal for MRK. GILD generates over $10 Billion per year in free cash flow and is trading at only 6x 2018 earnings, which makes the company one of the best bargains in the Biotech field. IONS If MRK sticks with the smaller acquisitions, Ionis Pharmaceuticals (IONS) would make a nice choice. IONS has 33 products in its drug pipeline. MRK would instantly inherit nine Phase 3 drugs, twelve Phase 2 drugs, six Phase 1 drugs, and six Pre-Clinical drugs. This acquisition would instantly put MRK deeper into the profitable Hepatitis C, Hepatitis B, and Oncology spaces. The price tag on this would likely be around $4 Billion. Hagopian: In my opinion, if Gilead is not purchased by a major pharma company like MRK, Gilead needs to make an acquisition. Wall Street analysts believe that GILD is far too invested in the Hepatitis C field, where they will struggle to get much larger. While I believe that their advancements in Hepatitis B will pay enormous dividends, the analysts would like to see them reinvest their impressive cash flow into the oncology space to improve their long term growth rate, and mitigate the risk of their position in the Hepatitis C market.

Forbes on Pandora Pandora (P) There have been whispers in the music industry for some time now that streaming internet radio service Pandora might be sold, but it appears that today is not the day for such a transaction. According to a report by the WSJ, Liberty Media LMCA approached Pandora with an offer, but it was almost immediately shut down, and no sale is on the horizon. According to the article, Liberty Media CEO Greg Maffei offered $15 per share of the publicly traded company, which adds up to about $3.4 billion. That was apparently not enough for Pandora’s board, which quickly turned down the offer, which it deemed to be too low. Apparently, those running the show at the California-based streaming giant believe the company to be worth at least $20 per share. $5 more per share might not necessarily sound like a lot of money when billions are on the table, but it actually is a lot of money when there are several hundred thousand out there, and when profits have been hard to come by lately. This story isn’t entirely surprising, as Pandora has been struggling financially recently, and though this sale didn’t work out, it is entirely possible that the company may change ownership at some point in the near future. Though it remains one of the most popular streaming options in the world, Pandora, like many other companies competing in the streaming music world, is losing money year after year. In just one quarter of 2016, Pandora posted a loss of over $100 million. That’s a bit better than some of its notable streaming rivals, but it certainly doesn’t put the firm in a comfortable position. It is possible that Pandora is waiting for a slightly better offer, and those in charge could be smart in doing so. While the company isn’t consistently profitable, it does have a massive audience, and there is plenty of room for growth. Pandora has upwards of 100 million active users, and streaming is becoming more popular every day. As the internet radio pioneer prepares to delve into the on-demand category and truly take on Spotify, anything is possible, and that makes Pandora potentially worth quite a bit of money.

FT Lex

ERIC stock has some attractions it has significant revenues from patent licensing and a 4% yield, but ERIC share price has barely changed since Hans Vestberg started in 2010, expenses are too high and cost of goods has hardly budged in 5 years.For Vestberg, a back career may be suitable MSFT tinted windows , article on the growing outrage about non GAAP reporting and MSFT biggest adjustment affects revenues swelling them $ 2 bil , this is unusual but GAAP rules are set to change in 2017 and MSFT non GAAP heresy is tomorrow’s unorthodoxy UN bid for Dollar Shave is discussed, expect UN to go further, beyond aftershave in a bid to cut out retailers and take on AMZN MCD Japan's Pikachew, with the MCD Holdings Japan shares trading about half the EV to sales multiple of the US parent, a Pokemon upside option could complete a very happy meal

NY Times Failure of 2 health insurer mergers is unlikely to thwart more efforts, Other insurers could follow suit by buying a PBM , a chain of urgent care centers or something similar to what UNH Optum unit has done in their blockbuilding

Prohost the excellent newsletter Positive commentary on AMGN GILD ILMN SGEN

Real Clear Health headlines Is an Alzheimer's Vaccine on the Horizon? - Emily Gurnon, Next Avenue Bug Startup Just Raised $100 Million to Fight Hunger - Primack, Fortune China Investigating Data Leak and Swindling of HIV Patients - Kan, NYT Cruise Time? Norovirus Time. - NewsWorks Follow us: @RealClearHealth on Twitter | RealClearHealth on Facebook Young Internist Rallies Docs Against Trump - Shannon Firth, MedPageToday. The Middlemen in Higher Drug Prices - Steve Pociask, RealClearHealth The Role of Mental Illness in Extremism, Terror - Maria Cheng, AP Obamacare's Other Success, Under Threat - Bloomberg View Most Insurers Lost Money in ACA's First Year: Study - Sarah Ferris, Hill States Can Tailor - and Trim - Addiction Programs - Sheryl Strasser, Conv. Opioid Abusers Miss Out on Anti-Addiction Drug - Dennis Thompson, HD The Real Reason for More Heroin Users - Keith Humphreys, Wonkblog New Funding to Help Dental Care Clinics - Zhai Yun Tan, CHL Anti-Abortion Forces Regroup After Ct.'s Decision - Julie Rovner, KHN VA Hospitals Compare Favorably to Non-VA Centers - Robert Preidt, HD The Costliest Outpatient Drugs for Medicaid - Ed Silverman, Pharmalot Stop the Privatization of Health Data - Wilbanks & Topol, Nature RNC Ignores Science, Embraces Pseudoscience -

BioWatch news on EVOK We recently published terse commentary regarding the failure of EVK-001 to treat female diabetic gastroparesis. In recent press releases, Evoke pointed to an alleged bifurcation of results: 28 of 41 sites reported statistically significant benefit in favor of EVK-001 (p=0.006) 13 of 41 sites reported statistically significant benefit in favor of Placebo (p=0.002).

Evoke management then announced an at-the-market offering for $4.5M, to pay for further analyses of the data and meet with the FDA We don’t think the FDA will approve on this data. The meeting will simply help describe the updated approval path for EVK-001. What are some possible problems?The drug works only in females. Actually, this is true with other approved drugs for gastrointestinal disorders. Females are also far more likely to have diabetic gastroparesis. The underlying reason is hypothesized to relate to female hormone levels The rest of the analyses will carefully examine systematic differences in recruiting and especially diagnostics. This calls for an external audit that requires outside consultants to get involved.For our own lessons learned, we are curious about the aftermath. We haven’t changed our position; Evoke Pharma is in a brutal place: little cash, failed results, and a one-hit wonder.Our interest in Evoke was clear: nasal metoclopramide was demonstrated to have superior efficacy to its already approved oral formulation. Earlier Pros and Cons We liked the streamlined development utilizing the 505(b)2 pathway. We liked 24 clinical trials that confirm the safety and efficacy of the intranasal formulations. We liked that it met physician and patient needs. We liked its profile for reimbursement and the hospital formulary. We liked the management commitment to capital efficiency. But on the CON side, we stated the following: No pivotal trial is really a slam dunk. This area of research often has large placebo effects. We are also a bit worried (but only a bit), about any additional side effects popping from an intranasal route of administration. Prior studies have tested safety at up to 80 mg intranasal doses; the pivotal trial is only looking at 10 mg doses. This is a one-shot.Except for its wonderful safety, we hoped this wouldn’t be its epitaph. We think it will. We look forward to seeing the data. We also saw why we are biased against one-shot companies: one drug, one indication. In Evoke, the hypothesized risk lined up well, but after the smoke clears and the management has received its results, we’ll do a final round-up with our beta (testers) customers.

HBV Advocate CMS has released a proposed decision memo for adding hepatitis B screening as a covered Medicare preventive service. CMS is proposing to cover hepatitis B screening at no cost to Medicare beneficiaries who are at high risk as defined by the United States Preventive Services Task Force. To be covered by Medicare, the test would need to be ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting and performed by an eligible Medicare provider. CMS is now accepting public comments in response to its proposed decision. The deadline to submit comments is August 6, 2016.

Broker meetings in health next week Jul 25 NVS-Berenberg- London Jul 26 AXON - Jefferies-Toronto, Canada

PTLA -Morgan Stanley TRVN- Wedbush AEZS - Maxim-New York, NY Jul 28 AEZS - Maxim-New York, NY

Broker meetings non health next week Jul 25 ASML - Pacific Crest-Boston MANU - Jefferies-Beijing/Shanghai PLD - JPMorgan-Jersey City/New York SBUX - Jefferies-San Francisco, CA SPTN - Jefferies-Boston, MA TRV - Sandler O’Neill-Midwest Jul 26 ASML - Pacific Crest-New York, NY GPC - Sterne Agee CRT with Genuine Parts CEO, CFO and IR in Texas GSVC - Barrington-Detroit, MI SBUX - Jefferies-San Francisco, CA TRV - Sandler O’Neill-Midwest Jul 27 HELE - Jefferies-New York, NY JBLU - Evercore ISI-Boston, MA Jul 28 AKAM CEO and IR -Morgan Stanley San Fran Jul 28 2016 BNS - Canaccord-Montreal, Canada DOX - Oppenheimer -Boston, MA JBLU-Evercore – Boston Jul 28 2016 SYNT - Barrington-Richmond, VA Jul 29 BP - Jefferies-New York, NY

Forbes Gene Marcial MON Is a White Knight poised to provide an “acceptable” offer for Monsanto (MON) and totally squelch Bayer’s unsolicited buyout bid? Rumors are swirling that Monsanto execs are talking with other interested parties to either sell a big stake or the entire company to gain a higher price for its assets. Monsanto has said unequivocally that it was “exploring other strategic options.”Monsanto, which had rejected Bayer’s surprise initial buyout offer on May 24, 2016, of $122 a share, or about $62 billion, once again spurned, on July 19, a modestly improved buyout bid by Bayer of $125 a share. The latest offer, was unanimously rejected by the Monsanto board of directors as “financially inadequate, and insufficient to insure deal certainty.”Although Monsanto indicated that it wasn’t closing the door for further talks with Germany’s Bayer, a global pharmaceutical and healthcare company, it has also continued discussions with other companies, according to close watchers of Monsanto. That in part encouraged at least one big shareholder of Bayer to launch a “hostile” takeover campaign in light of Monsanto’s repeated rejection of its offer.

BioCFA.com on BSGM and NVRO mentioned. BSGM BioSig Technologies) leading product is d PURE EP, a Class II medical device that marries together proprietary hardware and advanced signal processing software to improve the signal clarity of cardiac data during an electrophysiology study. The enhanced real-time data provides the electrophysiologists with a better diagnostic tool, leading to improved clinical outcomes through maximized ablation efficacy, shorter surgery times, and reduced need for repeat procedures. BioSig's burgeoning relationship with Mayo Clinic is something that I believe is incredibly important regarding product validation and establishes a precedent for future success. From an operational standpoint, Nevro looks to be about three years ahead of BioSig. In this regard, the $2.3 billion market value for Nevro versus the $27 million valuation for BioSig seems a discrepancy. Yes, Nervo's Senza® targets the enormous chronic back pain market, but BioSig's PURE EP targets a very large electrophysiology market as well. According to Global Industry Analysis, the electrophysiology device market will grow at a 12.1% compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019, making it one of the fastest growing medical device segments (11). Accordingly, the number of catheter ablation procedures done in the U.S. is also expected to see accelerating growth (12). According to Health Research International, the number of catheter ablation procedures on a global basis is projected to reach 160,000 in 2017. In my valuation model published last month, I forecasted PURE EP generating $615 million in cumulative revenue over the decade following approval, with approval likely during the second half of 2017. Peer-comparable valuation analysis suggests that BioSig is worth 7x its current valuation. Nevro is worth 85x BioSig's current valuation. Last week, BioSig published a shareholder letter highlighting some of the company's recent developments, including a $4.5 million private placement, expanding the relationship with Mayo Clinic, and preparing for the commercial launch of PURE EP in 2017. It's a good read for anyone interested in the story. In mid-August, BioSig will participate at the 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC2016). EMBC2016 will take place in Orlando, FL with an overall theme of “Empowering Individual Healthcare Decisions through Technology.” Sessions include diverse topics from cutting-edge biomedical and healthcare technology research and development to clinical applications and biomedical education. BioSig will deliver an oral presentation entitled, “Enhanced Electrophysiology Recording System” and recent findings from the preclinical trials at Mayo Clinic with a poster session to follow. Presentation of this data could act as an excellent catalyst for the shares. Importantly, BioSig and Mayo have an additional nine studies planned between today and the second quarter 2017. Above I've outlined why I believe the relationship with Mayo provides confidence and credibility to the story. Nevro is a perfect example of a Mayo-backed success and clearly the roadmap for where BioSig could be heading over the next few years.

Health News AAPL analysts are saying that MacBook Pro 2016 may likely be released in October and Apple has been paying a price as MacBook Pro sales have reportedly gone down following the delay. Consumers and observers in the industry alike have both been in the dark as to the reasons for Apple's delay to release MacBook Pro 2016. Apple's competitors gain in the process since most have already shipped their latest products.MacBook’s sale has gone done from 4.8 million in

2015 to 4.4 million this year. It adds that the US market also showed a slight decrease from 2 million last year to a recorded 1.9 of the same period this year, Parental Herald reported. Many say that it's the timeframe of the release. Rumors have it that Apple has set the release of the upcoming MacBook Pro at the fourth quarter of 2016, which could be either September or October.iTech Post claimed that Apple may also want to clean-up stores and sell the older models before introducing MacBook Pro 2016 to the market.The third rumor suggested that Apple is still undergoing some physical changes in the upcoming laptop, considering the removal of headphone jack port and replacing it with Consumers have their eyes on MacBook Pro 2016 as it promises features to die for. Apple says it will have a slimmer body and weighs lighter than most, giving convenience as one carries it anywhere. MacBook Pro 2016 also features Thunderbolt 3 port, FaceTime HD camera, dual mics and stereo speakers. Apple is reportedly installing more creative apps including Pages, Numbers, iMovie and more. (article in the Counselheal.com) ABAX share Repurchase program Abaxis' board has approved a $30M increase to its existing share repurchase program, to a total of $54M. Actelion continues looking for smaller deals:You should not expect any big deal soon, smaller deals maybe,” CEO Clozel says in phone intv. Co. may seek “very early-stage” assets, “in specialized, very rare diseases, specialty products; innovative drugs are rare, we have to be wide in our search:” Clozel Problem with large transactions is risk, not only cost; “we are not competitive with large companies that have big patent cliffs to fill and are ready to pay much higher prices than us and to take bigger risks:” Clozel Co. has not been approached for a deal It’s “highly unlikely” that Actelion will get Tracleer generics in the U.S. before year-end, CFO Muller says ADXS axalimogene filolisbac gets FDA fast track designation as an adjuvant therapy for high-risk locally advanced cervical cancer patients .ADXS AXAL receives Fast Track designation by the FDA as adjuvant therapy for High-Risk locally advanced cervical cancer patients ADXS announced that the FDA has designated the company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this underserved population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA. ADMP terminates license agreement for Adamis’ Epinephrine Pre-filled Syringe Adamis Pharmaceuticals announced that it has received notice from AGN Allergan’s subsidiary, Watson Laboratories, Inc. , that Watson has decided to terminate the previously announced license agreement to commercialize Adamis’ Epinephrine Pre-filled Syringe product candidate for the emergency treatment of anaphylaxis in the United States. This decision follows Adamis’ receipt from the FDA of a Complete Response Letter in June and precedes the deadline for Watson to terminate in order to avoid a significant nonrefundable upfront fee and milestone payment. Adamis notes that it is planning to meet with the FDA this quarter and is still tracking to resubmit its updated NDA by the end of this year AET after more than a year of scrutiny, the U.S. Justice Department filed requests for preliminary injunctions Thursday to block the two health insurance deals led by Aetna and Anthem that would shrink the number of national carriers from five to three if allowed to proceed.For the past year, Aetna has pursued its $37 billion acquisition of Humana to bolster its Medicare Advantage business. Anthem's $53 billion bid for Cigna Corp. would consolidate

health insurance administration offered to employers.But federal and state regulators officially sued to block those deals, citing reduced competition and potential harm to American consumers.The Justice Department will stream their announcement at 11 a.m. EDT. AET and HUM respond to DoJ lawsuit Aetna (AET) and Humana Inc. (HUM) announced plans to vigorously defend the companies’ pending merger in response to a U.S. Department of Justice (DOJ) lawsuit seeking to block the transaction. The companies believe that combined company is in the best interest of consumers, particularly seniors seeking affordable, high-quality Medicare Advantage (MA) plans. They add that to date, regulators in 18 of 20 states where change of control applications are required have approved the transaction, with remaining reviews underway. Any perceived competition concerns can be addressed through divestitures. Though the companies do not believe divestitures are necessary, significant and well-established industry players have already submitted bids for MA assets in certain states that regulators may require to be divested AGN FDA grants tentative approval to Actavis' generic Diclegis According to FDA website, on 19-Jul the agency granted Tentative Approval to Actavis' (AGN) ANDA for doxylamine succinate; pyridoxine hydrochloride. AITP files to withdraw IPO Advanced Inhalation Therapies hereby requests the immediate withdrawal of the its Registration Statement on Form F-1 (File No. 333- 206557), together with all exhibits and amendments thereto. ALK-Abello Site FDA said it documented deviations from current CGMP requirements during inspection of ALK-Abello plant in Horsholm, Denmark. FDA cites expired components in the manufacturing of Pharmalgen Says company gave insufficient detail in response and further information, discussion with ALK-Abello is necessary AMGN to pay Connecticut State $95M to settle class action suit which involved securities bought between 2004-2007. AMGN and AZN announce top-line results from phase 3 study evaluating ABP 980 compared with Trastuzumab The companies have announced results from a Phase 3 study evaluating efficacy and safety of ABP 980 compared with trastuzumab (Herceptin, ROG.SW) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. The results ruled out inferiority compared to trastuzumab but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR). The primary endpoint had a prespecified equivalence margin of +/- 13% and the observed upper end of the confidence interval was 13.4%. Overall, adverse events were comparable between ABP 980 and trastuzumab. In the neoadjuvant phase of the study, which included chemotherapy, there were more serious adverse events reported in the ABP 980 group, the majority of which were reported by the investigators as unlikely related to investigational product. In the adjuvant phase of the study, which did not include chemotherapy, serious adverse events were comparable between treatment groups. The overall results also showed comparable immunogenicity. ANTM issues statement on DoJ action Today’s action by the Department of Justice (DOJ) is an unfortunate and misguided step backwards for access to affordable healthcare for America. Access to health insurance saves lives, improves health and reduces the cost of care for all Americans. The DOJ’s action is based on a flawed analysis and misunderstanding of the dynamic, competitive and highly regulated healthcare landscape and is inconsistent with the way that the DOJ has reviewed past healthcare transactions. Anthem has an unwavering

commitment to enhancing access to affordable healthcare and the benefits and efficiencies from its merger with Cigna (CI) is one way that Anthem will continue its mission of improving consumer choice, quality and affordability. Anthem is fully committed to challenging the DOJ’s decision in court but will remain receptive to any efforts to reach a settlement with the DOJ that will allow us to complete the transaction and deliver its benefits at a critical time when American consumers are seeking high quality healthcare services with greater value at less ANTM after more than a year of scrutiny, the U.S. Justice Department filed requests for preliminary injunctions Thursday to block the two health insurance deals led by Aetna and Anthem that would shrink the number of national carriers from five to three if allowed to proceed.For the past year, Aetna has pursued its $37 billion acquisition of Humana to bolster its Medicare Advantage business. Anthem's $53 billion bid for Cigna Corp. would consolidate health insurance administration offered to employers.But federal and state regulators officially sued to block those deals, citing reduced competition and potential harm to American consumers.The Justice Department will stream their announcement at 11 a.m. EDT. ARAY announced preliminary results from a prospective, phase II trial evaluating once-daily accelerated partial breast irradiation (APBI) in patients treated with the TomoTherapy System. The study, published in the June issue of the peer-reviewed AntiCancer Research, International Journal of Cancer Research and Treatment, reported no recurrence of cancer in the treated breast at median follow-up of 34 months. Additionally, more than 95% of patients and their physicians rated cosmesis -- preservation of the normal appearance of the breast -- as good/excellent. The study titled, 'Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical TomoTherapy,' provides results for 111 patients treated with APBI following lumpectomy. It also demonstrated that: Delivering the dose once a day over 10 days (others studies use 10 fractions twice-daily) could be a contributing factor to better cosmetic outcomes and lower toxicity. This is made possible because of the integrated image guidance of the TomoTherapy System and its excellent dose homogeneity; Patient compliance was remarkable as all patients completed the treatment without interruption; Treatments were very well tolerated with minimal acute or late side effects. AZN announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant to current antibiotics commonly used for serious infections, such as carbapenems and polymyxins, including colistin. The REPROVE trial assessed the efficacy of Zavicefta (ceftazidime -avibactam) compared with meropenem in the treatment of adult patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). Zavicefta met the primary objective of statistical non -inferiority compared to meropenem at the test of cure visit (day 21 from randomisation). All-cause mortality rate at day 28 from randomisation was also similar in the two groups. Safety observed in the trial was consistent with the known safety profiles of both antibiotics. Full results from REPROVE are expected to be presented at future scientific meetings. AZN Senators Susan Collins, R-Maine, and Claire McCaskill, D-Mo., send letter to AZN seeking information on the co’s position that generic competitors to Crestor should be delayed from entering market, according to statement. “While we understand the important role of labeling, we are concerned that AstraZeneca’s interpretation of FDA’s regulations and

congressional intent behind the entry of generic medications into the market could lead to substantial harm to patients and taxpayers,” they write Collins and McCaskill lead Senate Special Committee on Aging AZN Phase 3 REPROVE trial for Zavicefta (ceftazidime-avibactam) met main goal for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalized patients.Says study met primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21) AZN and AMGN announce top-line results from phase 3 study evaluating ABP 980 compared with Trastuzumab The companies have announced results from a Phase 3 study evaluating efficacy and safety of ABP 980 compared with trastuzumab (Herceptin, ROG.SW) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. The results ruled out inferiority compared to trastuzumab but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR). The primary endpoint had a prespecified equivalence margin of +/- 13% and the observed upper end of the confidence interval was 13.4%. Overall, adverse events were comparable between ABP 980 and trastuzumab. In the neoadjuvant phase of the study, which included chemotherapy, there were more serious adverse events reported in the ABP 980 group, the majority of which were reported by the investigators as unlikely related to investigational product. In the adjuvant phase of the study, which did not include chemotherapy, serious adverse events were comparable between treatment groups. The overall results also showed comparable immunogenicity. BIIB the company might have tried to support its slowing revenue streams or that risky pipeline with M&A or licensing. But Biogen has been much stingier than many of its rivals in those areas. It did say on Thursday's call that it's looking aggressively for deals and to bolster the pipeline. It's past time,,article on BBERG that BIIB needs new strategy. BPMX a specialty pharmaceutical company developing products for the dermatology market, will share findings from the first comparative studies of oral and topical minocycline formulations, which detected no traces of minocycline in the bloodstream when it is applied topically. BioPharmX conducted two directional comparative pharmacokinetics (PK) studies of oral minocycline to topical BPX-01.The comparative studies assessed the impact of a novel topical gel formulation of 1% minocycline and compared it to an extended release oral minocycline to measure skin and plasma concentrations during four-week treatment periods. Results of a 28-day clinical PK study found no detectable minocycline in skin after two weeks of daily oral treatment with a 1-2 mg/kg dose, but did show minocycline concentrations in the plasma. A separate oral gavage versus BPX-01 minipig study also found minocycline in the plasma for minipigs in the oral group, but no minocycline in the plasma for the topical group. At the same time, the minipig study detected minocycline in the skin of the topical group, but found no minocycline in the skin of the oral group. BPX-01 is fully solubilized, non-oily, easy-to-use, and capable of being delivered to sebum-rich areas where P. acnes reside. BIIB CEO George Scangos will step down as head and Biogen's board of directors said it would begin the search for a new chief executive immediately Scangos said he plans to return to the West Coast to "take on one more set of activities" and spend more time with his family. "This is the right time for a new leader to take the reins and lead Biogen through its next stage of development," Scangos said. Scangos leaves Biogen after six years as CEO, during which

the company launched six new products, including its top-selling multiple sclerosis drug Tecifdera. Revenues since 2010 have more than doubled to $10.8 billion last year. Biogen also released quarterly results, upping its financial guidance for 2016 and announcing it would repurchase up to $5 billion of the company's common stock. Although revenue has more than doubled since Scangos took over, Biogen remains almost entirely dependent on its MS portfolio. Last year, sales of the company's five top MS drugs accounted for over 93% of total revenue—with sales of the top-selling Tecfidera representing just under 40%. In May of 2016, BIIB announced it would spin off its hemophilia business into a separate public company, purportedly to free up Biogen to focus on its core neurological portfolio. But that further intensifies the company's reliance on its MS portfolio and increases the pressure on its R&D efforts to expand into other areas. BIIB is currently in Phase 3 development of a treatment for Alzheimer's disease, along with drugs for a certain type of lymphoma and spinal muscular atrophy. In June, however, an investigational drug for relapsing forms of multiple sclerosis missed its primary and secondary endpoints in a Phase 2 trial. , Scangos is leaving on a high note. The company reported a 12% jump in overall revenue in the second quarter, compared to the same period a year prior. Sales of Tecfidera were up as well although its other main MS drug Avonex recorded a 2% decline year over year. "The company now is a very different company from what it was a few years ago. We have a full and excellent management team. We have a pipeline that is quite exciting but needs to grow," Scangos told investors on a call Thursday. BMRN news that RHHBY says that is unlikely to make a big acquisition in the near term.—and RHHBY CEO Severin Schwan declines to comment on speculation co. is interested in buying BioMarin at media event in Basel. RHHBY strategy remains to seek small, medium-sized deals Roche CEO: biotech valuations are too high even after recent market correction BVX Bovie Medical announces sales channel partnership agreement with Hologic for J-Plasma Bovie Medical announces a sales channel partnership agreement with Hologic (HOLX), effective immediately. Hologic will add Bovie’s J-Plasma product line to its portfolio of healthcare solutions in gynecological and gynecological/oncological surgery in three U.S. regions. The initial six-month agreement provides certain members of Hologic’s direct GYN Surgical sales force with access to J-Plasma and includes the option to extend the agreement into a worldwide distribution pact that would involve Hologic’s entire surgical sales force. CI comments on DOJ position regarding proposed transaction with Anthem (ANTM) In response to the DoJ decision to challenge its proposed merger with Anthem, the company has stated the following: “Today, the Department of Justice announced that it will challenge our proposed merger with Anthem. Given the nature of the concerns raised by the DOJ and the overall status of the regulatory process, which under the terms of the merger agreement was led by Anthem, Cigna is currently evaluating its options consistent with its obligations under the agreement. 'In light of the DOJ's decision, we do not believe the transaction will close in 2016 and the earliest it could close is 2017, if at all. CI after more than a year of scrutiny, the U.S. Justice Department filed requests for preliminary injunctions Thursday to block the two health insurance deals led by Aetna and Anthem that would shrink the number of national carriers from five to three if allowed to proceed.For the past year, Aetna has pursued its $37 billion acquisition of Humana to bolster its Medicare Advantage business. Anthem's $53 billion bid for Cigna Corp. would consolidate health insurance administration offered to employers.But federal and state regulators officially sued to block

those deals, citing reduced competition and potential harm to American consumers.The Justice Department will stream their announcement at 11 a.m. EDT. CTIX announces plans to expedite phase 2 trial of Brilacidin-OM for oral mucositis Cellceutix has recently retained several OM consultants and embarked on a rapid expansion of the study with a goal of completing its study enrollment on an expedited basis. The company also has been advised that a competing OM trial, which announced recently that it is being discontinued, has resulted in the availability of a large number of clinical sites, that are being considered to participate in the Cellceutix trial. Likely referring to Sucampo's (SCMP) decision to discontinue development of cobiprostone in OM, announced on JUL 11 2016 DMPI announces presentation at the EANO annual meeting in October DelMar Pharmaceuticals announces that it will present an abstract at the 12th Meeting of the European Association of Neuro-Oncology (EANO) taking place in Mannheim, Germany from 12-Oct – 16, 2016. DelMar will present an abstract entitled: "Dianhydrogalactitol (VAL-083) causes bifunctional alkylation leading to irreparable DNA double-strand breaks, S/G2 phase cell-cycle arrest and tumor cell death in an MGMT independent manner offering a unique treatment paradigm for GBM." The company's EANO presentation will further elucidate how VAL-083 attacks cancer cells utilizing a mechanism of action distinct from other chemotherapies used in the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. Specifically, DelMar will present data supporting the potential of VAL-083 to treat patients whose tumors exhibit features correlated with resistance to the chemotherapies currently used in the treatment of GBM. DNAtrix, a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer, announced the successful intratumoral administration of DNX-2401 with the Alcyone MEMS Cannula (AMC) to patients with recurrent glioblastoma. A substudy is being performed as part of a larger multicenter study to evaluate DNX-2401 as treatment for recurrent glioblastoma, a disease for which there is neither a cure nor adequate treatment. DNX-2401 is a potent oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies in patients with recurrent glioblastoma and gynecologic cancer have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response. The AMC is a dual-lumen MRI-safe neuro-ventricular cannula with the smallest-in-class micro-tip and patented design features that ensure optimal and consistent drug distribution while eliminating backflow. Analysis of intraoperative MRI from the pilot study demonstrates that the AMC delivers DNX-2401 precisely and accurately into the tumor. Neurosurgeons participating in the study have also praised the cannula's ease of use. EOS Imaging announces partnership with Anatoscope for virtual patient models; terms undisclosed EOS imaging announces exclusive partnership with Anatoscope (Montpellier, France) to combine Anatoscope’s virtual patient models with EOS 2D/3D images and datasets into the EOS apps for advanced orthopaedic applications. The first applications will be available in 2017. EOSI EOS Imaging announces partnership with Anatoscope for virtual patient models; terms undisclosed EOS imaging announces exclusive partnership with Anatoscope (Montpellier, France) to combine Anatoscope’s virtual patient models with EOS 2D/3D images and datasets into the EOS apps for advanced orthopaedic applications. The first applications will be available in 2017.

EYES Second sight announces positive five-year data from Argus II retinal prosthesis system The paper entitled "Five year safety and performance results from the Argus II Retinal Prosthesis System Clinical Trial" follows the assessment of 30 subjects in the clinical trial implanted with the Argus II in 10 centers throughout the United States and Europe. All patients were blind (i.e., with bare light perception or worse) from RP or similar disorders. Throughout five years of clinical study, results showed that patients' visual function improved after implantation with the Argus II and these improvements were sustained over five years. Patients reported that using Argus II had a positive impact on their wellbeing, including a renewed connection with loved ones and the world around them. Results also demonstrated that the Argus II had an acceptable safety profile. Eurofins FDA granted emergency use authorization to Eurofins Scientific’s Zika virus test FMS bid for PFE infusion pumps business reportedly stalls on valuation -- Bloomberg An additional headline indicates that Pfizer could potentially keep the pumps business if it does not find a suitable buyer. Galenica to pay $32 per share in cash for RLYP, Relypsa had been rumored for months alenica says deal affirms its commitment to separate Galenica Group into two independent listed companies. Galenica to pay $32 per share in cash for Relypsa .Galenica says deal affirms its commitment to separate Galenica Group into two independent listed companies. Says deal partly financed by equity proceeds to be raised in conjunction with envisaged division of Galenica Group in 2017 Deal gives Vifor Pharma a dedicated U.S. commercial organization and global rights to Veltassa, a potassium binder for treatment of hyperkalaemia Deal bolsters Vifor Pharma presence in U.S. cardio-renal market Boards of both Relypsa and Galenica have approved deal Relypsa board will recommend shareholders accept offer Vifor Pharma intends to retain the Relypsa leadership team Deal expected to complete in 3Q 2016 GILD announced that two Phase 3B switch studies evaluating Odefsey (emtricitabine 200Mg/rilpivirine 25Mg/tenofovir alafenamide 25Mg) for the treatment of HIV-1 infection met their primary objectives. The ongoing studies were designed to explore the efficacy and safety of Odefsey among virologically suppressed adult patients switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera (emtricitabine 200Mg/rilpivirine 25Mg/tenofovir disoproxil fumarate 300Mg) (Study 1216) or Atripla (efavirenz 600Mg/emtricitabine 200Mg/tenofovir disoproxil fumarate 300Mg) (Study 1160). Odefsey combines Gilead’s emtricitabine and tenofovir alafenamide with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Compared to the TDF-based regimens, Odefsey demonstrated statistically significant improvements in bone mineral density (BMD) at the hip and spine (p<0.001) in both studies. Additionally, improvements in total and tubular proteinuria statistically favored Odefsey in both studies (p<0.001). Hikma the U.S. Court of Appeals for the District of Columbia Circuit affirmed an earlier decision of the U.S. District Court for the District of Columbia backing FDA approval of Hikma’s colchicine.Decision means that Hikma may continue marketing colchicine 0.6 mg capsules under the brand name Mitigare, as well as its authorized generic HUM after more than a year of scrutiny, the U.S. Justice Department filed requests for preliminary injunctions Thursday to block the two health insurance deals led by Aetna and Anthem that would shrink the number of national carriers from five to three if allowed to proceed.For the past year, Aetna has pursued its $37 billion acquisition of Humana to bolster its

Medicare Advantage business. Anthem's $53 billion bid for Cigna Corp. would consolidate health insurance administration offered to employers.But federal and state regulators officially sued to block those deals, citing reduced competition and potential harm to American consumers.The Justice Department will stream their announcement at 11 a.m. EDT. HUM and AET respond to DoJ lawsuit Aetna (AET) and Humana Inc. (HUM) announced plans to vigorously defend the companies’ pending merger in response to a U.S. Department of Justice (DOJ) lawsuit seeking to block the transaction. The companies believe that combined company is in the best interest of consumers, particularly seniors seeking affordable, high-quality Medicare Advantage (MA) plans. They add that to date, regulators in 18 of 20 states where change of control applications are required have approved the transaction, with remaining reviews underway. Any perceived competition concerns can be addressed through divestitures. Though the companies do not believe divestitures are necessary, significant and well-established industry players have already submitted bids for MA assets in certain states that regulators may require to be divested Humacyte CIRM approved $10 million to help fund a clinical trial testing a device that could make life easier, and safer for many of those on dialysis.The Phase 3 clinical trial is being run by Humacyte Inc. which is testing a bioengineered vein needed by people undergoing hemodialysis, the most common form of dialysis. The vein – also known as a human acellular vessel or HAV – is implanted in the arm and used to carry the patient’s blood to and from an artificial kidney that removes waste from the blood. Current synthetic versions of this device have many problems, including clotting, infections and rejection. Humacyte has created bioengineered blood vessels that appear to be both safer and more durable than existing HAVs. In addition, over time the patient’s own stem cells start to populate the bioengineered vein, in effect making it part of the patient’s own body.“This approach has the potential to significantly improve our ability to care for people with kidney disease,” says C. Randal Mills, Ph.D., the President and CEO of CIRM. “Being able to reduce infections and clotting problems, and increase the consistency of care hemodialysis patients could get, would meaningfully impact the quality of their lives.”In addition, the CIRM Board approved $3.9 million to develop and test an implantable cell therapy for people with a high-risk form of type 1 diabetes. There are more than 100,000 people in the US with such severe type 1 diabetes that, despite the availability and use of insulin, are at constant risk of hospitalization and even death. The cell therapy, known as PEC-Direct, is being developed by ViaCyte and uses pancreatic progenitor cells which have the ability to turn into all the endocrine cell types found in the pancreas, the organ damaged in diabetes. The pancreatic progenitor cells are delivered in a device that is implanted under the skin where it allows direct vascularization, connecting the cells in the PEC-Direct product to the patient’s blood circulatory system. This vascularization enables the cells to monitor blood sugar levels, detect when they are too high or low, and secrete insulin and other hormones that will restore and maintain blood sugar at healthy levels. HUM company is experiencing better-than-expected performance across several of its businesses resulting in an increase in its FY16 earnings guidance for these businesses. This increase is primarily being driven by better-than-expected performance in the company’s individual Medicare Advantage and Healthcare Services businesses with higher projected FY16 pretax earnings also now projected for certain of the company’s other businesses( Higher projected individual Medicare Advantage pretax results of approximately $185M, or $0.76 per diluted common share), are primarily due to operating initiatives resulting in favorable prior

period medical claims development and lower current-year utilization than was anticipated in pricing. This is allowing the company to begin to return to its targeted margin levels more quickly than previously anticipated The company has also notified relevant DOIs of its intent to discontinue certain on-exchange Individual products across a number of geographies for 2017 and exit substantially all Affordable Care Act (ACA) compliant off-exchange Individual markets. As a result, the company’s 2017 geographic presence for its Individual offerings is expected to cover no more than 156 counties across 11 states, down from 1,351 counties across 19 states in 2016. Humana expects 2017 premiums associated with ACA-compliant offerings in the range of $750M to $1B versus approximately $3.4B projected for FY16. The rate review and approval processes with the related states are ongoing. In March 2016, the Financial Accounting Standards board issued a new pronouncement regarding the accounting for the tax effect of stock-based compensation. As permitted by this accounting standard, the company has chosen to adopt this change effective as of 1-Jan-16, retrospectively impacting the company’s financial results for Q1 of 2016. Consequently, financial guidance for FY16 has been adjusted to reflect a lower projected tax rate, raising the company’s EPS guidance by approximately $0.12 per diluted common share. Aetna Transaction On 21-Jul-16, the U.S. Department of Justice (DOJ) filed a civil antitrust lawsuit seeking to block the transaction. Together with Aetna, the company intends to vigorously defend the transaction in response to the lawsuit. Aetna and Humana previously agreed to extend the time period to obtain regulatory approvals to no later than 31-Dec-16, as permitted under the merger agreement. Judicial review could extend past 31-Dec-16, and therefore, given the uncertainty associated with the timing and outcome of litigation IMSC Implant Sciences announces letter of intent to acquire Zapata Industries; plans to uplist to NASDAQ Implant signs a letter of intent to acquire Zapata Industries SAS of Marseilles, France. Zapata is a profitable and debt-free company with commercial, defense, and homeland security technology applications. The company's agreement with Zapata, subject to shareholder approval, positions the company to emerge debt-free (pending the restructuring which could include a sale of the ETD business or a capital raise) with at least $20M in cash for working capital on the balance sheet in exchange for $15M, 60% equity and 50M warrants exercisable at $1.50 per share. Upon conclusion of the restructuring and meeting NASDAQ listing requirements, the company will pursue an uplisting to the NASDAQ Marketplace. JAJ International is trying to get approval from Brazilian regulators for its Zika virus diagnostic test (San Diego Union-Tribune) LGND strength related to investor sentiment from NVS release of 2Q Promacta sales, which posted the largest dollar increase in the drug’s six year history, LGND CEO John Higgins said in an interview .LGND gets Promacta royalties of 4.7% to 9.4% based on sales Label expansion for Promacta continues, with “largest indications yet to come” and patent protection for a decade MASI notes study of PVI as predictor of fluid responsiveness in patients undergoing liver transplantation MASI announced that a new study of patients undergoing liver transplantation evaluated the relationship of PVI to right ventricular end-diastolic volume and concluded that PVI provided a “reliable estimate of [cardiac] preload status and may be a useful predictor of fluid responsiveness.” PVI measures the dynamic changes in perfusion index that occur during one or more complete respiratory cycles, using the Masimo pulse oximetry plethsymographic waveform. The prospective study published in Transplantation Proceedings and conducted at Chang Gung Memorial Hospital in Taiwan.

MATN announces enrollment of first patient in Phase II portion of PAZOFOS study The company announced that the first patient has been enrolled into the Phase 2 portion of the PAZOFOS Study. The PAZOFOS Study is a Phase 1B/2 clinical trial in patients with recurrent ovarian cancer that will assess the efficacy and safety of the combination of Mateon’s investigational drug CA4P plus Novartis’ approved tyrosine kinase inhibitor pazopanib (Votrient) compared to pazopanib alone. The primary outcome measure of the Phase 2 portion of the study is progression free survival measured by RECIST; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers. The study is designed to enroll 128 patients at ten sites in the United Kingdom. MDSO Medidata Solutions downgraded to market perform from outperform at Wells Fargo Sees potential for material deceleration of organic growth in 2018 Valuation Range raised to $52-55 however, from $47-5 MRK provides regulatory update on BLA for Bezlotoxumab and ; FDA requests new data the pdufa date is extended to Oct 23 2016. Merck said that the FDA has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending BLA for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The additional data and analyses constitute a major amendment to the BLA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months. MYL and Biocon announce MAA submission for biosimilar pegfilgrastim accepted for review by EMA Mylan and Biocon (532523.IN) announced that the European Medicines Agency (EMA) has accepted for review, Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Pegfilgrastim (Neulasta, AMGN) Newron started pivotal clinical study to evaluate the efficacy, safety and tolerability of sarizotan in patients with Rett syndrome suffering from respiratory symptoms. Study to enroll 129 patients in the U.S., Italy and India Company expects to have top-line results available for release in 2017 NUAN is diving deeper into the customer engagement industry with its latest buy. By spending $215 million to buy California's TouchCommerce, a maker of software that powers live chat, self-service guides and data-driven personalization on various corporate websites. TouchCommerce, which had been a Nuance technology partner, counts Comcast, Citizens Banks and AT&T as some clients.Nuance said it will pay $110 million in cash and $85 million in a combination of cash and Nuance common stock determined by Nuance, and the remaining $20 million will be paid.The deal has been approved by both companies boards of directors and is expected to close by the end of this year, according to Nuance. ONCE Spark Therapeutics and PFE Pfizer receive FDA breakthrough therapy designation for SPK-9001 Spark Therapeutics (ONCE) and Pfizer Inc. (PFE) announced that the FDA has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies’ SPK-FIX program, in development for the treatment of hemophilia B Breakthrough therapy designation is intended to expedite the development and FDA review of drugs to treat a serious or life-threatening disease or condition The designation requires preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint ONO Japan Health Ministry considers setting rules on new drug usage during this fiscal year beginning with Ono Pharma’s Opdivo, Nikkei reports, without attribution. Govt plans to require

hospitals to have in-patient facility with 24-hour diagnosis capacity and resident doctors with chemotherapy expertise. Patients may be limited to those who can see certain impact from the treatment Ministry to also specify guidelines for Astellas Pharma’s Repatha as well QCOM the biggest maker of semiconductors that run smartphones, reported earnings and gave forecasts that beat analysts’ estimates as it gets paid more licensing fees in China and gains market share there. Intel posted growth in its data center business that fell well PBYI has submitted a NDA to the FDA for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy. The submission is supported by the results of the ExteNET Phase III study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). Pdufa could be in one year Jul 21 2017 PBYI updates Phase III clinical trial of PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer The primary endpoint of the trial was invasive disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive DFS rate for the neratinib arm was 93.9% and the 2-year invasive DFS rate for the placebo arm was 91.6%. PFE ONCE Spark Therapeutics and PFE Pfizer receive FDA breakthrough therapy designation for SPK-9001 Spark Therapeutics (ONCE) and Pfizer Inc. (PFE) announced that the FDA has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies’ SPK-FIX program, in development for the treatment of hemophilia B Breakthrough therapy designation is intended to expedite the development and FDA review of drugs to treat a serious or life-threatening disease or condition The designation requires preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint PFE FMS bid for Pfizer's infusion pumps business reportedly stalls on valuation -- Bloomberg An additional headline indicates that Pfizer could potentially keep the pumps business if it does not find a suitable buyer. PIP news that SIGA Technologies filed the Joint Motion of Reorganized Debtor and PharmAthene, Inc. to Amend Debtor’s Third Amended Chapter 11 Plan to Extend PharmAthene Allowed Claim Treatment Date . The Joint Motion was filed with the United State Bankruptcy Court for the Southern District of New York . . The Joint Motion seeks approval of amendments to the Plan that would extend the deadline for SIGA to satisfy the previously disclosed judgment owed to PharmAthene, Inc. from Oct 19 2016 to Nov 30 20166, conditioned on SIGA’s payment to PharmAthene of $100M on or prior to Oct 19 2016 that will be applied against PharmAthene’s judgment. A hearing to consider the Joint Motion is scheduled to be held before the Bankruptcy Court on Aug 15 2016 No assurance can be given that the Joint Motion will be approved by the Bankruptcy Court. ProMIS Neurosciences company focused on the discovery and development of precision treatments for neurodegenerative diseases, today announced that it has appointed Johanne Kaplan, PhD, to the position of Chief Development Officer. In this new role, reporting to both the Executive Chairman and CEO, Dr. Kaplan will focus on supporting the design and execution of ProMIS' development programs and partnering efforts."We are pleased to welcome Dr. Kaplan as her extensive skill set and experience will add significant value to the ProMIS team and to

this important new role," said ProMIS Executive Chairman, Eugene Williams. "Dr. Kaplan's track record of successfully managing development-stage programs will benefit the Company as we approach the selection of the final lead candidates for development in our Alzheimer's disease portfolio. Furthermore, her experience as a senior executive in pharmaceutical industry in-licensing and product acquisition will be integral as we pursue partnering opportunities." Johanne Kaplan joins ProMIS following 24 years at Genzyme (a Sanofi company), where she held positions of increasing responsibility, culminating in her decade-long tenure as Vice President of Research, most recently directing the multiple sclerosis and neuroimmunology research effort. RDHL receives additional U.S. patent covering RHB-105 RDHL announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering RHB-105, a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection. The patent application, entitled “Pharmaceutical Compositions For The Treatment Of Helicobacter Pylori” expands RedHill’s patent portfolio covering RHB-105 and is expected to be valid until 2034, once granted. Relievant Medsystems a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, i received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least six months of conservative care caused by changes associated with degeneration of spinal vertebral bodies and the associated intervertebral discs.The INTRACEPT System uses radio frequency (RF) energy, delivered through specially designed instruments via a minimally invasive approach to access and ablate the basivertebral nerve (BVN.) The BVN is a sensory nerve within each vertebral body, which transmits the sharp, aching or throbbing pain experienced with degenerated vertebral bodies. Spine specialists can use the INTRACEPT System to treat one or more levels between L3 and S1 in the lower spine. Resverlogix dosing has commenced in a Phase 1 PK study with lead drug candidate apabetalone (RVX-208) in patients with severe renal impairment. The primary objective of the Phase 1 study, based in New Zealand, is to determine if apabetalone treated patients with severe renal impairment have the same favorable PK traits as has been witnessed in previous apabetalone trials. Results are expected in H2 of 2016, and if successful, will allow for more advanced renal impairment and dialysis trials to proceed. The study will also explore acute changes in biomarkers relevant to Bromodomain and Extra-Terminal (BET) inhibition in subjects with severe renal impairment. RHHBY confirms 2016 outlook: Expects sales to grow low-to-mid-single digit at constant FX Core EPS targeted to grow ahead of sales at constant FX , RHHBY expects to further increase dividend in CHF RHHBY says that is unlikely to make a big acquisition in the near term.-- Roche CEO Severin Schwan declines to comment on speculation co. is interested in buying BioMarin at media event in Basel.Roche strategy remains to seek small, medium-sized deals Roche CEO: biotech valuations are too high even after recent market correction RLYP finally a deal. Galenica to pay $32 per share in cash for Relypsa .Galenica says deal affirms its commitment to separate Galenica Group into two independent listed companies. Says deal partly financed by equity proceeds to be raised in conjunction with envisaged division

of Galenica Group in 2017 Deal gives Vifor Pharma a dedicated U.S. commercial organization and global rights to Veltassa, a potassium binder for treatment of hyperkalaemia Deal bolsters Vifor Pharma presence in U.S. cardio-renal market Boards of both Relypsa and Galenica have approved deal Relypsa board will recommend shareholders accept offer Vifor Pharma intends to retain the Relypsa leadership team Deal expected to complete in 3Q 2016 SHPG is launching pediatric indication for HyQvia across Europe This follows the recent marketing authorisation granted by the European Commission to Baxalta, now part of Shire, in Jun. Shire is commercially introducing the new indication across the member states of Europe, starting this month with Germany, The Netherlands, Ireland, Greece, Slovakia, Denmark, Sweden and Norway. Shire (Baxter at the time) initially obtained marketing authorization for HyQvia in Europe in May-13. The product is also licensed in the US, in Puerto Rico, and Australia, and currently under review in Brazil, Columbia, Mexico, and Argentina. SIGA Technologies filed the Joint Motion of Reorganized Debtor and PharmAthene, Inc. to Amend Debtor’s Third Amended Chapter 11 Plan to Extend PharmAthene Allowed Claim Treatment Date . The Joint Motion was filed with the United State Bankruptcy Court for the Southern District of New York . The Joint Motion seeks approval of amendments to the Plan that would extend the deadline for SIGA to satisfy the previously disclosed judgment owed to PharmAthene, Inc. from Oct 19 2016 to Nov 30 20166, conditioned on SIGA’s payment to PharmAthene of $100M on or prior to Oct 19 2016 that will be applied against PharmAthene’s judgment. A hearing to consider the Joint Motion is scheduled to be held before the Bankruptcy Court on Aug 15 2016 No assurance can be given that the Joint Motion will be approved by the Bankruptcy Court. SPNC Appeals Court orders dismissal of state-law claims in Spectranetics subsidiary AngioScore's litigation with TriReme et al over angioplasty balloon catheters Background: On 29-Jun-12, AngioScore sued TriReme Medical, Quattro Vascular, QT Vascular and Eitan Konstantino (the Defendants), alleging the defendants' new angioplasty balloon catheter, Chocolate, infringed on AngioScore's patent 7,691,119 AngioScore later added state-law claims for breach of fiduciary duty, aiding and abetting, and unfair competition. After separate trials on the patent and state-law claims, the district court entered final judgment for the Defendants on the patent claim, for AngioScore on the state-law claims, and denied TriReme et al's request for attorneys’ fees AngioScore was awarded $20.034M for the state-law claim of a breach of fiduciary duty on the part of Konstantino (see linked comment for reference) Defendants appealed the district court’s exercise of jurisdiction over the state-law claims and the denial of attorney's’ fees Ruling: "Because we find that the district court improperly exercised supplemental jurisdiction over the state-law claims but did not err in denying attorneys’ fees, we reverse-in-part, affirm-in-part, vacate-in-part, and remand with instructions to dismiss the state-law claims for lack of jurisdiction Theranos in an effort to correct its course, beleaguered blood-testing company Theranos has hired two executives to manage compliance and regulatory matters.Theranos tapped Dave Wurtz, senior director of regulatory, quality and compliance at Thermo Fisher Scientific (TMO), as its new vice president of regulatory and quality affairs.Theranos named Daniel Guggenheim, an attorney specializing in regulatory law formerly with McKesson Corp. (MCK), as its new chief compliance officer.Wurtz will be leading the strategy and implementation of Theranos' pre- and post-market regulatory activities, including obtaining Food and Drug Administration clearances and approvals. He will also be responsible for the marketing of new products and managing the

regulatory affairs, medical device quality systems and clinical affairs teams, Theranos said. Wurtz has a big challenge ahead of him as Theranos has faced intense scrutiny over its testing procedures and products—scrutiny that resulted in the company’s founder and chief executive, Elizabeth Holmes, being banned earlier this month from owning or operating a blood testing laboratory for two years. TNDM and TypeZero Technologies announce license agreement for development and commercialization of closed-loop artificial pancreas system Tandem Diabetes Care and TypeZero Technologies, a digital health and personalized medicine company, announced that they have entered into a License agreement allowing Tandem to integrate TypeZero’s artificial pancreas technology into a next-generation t:slim Insulin Pump. TypeZero’s AP technology includes a series of treat-to-target algorithms developed by TypeZero from initial research conducted at the University of Virginia. To date, this technology has been used in more than 28 clinical studies including more than 475 participants, with data referenced in a number of journal articles. The terms of the License agreement between Tandem and TypeZero include a worldwide, non-exclusive license for the use of TypeZero’s AP technology in future Tandem products. The agreement also provides Tandem access to TypeZero’s future AP innovations over the next five years. The two companies plan to work together closely to expedite the clinical research associated with the development of Tandem’s closed-loop AP system. The terms of the License agreement also anticipate that a research version of Tandem’s t:slim Insulin Pump will be used alongside TypeZero’s AP technology in the International Diabetes Closed Loop Trial (IDCL) scheduled to commence later this year, which is funded by the National Institute of Health (NIH), a part of the U.S. Department of Health & Human Services. Financial details of the agreement have not been disclosed. Transgene to Continue Phase 1/1B Study with TG1050 in Chronic Hepatitis B Patients on the Recommendation of the Trial’s Safety Review Committee Transgene announced that the Safety Review Committee of the Phase 1/1B trial with TG1050, Transgene’s immunotherapy product candidate for the treatment of chronic hepatitis B virus (HBV) infection, has recommended that the study should continue. The primary objectives of the Phase 1/1B study are to evaluate the safety and tolerability of TG1050 administered in single and multiple doses and to determine the dose and schedule of TG1050 administration for further development. Secondary objectives include evaluating the antiviral activity of and immune responses to TG1050 Tissue Regenix Group will be featured on episode of Innovations airing via the Discovery Channel on Jul 21 2016 The show will travel to Curitiba, Brazil to see how tissue Regenix unique dCELL technology is transforming the lives of heart valve patients, with over 1,600 operations now undertaken TypeZero Technologies and TNDM Tandem Diabetes Care and announce license agreement for development and commercialization of closed-loop artificial pancreas system Tandem Diabetes Care and TypeZero Technologies, a digital health and personalized medicine company, announced that they have entered into a License agreement allowing Tandem to integrate TypeZero’s artificial pancreas technology into a next-generation t:slim Insulin Pump. TypeZero’s AP technology includes a series of treat-to-target algorithms developed by TypeZero from initial research conducted at the University of Virginia. To date, this technology has been used in more than 28 clinical studies including more than 475 participants, with data referenced in a number of journal articles. The terms of the License agreement between Tandem and TypeZero include a worldwide, non-exclusive license for the use of TypeZero’s AP

technology in future Tandem products. The agreement also provides Tandem access to TypeZero’s future AP innovations over the next five years. The two companies plan to work together closely to expedite the clinical research associated with the development of Tandem’s closed-loop AP system. The terms of the License agreement also anticipate that a research version of Tandem’s t:slim Insulin Pump will be used alongside TypeZero’s AP technology in the International Diabetes Closed Loop Trial (IDCL) scheduled to commence later this year, which is funded by the National Institute of Health (NIH), a part of the U.S. Department of Health & Human Services. VAREX Imaging Corp will be the name of the VAR spin off of imaging components business to Varian Medical Systems announced that Varex Imaging Corporation will be the name for its Imaging Components business upon the completion of the planned spin-off of that business as a new, stand-alone public company via a tax-free distribution to Varian stockholders in a transaction anticipated to be completed by the end of calendar year 2016. VAR spin off of imaging components business to be named Varex Imaging Corporation Varian Medical Systems announced that Varex Imaging Corporation will be the name for its Imaging Components business upon the completion of the planned spin-off of that business as a new, stand-alone public company via a tax-free distribution to Varian stockholders in a transaction anticipated to be completed by the end of calendar year 2016.

BBERG on the med device industry The medical device industry has voiced the most fervent opposition within the healthcare sector to an Obamacare tax. The law imposes a 2.3% excise tax on the sale of most devices. The industry's intense lobbying efforts produced some results, as Congress enacted a two-year moratorium on the tax for 2016 and 2017. The House passed legislation in 2015 (H.R. 160) repealing the tax entirely, though it won't be enacted this year. Pressure to repeal or further delay it will likely resume in 2017. Companies Impacted: Medical-device manufacturers such as industry leaders Medtronic, General Electric, Johnson & Johnson, Boston Scientific, Siemens, Thermo Fisher Scientific and St. Jude Medical could see profit margins boosted if the Obamacare excise tax on medical devices were repealed.

Slingshot Insights the excellent portal created by Joe Mccann on MCRB and NBIX Slingshot Insights Will Sponsor An Expert Interview That You Can Join For Free. Option 1: Discussing the upcoming Phase 2 results Seres intends to release for their Clostridium Difficile Infection drug SER-109. Could this become the new standard of care? Option 2: Reviewing Neurocrine’s impending Phase 2 results for treating Tourette Syndrome with Valbenazine. What can we expect data-wise and what could this mean for the market? This week covers upcoming Phase 2 results from Seres Therapeutics (MCRB) and Neurocrine Biosciences . Seres anticipates releasing Phase 2 results for its CDI drug SER-109 mid-2016. Having already passed the midpoint of the year, these results should be coming within the next few weeks. Investors should take note, current CDI drugs are often ineffective and the market grows larger each year. Option 1 takes a hard look at SER-109 for CDI and raises some questions about MCRB where a subject matter expert's views could prove insightful. NBIX Neurocrine foresees its Phase 2 data for two studies examining the efficacy of treating Tourette Syndrome with Valbenazine arriving by the end of 2016. Why might pharma investors care? TS is a common, not entirely understood disease with a large underserved market. Option

2 expands on NBIX's potential TS drug and poses expert questions regarding the upcoming data.

Bioworld lead article on TB TB commentary from the 2016 Intl Aids Conf .Tuberculosis is airborne, kills millions of people, and drug resistance is spreading, Unlike HIV, there is a vaccine available for TB, and the disease can be cured, at least for now. But the BCG vaccine for TB is 95 years old. The vaccine is effective. It prevents severe TB with 80 percent efficacy, pulmonary TB with 50 percent efficacy, and infection with an estimated 20 percent efficacy. But the vaccine is not effective in adults, and children do not spread TB. There are currently three TB vaccines in advanced trials – one in phase III, and two in phase II. president of South Africa’s medical research council, that’s not enough. .And in the opinion of Glenda Gray, “When you look at the TB vaccine pipeline, you want to cry,” Earlier in the pipeline, though, there is a “massive shift” going on, the Bill and Melinda Gates Foundation’s deputy director for tuberculosis Willem Hanekom said. Hanekom described what he sees as seven novel ideas being tested in the TB vaccine field. Some of those ideas are conceptual, such as targeting adults and adolescents, aiming to prevent TB infection as well as TB disease, targeting unconventional and even unnatural forms of immunity, and targeting conventional T cell responses more effectively. Others are practical, such as vaccinating via an aerosol and repeatedly moving back and forth between preclinical and clinical models. Finally, Hanekom called out one specific approach, a cytomegalovirus-based vaccine technology first discovered by Oregon Health Sciences University’s Louis Picker and being used for the development of TB, HIV and other vaccines by startup Tomegavax Inc., as being particularly promising. Hanekom said that if the vaccines that are currently in clinical trials do not end up being successful, those innovations will be critical to get a handle on TB. “Can we control TB without an effective vaccine? The answer is unequivocally no,” he said. TBs status as a relative backwater to HIV can be seen in the drug as well as the vaccine pipeline. While there have been 37 drug approvals for HIV drugs since the approval of AZT in 1987, the FDA has approved one new drug for TB in the past 40 years – Sirturo (bedaquiline, Janssen Therapeutics). Another drug, Deltyba (delamanid, Otsuka Pharmaceutical Co. Ltd.) has been approved by the European Medicines Agency. And the TB medicines were approved on the basis of far less clinical evidence. By the time HIV integrase inhibitor Vivicay (dolutegravir, Glaxosmithkline plc.) was approved, it had been tested in a total of 61 clinical trials. The number for Deltyba? Six. “We just have so little data on the drugs and how to use them,” Michael Frick of the Treatment Action Group lamented in a talk on access to scientific advances as a human right. At the conference, the general sense was that developing better TB drugs will necessitate gaining a better understanding of the basic biology of TB infection

YCBB New data shows Huawei’s smartphone sales growth slowed sharply in the second quarter, and the company will be lucky to log 20 percent annual growth due to saturation in its home China market.Huawei smartphone growth slows sharply in Q2. The first of many reports for second-quarter smartphone sales has just come out, revealing one of the first declines in more than a year for the surging Huawei. At the same time, the new data from TrendForce show that surging Chinese brands Oppo and Vivo are also seeing rapid slowdowns in their recent breakneck growth. The bigger picture is that the global smartphone market is slowing sharply or even

contracting after years of rapid growth, with global leaders AAPL and and Samsung also suffering big drops this year.Some might argue that the 26 percent shipment growth posted by Huawei in this year’s second quarter looks relatively solid, and indeed it far outpaces an overall rise of 3.2 percent in global smartphone sales for the period, according to TrendForce. But the figure is well below Huawei’s previous growth rates that were typically much higher, including 58 percent growth in this year’s first quarter, according to IDC.The bigger picture seems to be that China’s smartphone market, the world’s largest, has become highly saturated and none of the brands will see big gains there for the foreseeable future. That’s important because China was largely responsible for the meteoric growth of most of these domestic brands over the last 2 years, and was also a major factor behind Apple’s boom. All that said, the big factor for all of these companies going forward will be their ability to grow outside China, especially by cultivating emerging markets like the BRICS where penetration rates are typically low. In that regard, Huawei and the struggling Lenovo (HKEx: 992) and ZTE (HKEx: 763; Shenzhen: 000036) might have an advantage, since they already have extensive overseas networks. Others like Xiaomi are learning that building such networks takes time and isn’t easy, and for those reasons could face more difficulty. AmTRAN as next target for LeEcoMedia?, rumors have been buzzing these last few days about rumors of a potential acquisition by online video superstar LeEco (of the struggling low-cost TV brand Vizio, owned by Taiwan’s AmTRAN Technology, article on YCBB

ZITA Today from STAT The CDC may give Florida an additional $5.6 million in funding to help determine whether a case reported earlier this week is the first instance of Zika infection by a mosquito in the continental US (White House) JAJ International is trying to get approval from Brazilian regulators for its Zika virus diagnostic test (San Diego Union-Tribune) Eurofins FDA granted emergency use authorization to Eurofins Scientific’s Zika virus test

Bioworld headlines PGNX Oral Relistor approval article and potential competitor to AZN: VRX marketing effort to could uptick over AZN Movantik? Progenics Pharmaceuticals Inc. stands to collect $50 million, , thanks to approval by the FDA of oral Relistor (methylnaltrexone bromide), partnered with Valeant Pharmaceuticals International Inc. for opioid-induced constipation (OIC) in adults with chronic noncancer pain. Relistor has been available since 2008 in subcutaneous form,and the oral version – 450-mg tablets once daily – will compete with AZN Movantik (naloxegol) tablets. Relistor, like Movantik, targets the mu opioid receptor, “which is where this problem has been created,” he said. “Why do we think Relistor may be the stronger competitor? An important thing in our mind is the speed of onset of action with Relistor. If you’re a person suffering from constipation, this is high on your list.” No specific treatments for OIC that address the underlying cause have been approved, “so people have been using over the- counter laxatives for lack of anything better,” he said. “The laxatives have just not been that effective.” For Movantik, Astrazeneca has a co-commercialization agreement with Daiichi Sankyo Co. Ltd., of Tokyo, in the U.S., under which Daiichi provided $200 million upfront plus sales-related payments of up to $625 million. The firms have been doing much to promote Movantik, “including a disease awareness ad that was on the last Super Bowl,” Baker said. “We expect that Valeant will make

similar efforts, in addition to the efforts they have been making in selling the subcutaneous” Relistor. The Super Bowl ad drew some fire from politicos and in social media, where some claimed it encouraged the use of opioids.Brean Capital analyst Jonathan Aschoff said his firm “believes that oral Relistor will see significant uptake because it can be used on a pro re nata [as needed] schedule, due to its more rapid, predictable onset of action. Predictability is important for constipation drugs.” In a research report, he noted that Progenics would get one-time milestones of $10 million, $15 million, $20 million, $30 million, $50 million, and $75 million that will be triggered by minimum calendar year Relistor sales of $100 million, $150 million, $200 million, $300 million, $750 million, and $1 billion, respectively. “We believe that all but the last milestone will all be achieved by 2020, and have modeled the first two in 2017, the next two in 2018, and the fifth in 2020,” Aschoff said ZFGN Zafgen Inc. scrapped plans to develop its lead candidate, beloranib, after deciding the road forward would be too long and costly, based on FDA feedback, following two patient deaths in its phase III bestPWS trial in Prader-Willi syndrome (PWS). As for beloranib, the company is weighing its options. In 2009, Zafgen executed an exclusive global license for the compound with Chong Kun Dang (CKD) Pharmaceutical Corp. and maintains global ownership of the asset outside South Korea. Composition-of-matter patents on beloranib are set to expire in 2019, but an issued U.S. patent relating to beloranib polymorph compositions of matter does not expire until 2031, and an issued U.S. patent to methods for treating obesity expires in 2029. The company is in discussions with CKD about the fate of beloranib but Hughes dismissed as “premature” any notion of monetizing the asset. “If we are not pursuing beloranib, there may be an obligation for us to return the asset,” he said. “We need to see the next steps on that and also see if there’s any incoming interest.” To conserve resources, the Boston-based company also is trimming its work force by approximately 34 percent, to 31 employees, by December. Patrick Loustau, the company’s president, and Alicia Secor, chief commercial officer, were among those jettisoned, although Secor quickly landed at Juniper Pharmaceuticals Inc., where she was named president Precision Ocular Ltd overview: the company is taking a dual approach to changing intravitreal injections by combining a device that can target delivery to specific parts of the eye with novel formulations of new and existing drugs. The lead product will be for treating diabetic macular edema. The aim is minimize the amount of drug administered while lengthening the time for which it remains effective. “To do this, there have got to be very accurate injections, accessing very small spaces for drug delivery. Precision Ocular closed a £15.5 million (US$20.4 million) series A funding that will enable it to take the first of new generation of low-dose, slow-release retinal drugs from preclinical research and into the clinic.

July 20, 2016

My Informal takeover notes with attributions *health in green, tech in purple, energy/basic in blue, retail in maroon, financials in orange, miscellaneous in black

Jul 20 2016 JNJ in terms of mergers and acquisitions, Caruso said, “Our strategy in pharma is licensing and collaborations and not major acquisitions. That doesn’t mean we’re not going to do one.”, article on Biospace

Jul 19 2016 FOMX while the company may or may not be attractive as a takeover target in the near-term, successful FMX101 phase 3 trial results could provide further validation

for its foam-based platform and could make some large cap pharma companies more interested. PFE acquisition of ANAC is a good enough reason to think that the dermatology space is very attractive, especially if one can get an advantage over competitors through differentiation via improved efficacy and safety in a quite large addressable market, article on FOMX in Seeking Alpha

Jul 19 2016 PFE in regards to FOMX, while the FOMX may or may not be attractive as a takeover target in the near-term, successful FMX101 phase 3 trial results could provide further validation for its foam-based platform and could make some large cap pharma companies more interested. PFE acquisition of ANAC is a good enough reason to think that the dermatology space is very attractive, especially if one can get an advantage over competitors through differentiation via improved efficacy and safety in a quite large addressable market, article in Seeking Alpha

Jul 19 2016 AZN has rebuffed takeover offers in the past, but will prior suitors come back to the table? Are there others lurking on the sidelines? Let's talk, article in Seeking Alpha

Jul 18 2016 PACB on as takeover bait for RHHBY on Seeking Alpha from Jul 17 2016

Jul 28 2016 RHHBY as potential suitor for PACB on Seeking Alpha from Jul 17 2016

New health & related events to add Center for Strategic and International Studies (CSIS) Global Health Policy Center and Kaiser Family Foundation will host a briefing to assess the major outcomes of the 2016 International AIDS Conference (AIDS 2016), held from July 18-22 in Durban, South Africa. The discussion will touch on the latest scientific advancements, the current funding climate for HIV response, and other developments and contributions to the field emerging from the conference Panelists will include Chris Beyrer, President of the International AIDS Society; Ambassador Deborah L. Birx, the U.S. Global AIDS Coordinator; and Jen Kates, Kaiser Family Foundation Vice President and Director of Global Health and HIV Policy. J. Stephen Morrison, Senior Vice President and Director, Global Health Policy Center at CSIS, will moderate the panel discussion Aug 3 2016 VC Angel event in NYC will discuss terms, valuations, the NYC investing landscape, what's getting the attention of Angels & VCs, how Crowdfunding fits in and more Moderator: David Sorin, McCarter & English Moderator: Kevin Pianko, WeiserMazars Welcome Address: Alan Cutter, AC Lion Jay Levy, Zelkova Ventures Laurel Touby, Flatiron Investors David Goldberg, Corigin Ventures Robert Hayden, NY Life Ventures Caryn Effron, Angel Investor Katherine O'Neill, Jumpstart NJ Angels Peter Weiss, ARC Angel Fund Ravi Patel, Audience Ventures Beau Gordon, Stagefront Partners 2pm - 6pm Aug 4, 2016 AGBT Precision Health conference unites the world’s leading clinical translation professionals for three days of keynote talks and industry insights.builds upon the successful model defined by the annual AGBT’s meeting, recognized worldwide as the leading genomic technology research conference Diana Bianchi, Tufts Medical Center Stephen Kingsmore, Rady Children’s Hospital Heidi Rehm, Harvard Medical School Richard Daly, DNAnexus William Gahl, National Human Genome Research Institute, National Institutes of Health Mia Levy, Vanderbilt-Ingram Cancer Center Amy McGuire, Baylor College of Medicine Nickolas Papadopoulos, Johns Hopkins School of Medicine

Kenna Mills Shaw, MD Anderson Cancer Center Alan Shuldiner, Regeneron Genetics Center Howard Jacob, HudsonAlpha Imran Haque, Counsyl Pre-Conference Topics include: NGS 101 NGS data analysis Challenges of NGS data interpretations NGS applications lectures and roundtables- Scottsdale, Arizona, Sep 22-24 2016 WSJ Global Food Forum- NYC MON CPB PNRA INGR, speakers include Michael J Frank of MON, Denise Morrison of CPB, Ronald Schaich of PNRA and others- NYC Oct 6 2016 Immuno-Oncology 36- NY NY Feb 1-3 2017 Patients as Partners Europe- London Feb 6-7 2017 Dpharm Europe- London Feb 8-9 2017 Evidence Europe 2017- London Feb 22-23 2017 Pharma Pricing and Market Access Europe 2017- London Feb 22-23 2017 Patients as Partners – Philadelphia Mar 2-3 2017 R&D Leadership Summit – Manalapan Florida Mar 9-10 2017 Clinical Outsourcing & Partnering World Europe - London Mar 8-9 2017 Clinical Trial Collaborations – Boston Apr 3-4 2017 World Drug Safety Americas 2017 – Chicago Apr 19-20 2017 Digital Path 2017- London May 9-10 2017 Chief Medical Officer East May 10-11 2017 Rational Combinations 360 – NY NY Jun 28-29 2017

NEJM PERSPECTIVE Obamacare’s Skyrocketing Premiums? Why the Sky Isn’t Falling We won’t know until later this year what the final 2017 premium rates will look like for Americans obtaining insurance from the ACA’s exchanges. But regardless of what ends up happening this year, it seems likely that next spring will bring renewed claims that the sky is falling — when experience should make clear that it isn’t. Beyond the Ebola Battle — Winning the War against Future Epidemics History of Medicine: Donabedian’s Lasting Framework for Health Care Quality

NEJM ORIGINAL ARTICLES Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years The extension of treatment with an adjuvant aromatase inhibitor to 10 years resulted in significantly higher rates of disease-free survival and a lower incidence of contralateral breast cancer than those with placebo, but the rate of overall survival was not higher with the aromatase inhibitor than with placebo Immunogenicity of a Meningococcal B Vaccine during a University Outbreak conclusions Eight weeks after the second dose of the 4CMenB vaccine was administered, there was no evidence of an hSBA response against the outbreak strain in 33.9% of vaccines, although no cases of meningococcal disease caused by N. meningitidis B were reported among vaccinated students. Brief Report: Proopiomelanocortin Deficiency Treated with a Melanocortin-4 Receptor Agonist patients with rare defects in the gene encoding proopiomelanocortin (POMC) have extreme early-onset obesity, hyperphagia, hypopigmentation, and hypocortisolism, resulting from the lack of the proopiomelanocortin-derived peptides melanocyte-stimulating hormone and corticotropin. In such patients, adrenal insufficiency must be treated with hydrocortisone early in life. No effective pharmacologic treatments have been available for the hyperphagia and obesity that characterize the condition. In this investigator-initiated, open-label study, two patients with

proopiomelanocortin deficiency were treated with setmelanotide, a new melanocortin-4 receptor agonist. The patients had a sustainable reduction in hunger and substantial weight loss (51.0 kg a Antiretroviral Therapy for the Prevention of HIV-1 The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Disease

NEJM REVIEW ARTICLE Medical Considerations before International Travel

NEJM EDITORIALS Changing Adjuvant Breast-Cancer Therapy with a Signal for Prevention The absence of a report on overall survival benefit in the MA.17R trial at this time should not be surprising. The participants, who in most cases underwent randomization approximately 10 years after the time of diagnosis, have passed the peak risk of recurrence and a considerable proportion of their remaining risk as well. In any event, avoiding a new diagnosis of invasive breast cancer is a benefit in itself. However, the absence of a survival effect will be considered as oncologists and patients with breast cancer weigh the risks and benefits of the use of long-term adjuvant endocrine therapy. A Challenge in Vaccine Development — Neisseria meningitidis Serogroup B 4CMenB will not be the last vaccine for which a traditional, pivotal, double-blind, randomized, controlled trial with hard clinical end points is difficult, if not impossible, to generate. At one end of this spectrum are vaccines such as 4CMenB, for which the severity of the illness (despite treatment) and the existence of presumed correlates could make a compelling case for the use of the statutory accelerated pathway for product approval. At the other end, the alternate, accelerated approval pathway may be required to accommodate vaccines targeting pandemic threats or limited outbreaks (e.g., Ebola virus disease, Zika virus disease, or the Middle East respiratory syndrome). The regulatory approval and clinical use of vaccines for pathogens that cause outbreaks will remain challenging. Hormone-Replacement Therapy for Melanocyte-Stimulating Hormone Deficiency How might the results of setmelanotide treatment in patients with proopiomelanocortin deficiency apply to common forms of obesity? This is the elephant in the room. The example of leptin may be informative. Leptin replacement in patients with a deficiency due to leptin mutations or lipodystrophy produces dramatic clinical benefits. However, leptin treatment of patients with common obesity, who have high leptin levels, was unsuccessful. On the other hand, MC4R is an unusual receptor in that heterozygous loss of function causes a phenotype, whereas for many receptors, loss of one allele produces no obvious effect. This may make MC4R agonism a “sweet spot” for drug therapy, if a modest increase in signaling provides more clinical benefit than risk. It will take years and many more patients to answer this deceptively straightforward question.

Street Insider on Kellogg's K Kellogg (shares fell sharply from speculative highs Wednesday after CNBC's David Faber said recent takeover rumors involving a Warren Buffett Berkshire Hathaway takeover of the company have no merit.Faber said the rumors, in addition to sprouting up on the recent WhiteWave/Danone deal, can be traced back to a hedge fund that tracks airplane tail numbers. The hedge fund presented data on airplane activity between Omaha (Warren Buffet HQ), Battle

Creek (Kellogg HQ), Chicago (Kraft Heinz/3G), and Southern California (Charlie Munger and Director).While interesting, Faber said, after talking to people that would "absolutely" know, they indicate "there is nothing going on here."

The Street on AAPL and benefits from Softbank deal AAPL Apple’s investment in China's Didi Chuxing, a competitor of Uber, creates a link with SoftBank in this market and in Apple's unofficial self-driving car endeavor. Apple's investment also has the potential for increased sales of iPhones in China and India. In addition, Apple's relationship with SoftBank, which recently announced an acquisition of ARM Holdings, could resuscitate its relationship with the Chinese government over iBooks and iTunes. SoftBank's acquisition of ARM provides an entrance into the self-driving car market. ARM holds a 5% share of the automotive chip market, but it has a 95% share of the automotive applications processor market and 30% of the embedded intelligence market, according to the company's first-quarter roadshow presentation. One of ARM's key licensees in this area is NVIDIA. NVIDIA's DRIVE PX is the world's most advanced autonomous car platform, combining deep learning, sensor fusion and surround vision, according to the company.DRIVE PX can fuse data from 12 cameras, as well as lidar, radar and ultrasonic sensors. This allows algorithms to accurately understand the full 360-degree environment around the car to produce a robust representation, including dynamic and static objects. Didi Chuxing, the Chinese ride-hailing company formerly known as Didi Kuaidi, said in May that it received $1 billion from Apple, which was the largest single investment that the company has ever received. Didi Chuxing is Uber's biggest competitor in China, claiming 87% of the private ride-hailing market share with more than 300 million users across 400 cities.

Health news Abcellera Biologics Inc of Vancouver, disclosed its third antibody discovery collaboration with Massbiologics of the U MASS Medical School The collaboration, funded by the Defense Advanced Research Project Agency under the ADEPTPROTECT program, focuses on addressing the rapidly growing, unmet global health threat caused by the multidrug-resistant bacteria, Klebsiella pneumoniae. Abcellera will apply its single cell antibody discovery platform to identify panels of antibody candidates against Klebsiella pneumoniae directly from human volunteers. Ablexis LLC, expanded the roster of licensees of its Alivamab mouse technology to include an additional, undisclosed top-15 pharmaceutical company. This perpetual, non-exclusive license provides the licensee with its own colony of Alivamab mice and broad rights to use the mouse for antibody drug discovery and development. Ablexis will receive an eight-figure up-front payment, the company said. ABT CEO said nothing has changed regarding ALR Alere other than passage of time: CEO Miles White on call Can’t predict what will happen with ALR; ALR updated financial statement was nothing new“A fair amount” of Alere details not given; says he’s still waiting for Alere information . ABT says Alere is trying to address its challenges ABUS reports topline results from TKM-PLK1 clinical study in patients with advanced HCC Arbutus Biopharma reported topline results from the completed Phase I/II TKM-PLK1 clinical study in patients with advanced Hepatocellular Carcinoma (HCC). Arbutus intends to explore

partnership opportunities to enable further study of TKM-PLK-1 in HCC. Arbutus today reported the following topline results from the Phase I/II study of TKM-PLK1 in HCC: TKM-PLK1 was well-tolerated at all dose levels; 51% of subjects showed overall stable disease (SD) according to RECIST criteria; 22% of subjects showed an overall partial response (PR) according to Choi response criteria; Tumor density reduction of up to 59% was observed. AEGR intends to withdraw lomitapide from the European Union (EU) and certain other global markets In addition, the company is reducing approximately 13% of its global workforce. This represents a reduction from year-end 2015 of approximately 40%. As part of its plan to withdraw lomitapide from certain markets outside the U.S., Aegerion intends to evaluate its strategic options, including divestiture or licensing of Aegerion’s rights to lomitapide to a partner that can continue to provide access to the therapy for HoFH patients in need. The company will maintain certain infrastructure in the EU to support the launch of MYALEPT (metreleptin for injection) in this region upon anticipated approval in late 2017. This revised lomitapide strategy and reduction in force are part of a broad cost reduction program taken by Aegerion in response to the continuing impact of competitive therapies on JUXTAPID (lomitapide) capsules sales. The goals of the program are to significantly reduce operating expenses, extend the company’s cash position, and facilitate cash generation from operations in 2017. AET will be required to give $1 billion breakup fee to HUM if the deal breaks, NY Times article AET Aetna prepared to fight U.S. in court if sued over Humana (HUM) acquisition ALR Abbott CEO said nothing has changed regarding Alere other than passage of time: CEO Miles White on call Can’t predict what will happen with ALR; ALR updated financial statement was nothing new“A fair amount” of Alere details not given; says he’s still waiting for Alere information, ABT says Alere is trying to address its challenges AMGN PureTech Venture arms of and AMGN and MRK-KG invested in Series B financing of PureTech’s Akili Interactive, bringing total of round to $42.4m. Join existing investors which include Pfizer, Shire Akili will use the funds to support and expand clinical development of its clinical-stage products into new areas, with an expanded focus on neurodegeneration Amylyx Pharmaceuticals news that the the ALS Association in conjunction with ALS Finding a Cure, will provide a $2.96 million grant to support a phase II trial of the company’s candidate, AMX0035, in patients with amyotrophic lateral sclerosis. Expected to begin this year, the study will test the safety and tolerability of AMX0035 as well as functional outcomes. Analysis of biomarkers of cell function, neuronal damage and inflammation will be included in the trial, along with a measure of muscle strength that has been correlated with disease progression. AMX0035, which combines sodium phenylbutyrate and tauroursodeoxycholic acid, showed preliminary signs of efficacy in preclinical models. Amplitude Surgical Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “This final quarter marks the end of a year of solid growth at every level. With a particularly solid financial base, we have been able to capitalize on the assets that have driven Amplitude Surgical over many years: our ability to innovate and execute. Our Novastep subsidiary, dedicated to lower-limb solutions, recorded a particularly strong performance, with its growth accelerating quarter after quarter. We are fully confident in our ability to continue recording buoyant growth in our global sales and to consolidate our competitive positioning.” ANTM will need to pay CI a $1.85 breakup fee if the deal breaks, NY Times article Apex Therapeutics news that the FDA accepted its IND for a phase I study testing APX3330 in a group of cancer patients with solid tumors refractory to existing treatments. Once the

maximum tolerated dose is established, the drug, a small-molecule targeting the redox effector factor-1 protein, will be evaluated in a cohort of patients with pancreatic ductal adenocarcinoma, also refractory to existing treatments. APVO EBS announces Aptevo shares to begin trading today on "when issued" basis In connection with the spin-off of Aptevo Therapeutics Inc. (APVO) through a dividend distribution by Emergent BioSolutions Inc. of one share of Aptevo common stock for every two shares of Emergent common stock outstanding as of the close of business on Jul 22 2016 ARTHREX to create 560 new jobs in Florida Expansion ATNM highlights successful investigator meeting for pivotal Phase 3 Iomab-B SIERRA trial Announced that the company conducted a successful investigator meeting on Jul 15 2016 in Dallas, Texas. The purpose of the investigator meeting was to bring together bone marrow transplant physicians, care providers and clinical research coordinators from current and prospective clinical trial sites in the pivotal, Phase 3 SIERRA clinical trial for Iomab-B. Members of Actinium's scientific advisory board, clinical development team and management team presented educational content pertaining to Iomab-B and the SIERRA trial to the meeting attendees. Actinium was joined by members of MedPace, Inc., Actinium's Clinical Research Organization (CRO) for the SIERRA trial. The meeting drew over 85 attendees including principal investigators, care providers and clinical research coordinators from many of the leading bone marrow transplant centers from across the United States. Management comments: Felix Garzon, M.D., Ph.D., Actinium's SVP and Head of Clinical Development said, "The Investigator Meeting furthers our confidence in our ability to successfully execute the pivotal Phase 3 trial for Iomab-B. It was clear from the meeting that there is great enthusiasm from transplant, nuclear medicine and hematology physicians for Iomab-B. Actinium's clinical development team is excited to work with these physicians to progress the SIERRA trial efficiently and effectively." Sandesh Seth, Actinium's Executive Chairman stated, "I am delighted by the attendance and enthusiasm that I witnessed at the Investigator Meeting this past weekend. Actinium is fortunate to have such strong support from the leading bone marrow transplant centers, which we can only attribute to the potential for Iomab-b to fulfill a dire unmet medical need as an induction and conditioning agent prior to a bone marrow transplant for patients with relapsed or refractory Acute Myeloid Leukemia who are over the age of 55. We are thankful for the physicians and centers that will be participating in our trial but most importantly we are grateful for the opportunity to be able to provide such a potentially life saving therapy to patients who currently have no viable treatments available." AVXS the FDA has granted Breakthrough Therapy Designation for AVXS-101, the company’s lead development candidate for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients. The Breakthrough Therapy Designation is based on preliminary clinical results from the ongoing trial of AVXS-101, conducted in collaboration with The Research Institute at Nationwide Children’s Hospital and The Ohio State University. AZN can’t stop generic-drug makers from bringing cheaper rivals of its best-selling medicine, the cholesterol fighter Crestor, to the U.S. market.A federal judge in Washington, D.C., refused the company’s request for a temporary ban on the generics Tuesday and, barring an appeal, his ruling means generic drugmakers may now enter the market for a drug that generated more than $5 billion in global sales for London-based AstraZeneca last year.Sales of the name-brand drug are likely to plunge 30 percent to $3.5 billion this year as cheaper alternatives become available

BAYER is “disappointed” in Monsanto’s decision to reject increased offer of $125 per share. Says looking forward to continued dialogue with Monsanto Bayer reaffirmed offer would not be subject to a financing condition and offered $1.5b reverse antitrust break fee BEAT notes favorable ruling in patent case BEAT announced that the District Court in the District of Massachusetts has entered a 14-Jul-16 Consent Judgment permanently enjoining and restraining InfoBionic, Inc. from “making, using, offering to sell, or selling within the United States or importing into the United States” any of its “First-Generation” MoMe Kardia system and from “engaging in any other act of infringement” by its “First-Generation” system as defined under federal patent law. BioTelemetry is pleased with this initial result, and has pending patent infringement claims against InfoBionic’s “Second-Generation” MoMe Kardia system as well as claims for misappropriation of BioTelemetry’s trade secrets. BioTelemetry has asserted that such trade secrets were misappropriated, in part, by one or more former BioTelemetry executives and employees who joined InfoBionic and were involved in the development of its MoMe Kardia system. BLCM announces patent on CaspaCIDe method for selectively eliminating therapeutic cells BLCM announced that U.S. patent 9,393,292 has issued to Baylor College of Medicine for a method of cell therapy that enables the selective elimination of administered cells that have been modified to express an inducible caspase-9 protein (iCasp9). Bellicum, which exclusively licensed the worldwide rights to the invention from BCM, has incorporated this method into its CaspaCIDe platform. The patent relates to the on-demand in vivo elimination of therapeutic cells, (such as CAR T, TCR and stem cells) that have been modified to express the iCasp9 protein. The newly issued patent is scheduled to expire in 2031. BMY announces commercial launch of the ORENCIA ClickJect Autoinjector, a new self-administered autoinjector for adults with moderate to severe rheumatoid arthritis (RA). The ORENCIA ClickJect delivers 125 mg of subcutaneous (SC) ORENCIA with push button operation and injection confirmation, which may reduce the possibility of user errors. BSX enters Stipulation of Settled Issues with the IRS -- 8-K On Jul 19 201616, Boston Scientific Corporation , entered into a Stipulation of Settled Issues with the Internal Revenue Service intended to resolve all disputes related to the previously disclosed transfer BSX plans $275m IRS Settlement on Guidant Issues-- Boston Scientific in accord with IRS to settle transfer pricing issues for Guidant’s 2001-2006 tax years and Boston Scientific’s 2006 and 2007 tax years.If settlement finalized, Boston Scientific to make $275m net tax payments to IRS plus interest, BSX had previously recorded enough reserves to resolve issue, BSX sees no change to 2016 estimated tax rate Carbon Black acquired Confer, an anti-virus company based in Southborough.Carbon Black, which has 2,000 customers, said the addition of Confer would allow the firm to take direct aim at products developed by rivals SYMC and PANW.“With the acquisition of Confer, organizations of every size can now address their endpoint-security requirements through a single platform,” said Patrick Morley, CEO of Carbon Black, in a statement. “This extension of the Carbon Black platform is a significant step forward in our vision to create a world safe from cyber attacks.”Confer, founded in 2013, has raised a total of $25 million in funding, according to Crunchbase. Carbon Black has raised more than $170 million from such investors as Cambridge-based venture firm Accomplice, as well as existing investors .406 Ventures, Blackstone, Highland Capital Partners, Kleiner Perkins Caufield & Byers, and Sequoia Capital and new investors Evolution Equity and Founders Circle.Carbon Black has more than 600

employees, while Confer has 50.Carbon Black is also reportedly seeking to go public. reported that Morgan Stanley and JPMorgan Chase & Co. will lead the initial public offering, with an IPO coming as soon as this year CERC announces $1M grant from NIH CERC announced that it has been awarded a grant (award number U44AA025253) from the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health. The grant of $1.0M provides Cerecor with additional resources to progress the development of CERC-501 for the treatment of alcohol use disorder. Upon successful completion of the development activities covered under this grant, Cerecor will have the opportunity to apply for continued funding. Chronos Therapeutics Ltd acquired three preclinical development programs for central nervous system diseases (fatigue in multiple sclerosis, addictive behaviors, and possibly post-traumatic stress disorder) from a subsidiary of SHPG Shire. The deal covers all components of those programs on a worldwide basis. Shire is now a strategic equity investor in Chronos, making Shire eligible for milestone payments on product sales. Financial terms were not disclose Clinigen Brexit is not expected to have any adverse effects on the group in the short term. Whilst the outcomes are not yet clear, the group's flexible operating model, the team's deep understanding of multinational regulatory process and with around 85% of revenues being from International markets, it is expected that any medium to long term implications will be manageable. Overall the group has traded in line with the board's expectations and all divisions are well positioned for good growth next year. CI ANTM will need to pay CI a $1.85 breakup fee if the deal breaks, NY Times article DOW DD shareholders approve merger DD DOW shareholders approve merger EBS announces Aptevo shares to begin trading today on "when issued" basis In connection with the spin-off of Aptevo Therapeutics Inc. (APVO) through a dividend distribution by Emergent BioSolutions Inc. of one share of Aptevo common stock for every two shares of Emergent common stock outstanding as of the close of business on Jul 22 2016 EIGR completes dosing in Phase 2 LOWR HDV - 3 study Eiger announced the completion of dosing of LOWR HDV – 3 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 3) at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. Twenty-one patients with chronic hepatitis delta were randomized into one of six treatment groups. FlexDex Surgical said today that it raised a $5 million Series B round it plans to use to advance the laparoscopic surgery tools it’s developing.The round was led by current investors, including co-founders technology chief Shorya Awtar, chief marketing officer Greg Bowles and Dr. James Geiger of the University of Michigan; plus board members, individual backers and distributors, Brighton, Mich.-based FlexDex said.The proceeds are earmarked for commercializing the FlexDex needle driver and for the development of a second-generation device. The company said it also plans to use the cash to develop a catalog of laparoscopic instruments.”Awtar, Bowles and Geiger founded FlexDex in 2014 to commercialize technology they developed at UMich, based on their research into parallel kinematics, virtual center of rotation, and flexure mechanisms at the school’s Precision Systems Design Lab, according to the company’s website. The goal is a line of instruments with intuitive, one-to-one mapping of the surgeon’s movements that are more precise and cause less fatigue than older technology Hikma starts sale of generic Xeloda tablets in U.S.

HIIQ Health Insurance Innovations names Gavin Southwell as president and also HIIQ discloses examination by Indiana Dept. of Insurance The company has received notification from the Indiana Department of Insurance that a multistate examination has been commenced providing for the review of HCC Life Insurance Company’s short term medical plans, Affordable Care Act compliance, marketing, and rate and form filing for all products. As the company is a distributor of HCC products, the notification indicated that the multistate examination will include a review of the activities of the company and a review of whether the company’s practices are in compliance with Indiana insurance law and the similar laws of other states participating in the examination. HLTH discussed on Life Sciences Report, Kenneth Efird will oversee Nobilis Health Corp.'s) operating units across the nation, focusing on execution of the company's strategic plan, according to a press release issued on July 11. Prior to stepping in as president, Efird had served as chief operating officer and chief business development officer at Nobilis, which operates surgical hospitals, physician practices and ambulatory surgical centers in Texas and Phoenix.Neil Maruoka, an analyst with Canaccord Genuity who initiated coverage on Nobilis on July 13, pointed out that Athas, the company's "marketing arm," is "a key differentiator and organic growth engine.Through its targeted marketing, we believe that Athas has the ability to drive higher case volumes and higher revenue per procedure through Nobilis' facilities." Hookipa Biotech AG,of Vienna started a 15-month phase I study of HB-101, its vaccine candidate against human cytomegalovirus (CMV). A total of 54 healthy subjects will be enrolled and will receive the vaccine or placebo administered intramuscularly at day zero, month one and month three. The primary endpoint is safety. Interim immunogenicity data are expected in the last quarter of this year and first quarter of 2017. HTGM obtains CE IVD Mark for HTG EdgeSeq DLBCL and HTG EdgeSeq system The company has obtained CE-IVD marking for its HTG EdgeSeq DLBCL Cell of Origin Assay and next-generation sequencing (NGS) based HTG EdgeSeq system. HUM AET will be required to give $1 billion breakup fee to HUM if the deal breaks, NY Times article Ichor Medical Systems news for Scancell Holdings who said its option to license the Trigrid electroporation delivery system developed by Ichor Medical Systems was extended for a second time, until July 13, 2018, for use with SCIB1, its ImmunoBody vaccine to treat melanoma. In exchange, Scancell granted a partial waiver over the lock-up that prohibited the sale, during the two years following their issue, of approximately 3.2 million ordinary shares issued to Ichor in a second tranche as partial payment for the license option. Last month, Scancell reported that it scrapped a supply of SCIB1, a DNA-based cancer vaccine, after routine testing showed the clinical material no longer conformed to its original specification INCY granted FDA Orphan Drug Status for Ruxolitinib For acute lymphoblastic leukemia ALL InnFocus Inc news that Santen will acquire privately held InnFocus, developer of the InnFocus MicroShunt® (hereinafter, "MicroShunt") glaucoma implant device.InnFocus is developing the MicroShunt implant to lower and sustain intraocular pressure (IOP) for the treatment of primary open-angle glaucoma (mild to severe stage disease). The MicroShunt has shown significant and sustainable lowering of IOP when used alone or in combination with cataract surgery in clinical trials outside of the U.S. Late stage clinical studies are underway in the U.S. and Europe in advance of PMA (Pre-Market Approval) application to the U.S. Food and Drug Administration (FDA) planned in the near future. The MicroShunt has received CE Mark in Europe."With this

acquisition, Santen will strengthen our glaucoma pipeline and stay at the forefront of innovation in ophthalmology. This agreement is in line with our long term vision to become a Specialized Pharmaceutical Company with a Global Presence. I am truly excited about the MicroShunt as a new and effective treatment option that should significantly improve patient outcomes," said Akira Kurokawa, President and CEO of Santen."The InnFocus MicroShunt was developed to be the world's first minimally invasive stand-alone procedure for mild, moderate and severe stage primary open angle glaucoma. In addition to reducing IOP, the MicroShunt does not require simultaneous cataract removal, unlike many MIGS (micro-invasive glaucoma surgery) technologies. The InnFocus team is very pleased to be joining Santen and its global effort to address this growing and important segment of the ophthalmic market," said Randy Lindholm, Executive Chairman of the Board of InnFocus. JNJ announces health Canada approves IMBRUVICA for first-line treatment of chronic lymphocytic leukemia Janssen Inc. announced that Health Canada has approved IMBRUVICA (ibrutinib) an oral, once-daily, single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukemia (CLL). JNJ Health Canada approves INVOKAMET for the treatment of adults with type 2 diabetes J&J's Janssen Inc. announced that INVOKAMET, a twice daily fixed-dose therapy combining INVOKANA (canagliflozin) and metformin hydrochloride into a single tablet, for the treatment of adults with type 2 diabetes is now available in Canada JNJ in terms of mergers and acquisitions, Caruso said, “Our strategy in pharma is licensing and collaborations and not major acquisitions. That doesn’t mean we’re not going to do one.”, article on Biospace JNP appoints Alicia Secor President and CEO She joins Juniper from Zafgen, Inc., where she served as Chief Commercial Officer and played a key role in advancing the company to a Phase 3 pre-commercialization status. LCI announces receipt of FDC acceptable filing letter for Fentanyl patch ANDA The company's strategic partner, Sparsha Pharma USA, Inc., has received an Acceptable for Filing letter from the FDA of its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. LLY NICE has published final draft guidance which recommends pemetrexed (Alimta) for some people with lung cancer. As part of the reappraisal the manufacturer agreed to provide pemetrexed at a discounted price to the NHS and also submitted additional cost effectiveness analyses. This meant that pemetrexed could now be considered a cost-effective use of NHS resources. The final draft guidance is now with consultees, who have the opportunity to appeal against the decision. The final guidance is expected in August. Lonza and RDUS in 6 year manu agreement on Jul 13 2016 effective Jun 28 2016 to manufacture commercial supply of active pharmaceutical ingredient for abaloparatide (API)RDUS to purchase API in batches at price per gram in euros, subject to an annual increase by Lonza Agreement has initial term of six yrs, will automatically renew for successive 3-yr terms unless either party provides notice of non-renewal 24 mos. before end of then-current term Both parties entered into development and manufacturing agreement in 2007 where Lonza provided API for clinical development MDT c receives FDA clearance for cement-augmented pedicle screws MDT announced FDA 510(k) clearance of the CD Horizon Fenestrated Screw Set, which can be used for patients

diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first U.S. clearance for cement-augmented pedicle screws. Mithra says Canada approves Estelle Clinical Trial Application MON BAYER is “disappointed” in Monsanto’s decision to reject increased offer of $125 per share. Says looking forward to continued dialogue with Monsanto Bayer reaffirmed offer would not be subject to a financing condition and offered $1.5b reverse antitrust break fee Mount Tam Biotechnologies Inc. and the Buck Institute for Research on Aging, have amended a license and collaboration agreement to settle an outstanding debt that the company owed the institute. Mount Tam paid $51,706 in exchange for extinguishing $326,796 in obligations to the institute under the deal, settling all outstanding payments owed to Buck. The agreement also temporarily halts a research collaboration between the parties until Mt. Tam secures $2 million in financing. After that, the collaboration will restart for a period of 21 months with the possibility of extension. Additionally, the agreement expanded the field of use for licensed compounds in the collaboration to any and all conditions, human and veterinary. Mt. Tam’s field had been restricted to autoimmune disorders, in which it is developing TAM-01 for the treatment of systemic lupus MRK-KG PureTech Venture arms of Merck KGaA and Amgen invested in Series B financing of PureTech’s Akili Interactive, bringing total of round to $42.4m. Join existing investors which include Pfizer, Shire Akili will use the funds to support and expand clinical development of its clinical-stage products into new areas, with an expanded focus on neurodegeneration MYL AZN can’t stop generic-drug makers from bringing cheaper rivals of its best-selling medicine, the cholesterol fighter Crestor, to the U.S. market.A federal judge in Washington, D.C., refused the company’s request for a temporary ban on the generics Tuesday and, barring an appeal, his ruling means generic drugmakers may now enter the market for a drug that generated more than $5 billion in global sales for London-based AstraZeneca last year.Sales of the name-brand drug are likely to plunge 30 percent to $3.5 billion this year as cheaper alternatives become available. MYL launched generic Crestor Tablets earlier in the day Nascent Biotech news that Zhejiang Hisun Pharma in-licensed China rights to pritumumab, a epithelial cancer mAb being developed by Nascent Biotech of Florida. Epithelial cancers include cancers of the brain, pancreas, colon, lung and breast. Nascent has not yet filed for US clinical trials of pritumumab, though it expects to complete a Phase I trial in the next 12 to 18 months. Hisun will have exclusive China rights to pritumumab, including manufacturing NVS braced for tough US pricing after presidential poll, NVS has taken a number of restructuring steps in the past six months to shift from a loosely affiliated set of division where there is heavy duplication in back office functions to a fully integrated company. He suggested the EU vote on Brexit would have little impact on NVS, Jimenez confirmed that they were looking for an opportunity to sell their $ 14 billion stake in RHHBY, article in FT NVS has stopped making tuberculosis drugs in Pakistan in a dispute over pricing, prompting fears of a health crisis due to a shortage of drugs in a country with the world's fifth-highest TB rates. As in many developing countries, the Drug Regulatory Authority of Pakistan (DRAP) sets prices for about 320 critical medicines. But pricing caps have not been significantly raised since 2001, making it unviable for firms to make many of the drugs to continue supplying the drugs NVTA Invitae announces new Breast Cancer STAT Panel The company now offers a new Breast Cancer STAT Panel of high-quality genetic testing designed for breast cancer patients whose providers need a fast turnaround time to guide treatment and management Invitae’s new

Breast Cancer STAT Panel includes seven genes with surgical and therapeutic relevance: BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11, and TP53 OGEN Oragenics Inc., of Tampa, Fla., said the NYSE accepted its plan for regaining compliance. Oragenics has until Nov. 10, 2017, to regain compliance or make acceptable progress following its plan. The company’s stock will continue to trade on the exchange as OGEN.BC, and will be reviewed on a regular basis by NYSE regulators. Oncorus Inc raised $57 million in a series A financing for its immunotherapy platform, designed to attack such cancers as glioblastoma. The platform uses what’s described as a next-generation oncolytic herpes simplex virus. Precision Ocular Ltd., of Oxford, U.K., said V-Bio Ventures had joined investors in the company’s series A financing, which has raised £15.5 million (US$20.3 million) in all from investors Imperial Innovations, Consort Medical plc, Neomed and Hovione Scientia Ltd., along with V-Bio. The oversubscribed financing will be used to develop programs to treat retinal diseases such as age-related macular degeneration and diabetic macular edema, as well as rare and orphan indications. The funds will also enable the development of next-generation ocular drug delivery systems designed to administer cell and gene therapies to the back of eye Investors were led by MPM Capital (with equal contributions from MPM BV2014 and the Oncology Impact Fund), and included Deerfield Management, Arkin Bio Ventures, Summit, N.J.-based Celgene Inc., Excelyrate Capital, Long March Investment Fund and MPM’s Sunstates Fund. Oncbiomune Pharmaceuticals has developed a mouse model to test an autologous whole cell mouse mammary cancer vaccine. When the mice are vaccinated with a series of whole cell preparations of mouse mammary carcinoma cells combined with granulocyte macrophage colony-stimulating factor and interleukin-2 and then transplanted with the same tumor cells, the growth of the cancerous tumor is significantly inhibited, the company said. Proscavax, the company’s experimental prostate cancer vaccine, which is built upon the same platform, is currently being evaluated in a phase I trial in prostate-specific antigen recurrent prostate cancer in both hormone-naïve and hormone independent patients in the U.S. A phase II/III trial of prostate cancer patients with biochemical progression is expected to begin in Mexico this current quarter, followed by a phase II trial of prostate cancer patients in active surveillance in the U.S. ONVO on track to commercialize kidney tissue in Q3 of 2016 Organovo Holdings announced that it is on track to commercialize its second tissue, the kidney proximal tubule, in the third calendar quarter of 2016. As part of its pre-commercialization activities, Organovo introduced an early access program for preferred partners and has signed the first customer orders to study the effects of drug exposure on the kidney proximal tubule. The company has also actively engaged with additional biopharmaceutical companies, indicating strong interest in this program and its kidney tissue. Peptidream non exclusively licensed its Peptide Discovery Platform System (PDPS) technology to Genentech RHHBY. Under the terms of the agreement, Peptidream will receive an undisclosed up-front payment, annual technology access payments, and is eligible to receive development milestone payments. In addition, Peptidream is eligible to receive royalties on sales of certain products that arise from use of the PDPS technology. The companies will continue to work together to identify macrocyclic/constrained peptides against multiple targets of interest selected by Genentech, and to optimize hit peptides into therapeutic peptides or small molecule products using the technology under a December 2015 agreement.

PHG has acquired Georgia-based Wellcentive, a U.S. population health management technology company. Wellcentive employees will join Phillips' Population Health Management business group, which will be led by CEO Tom Zajac, according to the release. The acquisition is part of a partnership trend among healthcare organizations some of which are targeted at supporting population health initiatives and expanding health IT services. Earlier this month, for example, Princeton HealthCare System and Pennsylvania Health System signed a letter of intent for a partnership for such purposes. These deals come as a result of new quality of care requirements and reimbursement models that have gone from fee-for-service focused to being tied to the value of care provided. “With this strategic acquisition, we will strengthen our Population Health Management business and its leadership, as health systems gradually shift from volume to value-based care, and provide more preventative and chronic care services outside of the hospital,” Philips CEO of Connected Care & Health Informatics Jeroen Tas said in a statement, adding, “Wellcentive’s solutions will provide our customers with the ability to collect data from large populations, detect patterns, assess risks and then deploy care programs tailored to the needs of specific groups.”Wellcentive’s cloud-based IT solutions that have the ability of importing, aggregating, and analyzing clinical, claims, and financial data will become part of Philips' HealthSuite cloud under the agreement. Portage Biotech Biohaven unit started dosing subjects in the first study testing the pharmacokinetics and safety of BHV-4157. The study will explore a range of doses and results that will guide dosing in the upcoming randomized controlled trial of BHV-4157 in patients with spinocerebellar ataxia (SCA), a rare, debilitating neurodegenerative disorder. Subject to those results, Biohaven plans to initiate a pivotal phase III trial in SCA before the end of the year. BHV-4157, a prodrug of the firm’s glutamate-modulating candidate, BHV- 0223, has orphan status in SCA. Precision Ocular Ltd said V-Bio Ventures had joined investors in the company's series A financing, which has raised £15.5 million (US$20.3 million) in all from investors Imperial Innovations, Consort Medical plc, Neomed and Hovione Scientia Ltd and V-Bio. Promis Neurosciences initiated a program to identify new therapeutic targets on neurotoxic strains of the protein TDP43, implicated in the development of amyotrophic lateral sclerosis and frontotemporal dementia. PSDV notes presentation of preclinical data regarding Tethadur tech PSDV announced that new data from preclinical studies of pSivida’s Tethadur bioerodible technology platform were presented at the 2016 Annual Meeting & Exposition of the Controlled Release Society: The Tethadur biodegradable matrix was loaded with the monoclonal antibody Avastin at a high payload of approximately 24% w/w. The release of Avastin from the Tethadur matrix was linear over 50 time points following a low initial burst of only 12%. Avastin retained a high activity level at its release from Tethadur of over 80% at 30 time points. The dissolution of the Tethadur matrix into silicic acid was also linear over 50 time points PTCT NICE publishes its final guidance recommending PTC Therapeutics' ataluren (Translarna) for treating children with Duchenne muscular dystrophy Under the terms of the managed access agreement between the company and NHS England, the usual 3-month funding period has been waived by NHS England, meaning ataluren could be available for those who need it within weeks. As part of the agreement the usual 3-month funding period has been waived by NHS England, meaning ataluren could be available within weeks. Reference Link

PureTech Venture arms of Merck KGaA and Amgen invested in Series B financing of PureTech’s Akili Interactive, bringing total of round to $42.4m. Join existing investors which include Pfizer, Shire Akili will use the funds to support and expand clinical development of its clinical-stage products into new areas, with an expanded focus on neurodegeneration RDUS and Lonza in 6 year manu agreement on Jul 13 2016 effective Jun 28 2016 to manufacture commercial supply of active pharmaceutical ingredient for abaloparatide (API)RDUS to purchase API in batches at price per gram in euros, subject to an annual increase by Lonza Agreement has initial term of six yrs, will automatically renew for successive 3-yr terms unless either party provides notice of non-renewal 24 mos. before end of then-current term Both parties entered into development and manufacturing agreement in 2007 where Lonza provided API for clinical development Resverlogix dosing has commenced in a Phase 1 PK study with lead drug candidate apabetalone (RVX-208) in patients with severe renal impairment. The primary objective of the Phase 1 study, based in New Zealand, is to determine if apabetalone treated patients with severe renal impairment have the same favorable PK traits as has been witnessed in previous apabetalone trials. Results are expected in H2 of 2016, and if successful, will allow for more advanced renal impairment and dialysis trials to proceed. The study will also explore acute changes in biomarkers relevant to Bromodomain and Extra-Terminal (BET) inhibition in subjects with severe renal impairment. RHHBY news for Peptidream who non exclusively licensed its Peptide Discovery Platform System (PDPS) technology to Genentech RHHBY. Under the terms of the agreement, Peptidream will receive an undisclosed up-front payment, annual technology access payments, and is eligible to receive development milestone payments. In addition, Peptidream is eligible to receive royalties on sales of certain products that arise from use of the PDPS technology. The companies will continue to work together to identify macrocyclic/constrained peptides against multiple targets of interest selected by Genentech, and to optimize hit peptides into therapeutic peptides or small molecule products using the technology under a December 2015 agreement. RHHBY Jimenez confirmed that they were looking for an opportunity to sell their $ 14 billion stake in RHHBY, article in FT and on NVS earnings call Jul 19 2016 Santen Pharmaceutical and InnFocus Inc announced that the two companies have entered into a definitive agreement under which Santen will acquire privately held InnFocus, developer of the InnFocus MicroShunt® (hereinafter, "MicroShunt") glaucoma implant device.InnFocus is developing the MicroShunt implant to lower and sustain intraocular pressure (IOP) for the treatment of primary open-angle glaucoma (mild to severe stage disease). The MicroShunt has shown significant and sustainable lowering of IOP when used alone or in combination with cataract surgery in clinical trials outside of the U.S. Late stage clinical studies are underway in the U.S. and Europe in advance of PMA (Pre-Market Approval) application to the U.S. Food and Drug Administration (FDA) planned in the near future. The MicroShunt has received CE Mark in Europe."With this acquisition, Santen will strengthen our glaucoma pipeline and stay at the forefront of innovation in ophthalmology. This agreement is in line with our long term vision to become a Specialized Pharmaceutical Company with a Global Presence. I am truly excited about the MicroShunt as a new and effective treatment option that should significantly improve patient outcomes," said Akira Kurokawa, President and CEO of Santen."The InnFocus MicroShunt was developed to be the world's first minimally invasive stand-alone procedure for mild, moderate and severe stage primary open angle glaucoma. In addition to reducing IOP, the

MicroShunt does not require simultaneous cataract removal, unlike many MIGS (micro-invasive glaucoma surgery) technologies. The InnFocus team is very pleased to be joining Santen and its global effort to address this growing and important segment of the ophthalmic market," said Randy Lindholm, Executive Chairman of the Board of InnFocus.Under the terms of the agreement, Santen will acquire InnFocus for an upfront payment of USD 225 million, plus performance based consideration upon achievement of certain development, regulatory and commercial milestones. Sapience Therapeutics Inc., has exclusively licensed from Columbia University a transcription factor 5 inhibitor, for the potential treatment cancers, possibly including glioblastoma and neuroblastoma. Once administered, the candidate, called ST-36, prevents the activation of these genes in tumors, resulting in tumor-specific cell death, the company said. Financial terms of the agreement were not disclosed Scancell Holdings said its option to license the Trigrid electroporation delivery system developed by Ichor Medical Systems was extended for a second time, until July 13, 2018, for use with SCIB1, its ImmunoBody vaccine to treat melanoma. In exchange, Scancell granted a partial waiver over the lock-up that prohibited the sale, during the two years following their issue, of approximately 3.2 million ordinary shares issued to Ichor in a second tranche as partial payment for the license option. Last month, Scancell reported that it scrapped a supply of SCIB1, a DNA-based cancer vaccine, after routine testing showed the clinical material no longer conformed to its original specification SHPG news for Chronos Therapeutics Ltd who acquired three preclinical development programs for central nervous system diseases (fatigue in multiple sclerosis, addictive behaviors, and possibly post-traumatic stress disorder) from a subsidiary of SHPG Shire. The deal covers all components of those programs on a worldwide basis. Shire is now a strategic equity investor in Chronos, making Shire eligible for milestone payments on product sales. Financial terms were not disclose SPNC Spectranetics comments on Appeals Court ruling Earlier today, the Appeals Court ordered dismissal of state-law claims in Spectranetics subsidiary AngioScore's litigation with TriReme et al over angioplasty balloon catheters The company remains confident in the merits of the case and is currently evaluating next steps. No part of the potential financial award associated with this matter has been previously reflected in the company’s financial statements. Spectranetics acquired AngioScore in June 2014. SPNC announces presentation of final 12-month results of the Stellarex drug-coated Balloon’s ILLUMENATE European Randomized Clinical Trial The ILLUMENATE European Randomized Clinical Trial enrolled more than 300 patients suffering from peripheral arterial disease. The study results will be available sooner than previously anticipated and will be presented for the first time at Amputation Prevention Symposium (AMP) Aug 10 2016 Synaffix BV of Amsterdam, said preclinical studies showed that its platform technologies, Glycoconnect and Hydraspace, generated antibody drug conjugates (ADCs) with improved therapeutic index in comparison to the ADCs Kadcyla (trastuzumab emtansine,RHHBY and SGEN Adcetris brentuximab vedotin, approved by the FDA to treat HER2-positive breast cancer and multiple lymphoma indications Synthorx synthetic biology startup that expanded the number of DNA base pairs with two synthetic nucleotides raised $10 million in a Series B financing round led by RA Capital Management, The company plans to use the proceeds to double its headcount (from eight to

16), and to finance the development of new protein-based drugs that incorporate at least one synthetic amino acid.In its quest to develop new biologics, Synthorx has focused on potential products for treating pain, metabolic disease, and infectious diseases, Turner said.T Synthorx technology is based on research led by Floyd Romesberg, a biological chemist at The Scripps Research Institute. In addition to the four standard nucleotides that comprise DNA (designated as A, C, T, and G), Romesberg’s team showed that a novel synthetic DNA base pair (X and Y) could be inserted into bacterial DNA that reproduced with no change in the altered DNA.The initial goal at Synthorx, Turner said, was to use the techniques developed in Romesberg’s lab to insert synthetic DNA into E. coli bacteria and to make proteins that incorporate synthetic amino acids. The groundbreaking potential of Synthorx’s technology is the ability to insert synthetic DNA in bacteria and efficiently produce proteins with multiple synthetic amino acids at low cost and at sufficient scale for drug discovery and development. “We are the only company where you can add synthetic amino acids to any size protein or peptide and produce it at scale,” Turner said. Synthorx also has been meeting with pharmaceutical companies that have developed protein therapeutics that stalled, and could possibly be optimized using Synthorx’s technology.Synthorx will add a chief science officer as well as a chief business officer in coming months TBIO Transgenomic licenses commercial rights to Long QT syndrome DNA testing portfolio to LabCorp (LH) TBIO announced that it has signed a commercial license agreement with Laboratory Corporation of America Holdings for TBIO’s portfolio of intellectual property pertaining to DNA susceptibility testing for Long QT syndrome, a primarily congenital heart rhythm disorder that is associated with potentially lethal cardiac arrhythmias UN agreed to buy Dollar Shave Club LLC, in a deal said to be worth about $1 billion, giving it a piece of the fast-growing business of selling grooming products online by subscription. The deal close subject to regulatory approval, in the third quarter, Unilever said in a statement, without disclosing terms. The company will pay cash, said people familiar with the terms, who asked not be identified as the valuation hasn’t been disclosed. Merlin Koene, a spokesman for Unilever, declined to comment. Viracor-Ibt Laboratories received emergency use authorization from the FDA for its Zika virus real-time RT-PCR assay. The company will perform the assay under Clinical Laboratory Improvement Amendments/College of American Pathologists regulations for high-complexity clinical laboratories. Zhejiang Hisun Pharma in-licensed China rights to pritumumab, a epithelial cancer mAb being developed by Nascent Biotech of Florida. Epithelial cancers include cancers of the brain, pancreas, colon, lung and breast. Nascent has not yet filed for US clinical trials of pritumumab, though it expects to complete a Phase I trial in the next 12 to 18 months. Hisun will have exclusive China rights to pritumumab, including manufacturing XOMA receives orphan drug designation in the European Union for XOMA 358 for treatment of congenital hyperinsulinism XOMA announced the European Medicines Agency (EMA) has granted Orphan Drug Designation to XOMA 358 for the treatment of congenital hyperinsulinism (CHI), a rare genetic disorder in which the insulin cells of the pancreas (beta cells) secrete inappropriate and excessive insulin. XOMA 358 is a negative allosteric antibody that binds to the insulin receptor and down-regulates insulin action. It is in Phase 2 development for CHI with clinical sites in the United States and European Union (EU) actively enrolling patients.

Misc

Nextech Invest Ltd. of Zurich, said it closed its $64 million Oncology Fund IV with limited partners based in the U.S., Europe and Asia. The fund has already made investments in Peloton Therapeutics Inc., of Dallas, which is currently in clinical testing with small-molecule HIF-2 alpha antagonist in kidney cancer and other diseases; Kura Oncology Inc., of La Jolla, Calif., studying its lead molecule tipifarnib in multiple phase II studies based on findings in cancer genetics; and immuno-oncology company Jounce Therapeutics Inc., of Cambridge, Mass., which is leveraging its translational science platform to develop targeted immunotherapies.

STAT From an itchy nose to a scratchy sunburn, new research indicates that our various kinds of itch share common roots. Previously, scientists thought that two calcium channels — TRPV4 and TRPV1 — each controlled one type of itch sensation. But in a new study in mice they’ve discovered that’s not the case. “The interesting part is that two different channels work in concert to transmit itch information,” study author Zhou-feng Chen of Washington University in St. Louis told me. Chen and her colleagues hope that cutting back the function of either channel could provide a target for anti-itch therapies. From an itchy nose to a scratchy sunburn, new research indicates that our various kinds of itch share common roots. Previously, scientists thought that two calcium channels — TRPV4 and TRPV1 — each controlled one type of itch sensation. But in a new study in mice they’ve discovered that’s not the case. “The interesting part is that two different channels work in concert to transmit itch information,” study author Zhou-feng Chen of Washington University in St. Louis Chen and her colleagues hope that cutting back the function of either channel could provide a target for anti-itch therapies. This morning, biochemist Kevin Esvelt brings his idea to eradicate Lyme disease by releasing genetically modified mice to Martha's Vineyard. It's also an experiment in getting a community involved in science that would have large effects on shared environments. The MIT professor will meet in the morning with health staff from the Vineyard's different towns. Esvelt will spend the afternoon with the public in a town hall, to see if they would be interested in participating in this project. Esvelt gave a similar presentation on Nantucket last month.

Rare Disease Report The Amyloidosis Research Consortium has concluded that NT-proBNP response is a valid outcome measure for predicting survival in AL amyloidosis patients. That conclusion is posted in the pivotal paper published in the journal Leukemia and can be accessed here. AL amyloidosis is an ultra-rare, progressive and fatal disease characterized by the accumulation of abnormal, misfolded protein (amyloid) in various tissues and organs. This amyloid protein builds up in the heart, kidneys, liver, soft tissue, and nervous system, resulting in multiorgan failure and death. Up to 70% AL amyloidosis patients have accumulations of amyloid in cardiac tissue that will lead to cardiomyopathy and ultimately to death. No therapies have been approved for the treatment of patients with AL amyloidosis.

KHN News California Healthline and Kaiser Health News: "California’s Obamacare premiums will jump 13.2 percent on average next year, a sharp increase that is likely to reverberate nationwide in an election year. The Covered California exchange had won plaudits by negotiating 4 percent average rate increases in its first two years. But that feat couldn’t be repeated for 2017, as

overall medical costs continue to climb and two federal programs that help insurers with expensive claims are set to expire this year

Cramer Pet care feature: Cramer looked at Zoetis (ZTS), Idexx Labs (IDXX), VCA (WOOF), and PetMed Express (PETS). Cramer would recommend buying Idexx Labs on weakness, and is bullish on VCA. He would wait for another strong quarter from Zoetis before buying. Cramer believes PetMed Express however, has limited upside.

Xconomy on Synthorx Synthorx synthetic biology startup that expanded the number of DNA base pairs with two synthetic nucleotides, said raised $10 million in a Series B financing round led by RA Capital Management, the Boston life sciences hedge fund.Existing investors Avalon Ventures and Correlation Ventures joined in the round. The San Diego firms have invested $6 million since 2014, when Synthorx was founded, CEO Court Turner said yesterday. An unnamed pharmaceutical company also is providing additional undisclosed funding under a drug development deal signed in Februaryhe company plans to use the proceeds to double its headcount (from eight to 16), and to finance the development of new protein-based drugs that incorporate at least one synthetic amino acid.In its quest to develop new biologics, Synthorx has focused on potential products for treating pain, metabolic disease, and infectious diseases, Turner said.T Synthorx technology is based on research led by Floyd Romesberg, a biological chemist at The Scripps Research Institute. In addition to the four standard nucleotides that comprise DNA (designated as A, C, T, and G), Romesberg’s team showed that a novel synthetic DNA base pair (X and Y) could be inserted into bacterial DNA that reproduced with no change in the altered DNA.The initial goal at Synthorx, Turner said, was to use the techniques developed in Romesberg’s lab to insert synthetic DNA into E. coli bacteria and to make proteins that incorporate synthetic amino acids. The groundbreaking potential of Synthorx’s technology is the ability to insert synthetic DNA in bacteria and efficiently produce proteins with multiple synthetic amino acids at low cost and at sufficient scale for drug discovery and development. “We are the only company where you can add synthetic amino acids to any size protein or peptide and produce it at scale,” Turner said.Synthorx also has been meeting with pharmaceutical companies that have developed protein therapeutics that stalled, and could possibly be optimized using Synthorx’s technology.Synthorx will add a chief science officer as well as a chief business officer in coming months, Turner said. Recombinant protein therapeutics already have had a dramatic impact in medicine, and examples abound, such as insulin for diabetes and monoclonal antibodies in cancer immunotherapy. But many protein therapeutics have limitations that stall their advance. For example, certain proteins are only effective if they fold in a particular way.The ability to incorporate synthetic amino acids into proteins also is not new, and many protein therapeutics with synthetic amino acids have been developed, Turner said. “But a lot of them don’t advance because [production] can’t be scaled up commercially. They can’t be made efficiently and at low cost.”

Aids 2016 Day Two of AIDS 2016 AIDS 2016 symposia sessions on the impact of HIV on adolescent girls and young women, and how to reverse it, featured The United States President's Emergency Plan for AIDS Relief (PEPFAR) leader Ambassador Deborah Birx, humanitarian and former South African First Lady Graça Machel, actor and activist Charlize Theron, Global Fund chief Mark Dybul, UNAIDS

Executive Director Michel Sidibé and other towering figures in the fight to achieve female health and empower girls and women to stay safe from HIV. The sessions gave voice to a growing global consensus that prioritizing the needs of girls and young women is essential to saving lives and ending AIDS. Maintaining the spotlight on HIV in times of political upheaval, budget shortfalls, and new epidemics such as Ebola was another Tuesday conference theme, with sessions and media events offering strategies for keeping HIV treatment and prevention moving forward in the face of earthquakes, armed conflicts, the refugee crisis, and a decline in donor funding that advocates called “unprecedented in the history of the AIDS response.” One of the most encouraging elements of AIDS 2016 is the strength of research presented here on progress in HIV prevention. Incoming IAS President Linda-Gail Bekker christened AIDS 2016 as “the dawn of the global PrEP era,” and encouraged delegates to move science into practice for people at risk for HIV, especially key populations. Final results from the Partners Demonstration showed the near elimination of HIV transmission among serodiscordant couples with PrEP and ART, while a number of other studies offered new insights on PrEP uptake, acceptability and adherence. Participants at AIDS 2016 also heard results from HVTN 100, a South African study of a modified version of the RV144 regimen, the only HIV vaccine regimen to show efficacy to date. HVTN 100 adapted the RV144 regimen to make it specific to the southern Africa’s Clade C HIV subtype, changed the adjuvant to elicit a more powerful immune response, and added a booster to prolong protection. The successful study provided the green light for a larger efficacy trial of the improved regimen, which, if successful, could lead to a licensed HIV vaccine in South Africa and the world’s first preventive HIV vaccine. 90-90-90 provides a useful framework and an ambitious set of targets for measuring progress towards achieving HIV diagnosis, referral to treatment and viral suppression – the three pillars of efforts to slow and ultimately stop the epidemic. In the session “Measuring Progress Towards 90-90-90,” presenters contrasted efforts and progress towards the goal across South Africa, Botswana, Namibia, and Zimbabwe. While each setting presents different opportunities and challenges, one striking similarity across the countries appears to be the comparative challenge of engaging men and adolescents in testing. More detailed reports on this and many other sessions from Tuesday, and throughout the conference week, are available on the AIDS 2016 Rapporteur Summary page.

YCBB on BIDU BIDU Baidu Knocked Again Over iQiyi Valuation Bottom line: Baidu will raise the valuation of iQiyi as it sells the unit to outside investors, in a bid to avoid insider dealing accusations, while it will also suffer a revenue hit as it evicts advertisers who operate illegal gambling sites. Baidu can’t seem to catch a break over the past week. First the company was hit by reports of a major rejection in Hollywood, and then an investigative report revealed it was hosting links to illegal gambling sites. Now the company is being rejected again by US investors, who are complaining that Baidu is grossly undervaluing its iQiyi online video service as it prepares to sell the unit to a group led by company chief Robin Li. At the same time, the earlier gambling site scandal is taking a new twist, with the Internet regulator reportedly opening an investigation into the matter. In Baidu’s case, the company is being plagued by several very China specific problems, including lax screening of its advertisers and also a corporate culture that encourages inside dealing benefiting company owners at the expense of minority shareholders.

Baidu first announced plans to sell iQiyi service in April to a group of investors including Baidu founder Robin Li, in a deal that reportedly valued the company at a relatively modest 2.5 billion yuan ($373 million). Now one of Baidu’s major institutional stakeholders, a hedge fund called Acacia, is criticizing the deal as vastly undervaluing iQiyi. It appears some of the earlier valuation figures may have been inaccurate, and now Acacia is saying in a new open letter that the buyout deal actually values iQiyi at $2.8 billion. But Acacia argues that figure is far too low, and that iQiyi should be worth closer to $5.8 billion. Revised Offer Coming?The buyout price does indeed seem a bit low, since iQiyi’s closest rival, Youku Tudou, was valued at about $4.5 billion when it was taken private by e-commerce giant Alibaba last year. It’s a bit unclear what leverage, if any, Acacia will have in the iQiyi deal, since Li probably controls a majority of Baidu shares. But Li can hardly afford another scandal right now, and Acacia may be using that fact to pressure him into raise the sale price for iQiyi. Baidu has already responded that it will form an independent committee to evaluate the original bid (Chinese article), and I do expect that we could see the buyer group revise its proposal to value iQiyi at a higher amount of around $3.5-$4 billion. Next there’s the relatively incremental development that has China’s main Internet regulator opening a formal probe into the gambling scandal that was broken in a media report over the weekend. I previously wrote about this scandal, which centers on online gambling sites that opened advertising accounts to promote legitimate products during the day, only to link to illegal sites during the nighttime hours. The latest reports simply say the Internet regulator has instructed its Beijing branch to probe Baidu on the matter. In the past such probes would have been relatively inconsequential, but that may no longer be the case as China makes more serious efforts to clean up its Internet. Accordingly, we could see Baidu suffer a new wave of lost business as it purges these advertisers that probably account for a small but still significant volume of its advertising revenue, perhaps up to 3-4 percent.

NY Times In vitro fertilization is found to not increase chances of breast cancer article, those having several cycles of treatment are shown to fare better. The study included ~ 21,000 participants in Western Australia who began IVF at 24 or younger , and was published in JAMA Justice Dept prepares lawsuits in move to block ANTM CI and AET HUM, if both transactions fall through, the total amount of transactions would drop to $4.59 trillion and still be the highest since 2007, but not the highest in all times. ANTM will need to pay CI a $1.85 breakup fee and AET will be required to give $1 billion to HUM if the deal breaks

FT ARMH the Softbank bid puts ARMH customers who have substantial investments in it to be concerned article GS quick to blame Brexit for a fall in client activity Hong Kong and its future discussed in feature article in first section in light of Chinese slowdown NVS braced for tough US pricing after presidential poll, NVS has taken a number of restructuring steps in the past six months to shift from a loosely affiliated set of division where there is heavy duplication in back office functions to a fully integrated company. He suggested

the EU vote on Brexit would have little impact on NVS, Jimenez confirmed that they were looking for an opportunity to sell their $ 14 billion stake in RHHBY NFLX skeptical commentary in FT LEX NTDOY skeptical commentary in FT LEX Tata Thyssen Krupp potential European steelmaking JV article, this could be the biggest change in the steel sector for a decade

Bioworld headlines A collaborative study by U.S. and Chinese researchers has identified an immune system component responsible for the homeostatic control of innate immune responses to nosocomial invasive candidiasis, which represents a potential target that may lead to the development of treatments for the fungal infection “When people learn that tuberculosis is airborne, that it kills millions of people, that drug resistance is spreading, watch their reaction – they do not think that TB is boring anymore,” Jose Luis Castro, executive director of the International Union Against Tuberculosis and Lung Disease, told the audience at the 2016 international AIDS conference. Castro was referring to the fact that despite overtaking HIV in 2015 as the world’s leading infectious disease killer, TB does not have nearly the attention or resources devoted to it that HIV does. While HIV, TB and malaria are officially considered the Big Three infectious disease threats by the World Health Organization, in practice, HIV tends to hog the spotlight. Ireland is claiming a little victory on foot of a new drug pricing agreement with the pharmaceutical industry, which will help to keep a lid on rising drug prices between now and 2020. Officials did not make any claims that Ireland’s drugs bill is going to get any lower, given the pipeline of expensive new treatments in the offing and the country’s expanding and aging population. But it might get a little more bang for the bucks that it will spend – which currently runs to about €1.7 billion annually. The agreement with the Irish Pharmaceutical Healthcare Association (IPHA) runs from Aug. 1, 2016 through July 31 2020, and is slated to deliver annual savings of about €150 million (US$165 million) over its four-year lifetime.

AEI on The Republican Platform The Republican platform seems to have taken its cue from Speaker Paul Ryan’s A Better Way, at least when it comes to health policy. Not surprisingly, health care did not get top billing in the 66 page document. The economy, jobs, and taxes led off, with the Affordable Care Act (ACA), Medicare, and Medicaid relegated to later chapters. Although there is not much text, those words are important. Significantly, the platform takes up Medicare and Medicaid in the chapter on government reform. The document points out that Medicare’s long-term debt is in the trillions, and does not shrink from recommending actions that could set the program on a fiscally sound path. That requires change that will not be welcomed by everyone, so the platform pushes off that change for a decade in the hope of not alienating the senior vote. Nonetheless, the Republican Party has now officially endorsed Ryan’s premium support plan that can promote competition and more efficient health care. Medicaid would be funded through a block grant to the states, who would have more control over how their health programs for the poor are run. What the platform committee left out is a better idea for Medicaid advanced by Ryan’s plan: a per capita allotment, which would fine-tune the federal grant to states to better reflect the needs of their Medicaid populations

We have to wait until p. 36 before we see what the Republican platform has to say about the ACA. No surprise here: Obamacare’s “dead hand of the past” that weighs down American medicine would be repealed, along with the taxes that were imposed to help fund the new insurance subsidies. The document reminds us that a Republican president would have the authority to “halt [ACA’s] advance” on his first day in office. That clearly signals an understanding that rolling back subsidies to millions of people who enrolled on the insurance exchanges is neither practical nor politically smart. Insurance regulation would return to the states, although what is left in federal control remains uncertain. The usual platitudes about competition, price transparency, and electronic medical records are repeated. More interesting is the guarantee that individuals with pre-existing conditions who maintain continuous insurance coverage would not be charged higher premiums or lose benefits. This is a positive incentive that replaces the ACA’s individual mandate, with its threat of fines levied on those who fail to buy insurance. The platform committee also recommends repealing the McCarran-Ferguson Act, which protects insurers from antitrust litigation. That one-ups the Ryan plan, which proposes to study the issue. Regrettably, neither plan addresses the larger problem of consolidation on both sides of the health care market. Provider consolidation is at least as significant a factor in discouraging effective competition that would benefit consumers and taxpayers alike. It seems clear that insurers cannot expect support from either political party in their ongoing merger efforts. The Republican Party has stated where it stands on health care and other policy issues. It remains to be seen where their candidate lands on those same issues.

Health Populi Blog on Retail clinics growth Retail clinics are a growing source of primary care for more U.S. health consumers, discussed Accenture retail clinics to 2017in a review of retail clinics published by Drug Store News in July 2016.There will be more than 2,800 retail clinics by 2018, according to Accenture’s tea leaves. Two key drivers will bolster retail clinics’ relevance and quality in local health delivery systems: Clinics are growing in both number and in the roster of services offered, going beyond urgent care toward more population health and chronic disease management services. The Robert Wood Johnson Foundation noted that, “Some delivery systems seeking to improve primary care access and manage total cost of care are using retail clinics to reduce unnecessary emergency department (ED) visits,” given that retail clinics’ costs are lower than EDs and some hospital-based ambulatory departments. Drug Store News pointed out several clinic innovations in this special issue: CVS Health’s MinuteClinics number over 1,100 clinics (including 79 in Target stores). They are growing clinical affiliations with medical schools and teaching hospitals such as the Cleveland Clinic, University of Chicago Medical Center, and the University of Michigan Health System, among others. CVS Health’s clinics use an electronic health records system that can share information with health providers and collaborate between the retail health setting and health providers. WBA Walgreens operates over Healthcare Clinics and 50 other clinics in stores run by other providers. The company is moving toward more coordinated care models beyond urgent care services, and has invested in an Epic EHR to build that communications/IT infrastructure for a vision of seamless care delivered in the community.

The Little Clinic operates in KR Kroger grocery stores, which is a leader in grocery chains delivering healthcare services. The company makes the connection between health and healthy food, and engages dietitians in their care model in the Little Clinics. THINK: weight management, diabetes care, food allergies, and other consumer-facing health issues that can be self-managed. As grocers engage nutritionists and dietitians, retail clinics conduct full physical exams (for $40, in the case of Walmart’s new clinic model), and pharmacists take on the role of medication therapy management, consumers can readily access primary care in their close-by community. That convenience, accessibility and “close-by” neighborhood feeling can help bolster medication adherence, continuity of care, and more effective self-care if health care providers (hospitals, clinicians) — especially those taking on more value-based payment in all forms — are willing to collaborate. The new entrants are willing, ready, and able to do so. And as patients, now health care consumers, are learning to manage high-deductible health plans and health savings accounts, a $40 visit to a PCP is a high-value healthcare proposition.

July 19, 2016

My Informal takeover notes with attributions *health in green, tech in purple, energy/basic in blue, retail in maroon, financials in orange, miscellaneous in black

Jul 19 2016 FOMX while the company may or may not be attractive as a takeover target in the near-term, successful FMX101 phase 3 trial results could provide further validation for its foam-based platform and could make some large cap pharma companies more interested. PFE acquisition of ANAC is a good enough reason to think that the dermatology space is very attractive, especially if one can get an advantage over competitors through differentiation via improved efficacy and safety in a quite large addressable market, article on FOMX in Seeking Alpha

Jul 19 2016 PFE in regards to FOMX, while the FOMX may or may not be attractive as a takeover target in the near-term, successful FMX101 phase 3 trial results could provide further validation for its foam-based platform and could make some large cap pharma companies more interested. PFE acquisition of ANAC is a good enough reason to think that the dermatology space is very attractive, especially if one can get an advantage over competitors through differentiation via improved efficacy and safety in a quite large addressable market, article in Seeking Alpha

Jul 19 2016 AZN has rebuffed takeover offers in the past, but will prior suitors come back to the table? Are there others lurking on the sidelines? Let's talk, article in Seeking Alpha Jul 18 2016 Givaudan has a large pipeline of potential deals, Chief Executive Gilles Andrier said in an interview with Reuters. CEO says company looking at deals in both flavours and fragrances divisions, Givaudan wants to increase sales with local and regional companies

CNBC UTHR The brilliant Martine Rothblatt was interviewed this morning and discussed UTHR’s robust pharmaceutical pipeline, 4 main products a their partnership with J. Craig Venter, UTHR’s work in regenerative medicine and transplantable organs. J. Craig Venter wa also interviewed on the latest developments for synthetic biology and thoughts for the future

Seeking Alpha from Jul 18 2016 on PACB as takeout bait PACB PacBio has sold off from its buyout rumor-spiked highs, but the initial interest in the new Sequel system seems solid. RHHBY second half launch of the clinical version of Sequel should begin to clarify the potential of the diagnostics opportunity and Roche's real buyout interest.Attaining $1 billion in revenue ten years down the road would support a fair value of $11.50 today, even with ongoing capital raises to offset years of negative FCF. PACB has developed a sequencing technology that is very good at doing a limited (but important and significant) number of things within the overall sequencing opportunity. PacBio will never be another Illumina or Thermo Fisher/Ion Torrent but it can grow to over $1 billion in revenue over time on the strength of opportunities in areas like microbial/viral genetics, plant/animal genetics, and human genetics and diagnostics (particularly oncology). With that, I still believe a low double-digit fair value is reasonable. Given the pullback in the shares since my last write-up, this looks like it may be a good time for some due diligence on the name. Investors got understandably excited in the fall of 2015 when PacBio rolled out its new Sequel system. With a much smaller, much more profitable "box" and newly-designed consumable (the SMRT cell) with nearly seven times more waveguides, this new system can offer affordable whole genomes in about a day with long read lengths that Illumina and Thermo can't match. The brighter side to this is that PacBio management has anticipated and guided around a lot of this. An update to the chemistry and software has already been made, and management has been pretty clear since at least January of this year that the launch would proceed slowly until the second half of the year. The company is transitioning production of the SMRT cells from its prototype vendor to its manufacturing vendor, and once that process is complete there should be much less supply constraint. PacBio's partner RHHBY is expected to launch the clinical version of the Sequel later this year. It sounds as though the initial menu of panels will be focused around virology, with Roche targeting HIV resistance tropism, HCV resistance, and HBV resistance. While it will take time to fully leverage the opportunity in human diagnostics (investors can look Will The Suitors Come Knocking? There were rumors in 2015 and into early 2016 that PacBio was drawing buyout interest, with rumored suitors including RHHBY and GSK. How much of this was ever real, how much of it was "tire-kicking," and how much was sell-side analysts engaging in rumor-mongering to spur trading volume is unknown, but it's not surprising to me that PacBio would get some interest. RHHBY would seem to me to be the most logical motivated buyer. The companies have a partnership for the Sequel that allows Roche to sell it into the clinical market. A less-than-perfect arrangement for Roche insofar as it excludes the large research market and requires the company to shoulder the burden of marketing while splitting revenue.It wouldn't surprise me if Roche did approach PacBio but that the companies were too far apart on pricing - PacBio is going to want to get paid for the potential of the Sequel in the clinical setting (and arguably has a fiduciary duty to make that happen), while Roche isn't going to want to pay full value for a system with unknown appeal in that clinical space. Should sales ramp up as expected later this year, I would think the companies could come to the table and strike a bargain. A strong launch will likely make it easier for Roche to pay up and explain the premium to its shareholders. That said, PacBio should be careful not to overplay its own hand.

Roche continues to work on the technology it acquired when it bought Genia, with the company announcing proof-of-concept back in April for this sequencing technology that electronically detects and differentiates polymer-tagged DNA bases (theoretically allowing for fast, long reads). PacBio is also facing several more years of negative free cash flow and dilution for shareholders, so a buyout is not a ridiculous idea for either party.I'm positive on PacBio in large part because I believe the company's technology can address real-world sequencing challenges that constitute a meaningful market.

New health & related co specific events to add DXCM conference call to discuss the Jul 21 2016 FDA meeting on CGM device meeting starting at 8:30 ET Jul 22 2016 JNJ Glenmark must answer JNJ new suit over its cancer drug Zytiga by Jul 24 2016 (source BBERG) Spartan Bioscience will be launching the Cube and an initial assay menu at AACC Jul 31 2016 CELG postponed case scheduling in the suit over Abraxane copies to Jul 29 2016 (source BBERG) AMNEAL a decision on whether SHPG can amend its complaint against Amneal over Lialda copies is postponed until Sep 1 2016 (source BBERG) SHPG a decision on whether SHPG can amend its complaint against Amneal over Lialda copies is postponed until Sep 1 2016 (source BBERG) INCY updated data from the Phase 1 portion of the ECHO-202/KEYNOTE-037 trial has been accepted for a poster discussion at the ESMO Oct 10 2016 PRQR Top-line data from the 16 patients in Study PQ-010-002 is expected to be presented during the NACFC Oct 27-29 2016 ARMH ARM TECHCON a record 4,500 attendees—including hardware design engineers, software developers, system architects, and many more—will unite at the leading event for technology, training, and networking in ARM-based embedded systems.– Santa Clara Oct 25-27 2016

Other events of note with new details Gigaom Change 2016 Leaders Summit A global, unified collection of strategists, data scientists, writers, filmmakers, and social media provocateurs that speak 37 languages in 16 offices, spanning the globe from Seattle to Shanghai and Boston to Bangalore; We're excited to have this awesome group as a partner in bringing you Gigaom Chang 2016.3D+ Printing Is Set To Change The Way The World Looks, And Functions.How Can We Start Loving The Robots?, Artificial Intelligence , Cybesecurity, Virtual Reality nanotechnology, in Austin Texas Sep 21-23 2016 . BioData World USA’s flagship event for decision makers and thought leaders working in omics, diagnostics and R&D from across USA and beyond. Close to 300 participants attended the European edition in 2015! BioData World Congress USA will examine the science and the business strategy behind the utilisation of HPC, NGS, cloud computing and all other related technology in the pursuit of personalised medicine: Harvard, Boston University,T-Gen,RHHBY, GSK, CELG,AZN, TAKEDA, REGN ,AAPL, Fred Hutchinson Cancer Research Centre, BeatNB Foundation, Spectrum Health System, Geisinger Health System, National Comprehensive Cancer Network,Cold Spring Harbour

Laboratory Sheikh Khalifa Bin Zayed Al Nahyan, Institute for Personalized Cancer Therapy (IPCT),N.I.S.T. (National Institute For Standards and Technology) NIH, NMTRC, Brigham and Women's Hospital, Global Alliance for Genomics and Health (GA4GH), Boston Children's Hospita, lAutism Speaks, Ulsan National Institute of Science and Technology John Hopkins Medical Centre Precision FDA Community -Boston Sep 14-15 2016 Ragan’s “Employee Communications, PR & Social Media Summit,” Redmond, Washington Sep 28–30 2016 Commercial Excellence for Chemicals 2016 Sep 22 2016 COPD: Modeling Future Needs to Adapt Novel Therapeutics and Management strategies Oct 19 2016 ARM TECHCON a record 4,500 attendees—including hardware design engineers, software developers, system architects, and many more—will unite at the leading event for technology, training, and networking in ARM-based embedded systems.– Santa Clara Oct 25-27 2016 Second Annual Conference and Expo on Biomaterials- Oct 19 2016 SPIE Medical Imaging 2017- Orlando Feb 11-16 2017 9th German Cardio Diagnostics Day and 10th Non Invasive Cardiovascular Imaging Symposium- Leipzig Feb 23-25 2017 KIMES 2017- South Korea Mar 16-19 2017 2nd Annual Conference and Expo on Biomaterials Mar 27 2017 Medical Fair India New Delhi Apr 6-8 2017 Intl Symposium on Biomedical Imaging IBSI –Australia, Apr 18-21 2017 Echocardiography in the Nation's Capital Apr 21 2017 Echo 2017 European Conference on Interventional Oncology- Bilbao Spain Apr 23-26 2017 Radiology in Venice – Venice Italy Apr 23-29 2017 Society for Pediatric Radiology- British Columbia Canada May 16-20 2017 The XXIII World Congress of Neurology Sep 15 2017

Belkin The ratio of the VIX to realized S&P 500 index vol has reached the second lowest levels. The market is setting up for big percentage moves, probably to the downside, puts are ridiculously cheap

John Hussman letter

http://www.hussmanfunds.com From a long-term and full-cycle perspective, the most reliable valuation measures we follow - those with the strongest correlation with actual subsequent stock market returns across history - are consistent with roughly zero S&P 500 nominal total returns on a 10-12 year horizon, and the likelihood of an interim market loss of about 40-55% over the completion of the current cycle. As I noted last week, however, our near-term outlook is rather neutral, largely because enough trend-following components have improved (though our broadest measures of market internals have not) to keep us from pounding tables about immediate losses. Even as we allow for further near-term speculation, I remain convinced that the S&P 500 is likely to be lower a decade from now than it is today.

The only wrinkle in an otherwise spectacularly hostile investment environment is that speculators appear to be so possessed by collapsing global interest rates that the immediacy of a market loss may be deferred until this fresh round of yield-seeking exhausts itself. As one observer told Bloomberg last week, “they’re out there scrounging through the dumpster looking for yield.” Put simply, stocks will collapse over the completion of the present market cycle, even given a zero-interest rate environment, because the combination of frantic yield-seeking speculation and weak prospects for economic growth has already established the most punitive and unattractive full-cycle return/risk tradeoff for stocks since 1929.

EE Times on Softbank ARMH deal SoftBank is neither a competitor nor a customer to ARM. So it remains unclear why on earth Son wants ARM — other than to expand his investment portfolio. SoftBank is Japanese, but it’s a company that defies the stuffy stereotype. It doesn’t subscribe to such Japanese traditions as snail’d-pace decision-making, bureaucratic quagmires, endless “internal” discussions, insular thinking and the ultimate paralysis of indecision. , Softbank today is a telecommunications and Internet giant. Its businesses encompass broadband, fixed-line, e-commerce, Internet, technology services, finance and media.To outsiders, though, the most vexing question about SoftBank’s deal with ARM is SoftBank itself. Irrational exuberance for IoT and AI?In announcing the deal with ARM, Son made a pitch for the Internet of Things (IoT) and artificial intelligence (AI), touting them as SoftBank’s next growth engine Why does plunking down $32 billion for ARM really make sense for SoftBank? Some industry analysts believe that the deal tells a story more about Son himself, rather than ARM’s market prospects or any realistic assessment of the Internet of Things in the future.Mike Demler, a senior analyst at The Linley Group, told EE Times, “The deal looks more driven by Chairman/CEO Son’s personal desire to own a market leader than a sound financial analysis.”Quoting Son, who remarked at the press conference that up ‘til now Softbank hasn’t owned a company that was number one in its segment, Demler said, “ARM has good growth potential, so it makes a nice trophy for his M&A portfolio. But the $32 billion valuation makes absolutely no sense.” Softbank bets that paid off include a $20 million investment in e-commerce company Alibaba Group Holding in 2000, now worth $65 billion, and the $15 billion acquisition of Vodafone’s lossmaking Japanese arm in 2006. That move positioned SoftBank as the number three carrier in the market.SoftBank has accumulated $18 billion (2 trillion yen) in cash in recent months by unwinding its stakes in Alibaba, Japanese smartphone game developer GungHo Online Entertainment, and Finnish mobile game provider Supercell.

Undoubtedly, Son’s audacity and the available cash on hand made this deal with ARM possible. But if all goes well, getting a service provider to fund the hardware business on the IoT market is probably not a bad move. One could argue that SoftBank, as a mobile service provider, has a role to play in advancing the IoT market.The same could be said about AI. Although this could also be viewed as an example of Son’s irrational exuberance, Son’s passion for robots is well known.SoftBank, two years ago, turned to Aldebaran Robotics, a Paris-based startup, to create a robot billed as the first robot that can sense people’s feelings.Named Pepper, the humanoid machine promoted by SoftBank is said to come with “emotions.” Designed to sidle up to humans

and to engage them in conversation, Pepper is envisioned in a variety of roles, from nurse to babysitter to portable entertainment provider. In an interview with Fortune, SoftBank’s former president Nikesh Arora, who recently resigned, described Son as “a person with amazing enthusiasm.”Arora called Son “an extremely positive person. Once he gets optimistic, I think sometimes he gets carried away. Part of doing things together is tempering some of that enthusiasm sometimes.”Arora explained Son’s passion for robots. He noted that Son “has an idea per minute. [Recently] he presented his views of the singularity to the SoftBank board. He’s building a robot with a heart. It has Watson in it—that’s supposed to be the rational part of brain, and he’s building the emotional part of it. That’s crazy enough for me. But he’s executing on it. He’s selling 1000 of them every month.” On its web site, SoftBank talks about its growth as a corporate group “for the next 30 years” It says, SoftBank “strives to develop over the long-term by forming partnerships with the most superior companies at the time in the information industry, without adhering to particular technologies or business models.”Also, the company “aims to expand its Group companies which share the same vision to 5,000 in 30 years through building strategic synergy group which can make self-evolution and self-multiplication.” Jim McGregor, principal analyst at Tirias Research, is less worried. The deal, he noted, has little impact on ARM licensees. As he explained, “Softbank, because of its structure and not being in the semiconductor industry, is for the most part a neutral 3rd party, just like ARM.” He said, “If anything, hopefully, the investment will bring innovation and lower prices to markets like IoT, networking, and communications, just like ARM has done to mobile and consumer electronics.” He added, “I have been asked if the would mean higher fees for licensees, and I do not believe so. I can't see SoftBank messing with a successful business model and decreasing prices are an economic foundation of the semiconductor industry.” The Linley Group’s Demler is more worried.Asked about changes SoftBank might bring to ARM, Demler said, “The first, unfortunately, is that I expect less openness from ARM.”In his opinion, as a public company, ARM has communicated well with the analyst community and the semiconductor ecosystem. “I hope I’m wrong about that, but we’ll see.” He added, “The second change comes from ownership that looks at the company purely as another holding in its diverse portfolio. Financial motives are likely to trump strategy in guiding the company forward, and starting with a $7 billion loan to pull it off can’t be overlooked.” Asked about the potential upside for ARM licensees, Demler bluntly said there is none. “There’s little synergy with SoftBank’s other businesses. The acquisition is purely a financial move,” he noted.“Son said he was going to double ARM’s head count, but I don’t believe lack of head count has been a factor inhibiting ARM’s growth, or affecting support for their customers. The downside would be if key ARM personnel left because of the acquisition, which is always a consideration,” Demler added.

NY Times Science Section The work in Zika and Ebola being done by of David H O Connor from Univ of Wisconsin head of global infectious disease dept Some people metabolize caffeine faster than others

Tech Insider on AAPL

Evan Blass, one of the most prominent gadget leakers in the world, refuted rumors that said Apple would release a third new iPhone model this year in addition to the iPhone 7 and iPhone 7 Plus, called the "iPhone Pro." On Tuesday, Blass claimed on Twitter that Apple is releasing only two iPhone models, which Apple has codenamed "Sonora" and "Dos Palos." Blass' tweet is below: The logic is that if there are only two code names, there are only two iPhones. Unfortunately, the code names don't reveal anything about Apple's upcoming iPhones, as they only describe names of towns in California, a very Apple thing to do considering the company often names its products after California themes. Monday's leaked photos, one of which is at the top of this story, countered the majority of earlier rumors by showing off an iPhone 7 "Pro" model that comes with a dual-camera and a Smart Connector, which would presumably be sold next to an iPhone 7 Plus that has the same single-lens camera as the 4.7-inch iPhone 7. However, if Blass is right, it might be Apple's iPhone 7 Plus that comes with a dual-lens camera, while the regular iPhone 7 could still have its single-lens camera, and there would be no "Pro" model. Blass' tweet also helps confirm our suspicions that the photo leaked on Monday was a fake, as the devices in the photo showed the "S" symbol on the back of the phone (the most recent iPhone, the iPhone 6s, was an "S" model). Aside from these recent rumors, everything we've seen suggests the iPhone 7 will look very similar to the iPhone 6 generation, and some have even claimed that it'll be part of the iPhone 6 generation rather than a brand new iPhone model. That's an interesting rumor, as it would mean that Apple is breaking its usual "tick-tock" release cycle where a new iPhone generation is the tick, and the "S" model is the tock. If the above photo turns out to be true, Apple's next iPhone would be another tock in the cycle. What else can you expect from the iPhone 7? Expect redesigned antenna lines that wrap around the top and bottom edges of the iPhone instead of traversing across the back of the iPhone's back, like they do in the iPhone 6 generation. And, of course, it looks like the iPhone 7 may be the first iPhone to ditch the traditional 3.5mm headphone jack. However, we won't know if any of these rumors are true until we see the actual iPhones in September during Apple's fall iPhone event .

Health news 4D Pharma the findings of its first Blautix for the treatment of IBS clinical trial are encouraging and provide a solid basis for progressing Blautix into larger clinical. The results of this clinical study appear to confirm the translational power of the humanised disease models. In conclusion, the findings of this first clinical trial are encouraging and provide a solid basis for progressing Blautix into larger clinical studies and further evaluation as a potential treatment for IBS. 23andMe recently added a 16-person team to develop new antibody therapeutics, “prioritizing targets for diseases of significant unmet needs” involving cardiovascular ailments, cancer, and asthma, Erik Karrer, who heads the effort, told STAT. Nearly 1 million customers have permitted their genetic profiles to be used for research, and Karrer's team is mining that data in search of links to diseases. Seven antibody programs are in early development. The company plans to move strong candidates through phase 2 clinical trials, then partner with bigger companies for large-scale testing. And it's preparing for growth: 23andMe intends to expand its drug-discovery team to 25 this year and 50 next year, Karrer said.

ADHD Alcobra granted European Orphan Drug designation for Metadoxine in fragile X syndrome Alcobra announces that the European Commission (EC) has granted Orphan Drug designation to Metadoxine for the treatment of Fragile X Syndrome within the European Union. ADMS with AGN news that the FDA approves expanded label for NAMZARIC With the new indication, patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg), can now start combination therapy directly with NAMZARIC. With the new, expanded indication, NAMZARIC will be available in four dosage strengths which allows patients currently taking Aricept 10mg to start on NAMZARIC the very next day. The two new NAMZARIC dosage strengths will be available in pharmacies in September AET U.S. antitrust officials are poised to file lawsuits to block Cigna/Anthem, Humana/Aetna, according to a person familiar with the matter. Final decision could come as soon as this week AGEN CFO C. Evan Ballantyne to resign effective Jul 29 2016. Christine M. Klaskin, Agenus’ Vice President, Finance and principal accounting officer, will retain her roles and assume the role of principal financial officer. Klaskin has served in various finance roles at Agenus since 1996. AGN ADMS news that the FDA approves expanded label for NAMZARIC With the new indication, patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg), can now start combination therapy directly with NAMZARIC. With the new, expanded indication, NAMZARIC will be available in four dosage strengths which allows patients currently taking Aricept 10mg to start on NAMZARIC the very next day. The two new NAMZARIC dosage strengths will be available in pharmacies in September AKRX RBC comments on Akorn, CRL for Sagent's generic Nembutal The firm notes Sagent (SGNT) has indicated that it has received a Complete Response Letter for generic Nembutal. The delay is expected to push out generic entry by roughly a year. RBC believes a one year delay could add ~$0.05-$0.07 to both 2016 and 2017 EPS. Shares of AKRX remain outperform rated with a $37 target. Analyst is Randall Stanicky. SGNT AMGN NVS Sandoz says it received CRL for its Neulasta biosimilar, NVS in today's earnings release, NVSs disclosed that its Sandoz unit received a Complete Response Letter (CRL) from the FDA for its biosimilar pegfilgrastim candidate (Neulasta, AMGN). The company says it is working with the FDA to address remaining questions with the application for LA-EP2006. ANTM U.S. antitrust officials are poised to file lawsuits to block Cigna/Anthem, Humana/Aetna, according to a person familiar with the matter. Final decision could come as soon as this week Antibe Therapeutics recruited the final patient to its phase II trial testing ATB-346, a candidate designed to provide non-addictive treatment of chronic pain and inflammation, in patients with osteoarthritis. Final results are expected by mid-August ANGLE initiates European ovarian cancer study and recruits first patient . The ovarian cancer study (known as ANG-001) is a 200 patient study, recruiting women diagnosed with a pelvic mass by imaging studies who are scheduled to receive surgery for the removal of their masses. Blood from consenting patients will be analysed using the Parsortix system and RNA from the cell harvests will be evaluated to detect the presence or absence of ovarian CTCs (circulating tumour cells). The aim is to discriminate successfully between women with benign and malignant masses as confirmed by the histopathological examination of the tissue post-surgery. The aim is to complete the study by 2016 calendar year end.

ARNA with EISAI, ARNA issues press release on previously announced FDA approval of Belviq XR The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss. BELVIQ XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10M milestone payment from EISAI. AZN BMY receives approval in EU for Qtern saxagliptin/dapagliflozin for treatment of type 2 diabetes tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, adopted a positive opinion recommending the granting of a marketing authorisation for AstraZeneca's Qtern AZN to collaborate with Canada's national drug development and commercialization centre The Centre for Drug Research and Development ('CDRD') announced a strategic collaboration with AstraZeneca to identify novel drug targets across a range of diseases where there is an unmet medical need in order to develop new or improved therapies for the benefit of patients. AstraZeneca will make available 250,000 compounds from its chemical compound library to CDRD to validate and develop promising new drug BAYER Corvex is building small stakes in MON and BAYER BAYER MON views BAYERS revised proposal as financially inadequate; remains open to talks Monsanto announced that its board unanimously views Bayer AG’s revised proposal as financially inadequate and insufficient to ensure deal certainty. Monsanto remains open to continued and constructive conversations with Bayer and other parties to assess whether a transaction that the board believes is in the best interest of Monsanto shareowners can be realized. There is no assurance that any transaction will be entered into or consummated, or on what terms. CELG news that closely-held Jounce Therapeutics to get $225m upfront, $36m equity investment from Celgene in immuno-oncology license pact. Jounce may also get regulatory, development, sales milestone worth up to $2.3b, tiered royalties on ex-US sales Accord includes options on Jounce lead product candidate JTX-2011 and up to 4 early-stage immunotherapies from programs targeting B cells, T cells and tumor-associated macrophages Jounce, Celgene would split U.S. profits 60%/40% respectively for JTX-2011, next product 25%/75% and 50%/50% for up to three more products CERU receives FDA Fast Track designation for CRLX101 for the treatment of platinum-resistant ovarian cancer The FDA granted Fast Track designation for Cerulean’s lead nanoparticle-drug conjugate, CRLX101, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer. Chugai Pharmaceutical news that Galderma Pharma has picked up the rights to a midphase atopic dermatitis and pruritus drug from Roche’s Chugai Pharmaceutical. The deal gives Galderma an exclusive license to develop and market the drug, the first biologic in its portfolio, in all countries except Japan and Taiwan.Galderma is committing to upfront, milestone and royalty payments of an undisclosed amount to gain the rights to the drug, the anti-IL-31 receptor A humanized monoclonal antibody nemolizumab. The addition of nemolizumab to Galderma’s pipeline marks the first time the dermatology specialist has forayed into biologics, a class of products it has eschewed in the past to keep its focus on topical therapies. Chugai will continue to handle manufacturing of the drug. Once the deal with Galderma is complete, Chugai will retain control of the drug in Japan and Taiwan, leaving its new Swiss partner to take up development in the rest of the world.

By broadening its dermatology pipeline into biologics, Galderma is following in the footsteps of Leo Pharma, a fellow European drugmaker that bought its way into injectables earlier this month with a $1 billion (€900 million) deal for AstraZeneca’s (AZN) tralokinumab. The back-to-back deals position Leo and Galderma to fight for a share of the atopic dermatitis market, a space in which deal making and competition have intensified over the past year. Both Galderma’s nemolizumab and Leo’s anti-IL-13 antibody tralokinumab are injectable treatments for moderate-to-severe forms of atopic dermatitis. The competition includes dupilumab, an antibody being developed by Regeneron (REGN) and Sanofi (SNY). With dupilumab having already delivered Phase III data and being pencilled in to come to market next year, the chasing pack know how high the bar has been set. Dupilumab, which is designed to inhibit both IL-4 and IL-13, cleared lesions from the skin of more than one-third of people who received it in Phase III trials. The placebo failed to get above 10%. Chugai’s Phase II trial looked at a different endpoint, itchiness. Nemolizumab was linked to a 60% decrease. The placebo arm trended downward 20%. Chugai is currently running a Phase II trial of the drug as a treatment for itching in hemodialysis patients in Japan. Once the deal with Galderma is complete, Chugai will retain control of the drug in Japan and Taiwan, leaving its new Swiss partner to take up development in the rest of the world. CI U.S. antitrust officials are poised to file lawsuits to block Cigna/Anthem, Humana/Aetna, according to a person familiar with the matter. Final decision could come as soon as this week CYDY submits protocol for Phase 2B trial for treatment naïve HIV patients It has submitted a new protocol to the FDA for treatment naïve patients under its current open IND (Investigative New Drug application). CYTX announced the publication of the results from an investigator-initiated Phase I trial using Cytori Cell Therapy in patients with insufficient maxillary bone prior to dental implantation The paper is titled: “Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics” published in the journal Stem Cells Translational Medicine. The publication reported approximately 42% greater bone formation in maxillary sinus floor elevation (MSFE) procedures treated with cells in combination with scaffolds versus those that received scaffold alone. The study enrolled 10 patients requiring dental implants but who had insufficient bone into which the implant could be inserted. The maxillary bone deficiency was treated with two different commonly-used, off-the-shelf bone calcium phosphate scaffolds that were used either alone or pre-loaded with Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori’s Celution System. In six patients, the patient served as their own control as one side of the mouth was treated with scaffold alone and the other side was treated with ADRC-supplemented grafts. Six months after treatment all patients underwent dental implant placement at which time a biopsy of the regenerated bone at the graft site was performed. CYNA open-label dose-titration data from ongoing Phase 3 study of APL-130277 showed mean change in Parkinson’s disease rating scale of 22 points after 30 minutes. 83% of patients turned from off to fully on; 78% of patients turned fully on within 30 minutes APL-130277 was well tolerated; CYNA says findings increase confidence that sample size is more than sufficient to show meaningful changes in primary and key secondary endpoints of study, CYNA sees top-line study results in late 3Q or early 4Q 2016

DELL EMC shareholders back $ 62 billion takeover offer with DELL, VMW will own < than 50 % of the company and the cash portion of the offer will leave DELL with nearly $ 50 billion in debt prompting them to sell non core businesses DiaMedica a US-Canada biopharma, raised $4 million from China's Hermed Capital Healthcare Fund. Hermed was formed by Shanghai Fosun Pharma and SK Group, a South Korean conglomerate. DiaMedica is developing DM199, a purified form of recombinant tissue kallikrein (rhKLK-1) protein, which activates several metabolic pathways and, through vasodilation, improves blood flow. DiaMedical's DM199 is a proposed treatment for ischemic stroke and kidney disease. DRIO LabStyle reports 100%-plus monthly growth in U.S. users since launch LabStyle Innovations announces that since the U.S. soft launch in March, the company has seen rapid market penetration, including better than 100% growth per month in users during Q2. Initial results: More than 4,550 Dario All-in-one Smart Glucose Meter Devices were purchased by U.S. customers by 30-Jun-16 At June end, the company had more than 4,900 U.S. users registered on its servers This traction initiated by a soft launch has ramped during Q2, as 3,000 of the devices were purchased in June alone, representing 200% growth over the soft launch period initiated at H2 of March, 2016 in the U.S. DXCM FDA releases briefing documents ahead of jul 21 2016 Adcom meeting for Dexcom's G5 Mobile CGM System. The documents provide context for the discussion around Dexcom’s premarket approval application supplement (PMA-S) for a proposed change in the intended use of Dexcom’s G5 Mobile CGM System so that a patient can use the device to make diabetes treatment decisions based on the interstitial fluid glucose concentration reported by the CGM. Dexcom management will hold a conference call to discuss the meeting starting at 8:30 ET on Friday, Jul 22 2016 EGLT announced the issuance of two patents by the U.S. Patent and Trademark Office for Egalet's proprietary Guardian Technology. U.S. patent number 9,358,295 covers through 2031 immediate-release formulations intended to be resistant to abuse by intake of alcohol, and U.S. patent number 9,375,428 covers through 2024 extended-release formulations of opioids. . EISAI news that ARNA issues press release on previously announced FDA approval of Belviq XR The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss. BELVIQ XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10M milestone payment from EISAI. EMC shareholders back $ 62 billion takeover offer with DELL, VMW will own < than 50 % of the company and the cash portion of the offer will leave DELL with nearly $ 50 billion in debt prompting them to sell non core businesses FOMX positive in Seeking Alpha, reviews these potentially value-creating catalysts which are scheduled for the next 6-18 months: FMX103 phase 2 study results in 2H 2016. FMX102 photo-safety study in 2H 2016. FMX101 phase 3 study results (blinded phase) in 1H 2017 - this is the most important catalyst for Foamix and could move the share price by 50% or more. FMX103 phase 3 initiation in 2H 2017. FMX101 phase 3 study completion in 2H 2017 followed by an NDA filing by year-end 2017 and an eventual approval and launch in 2H 2018. Foamix could be a substantially de-risked stock by mid-2017, depending on FMX101's phase 3 trial results in 1H 2017.

Fulcrum Therapeutics Third Rock Ventures announced it’s committing $55 million to launch Fulcrum Therapeutics, a Cambridge MASS co that is developing pills to treat the underlying cause of rare genetic diseases such as Fragile X syndrome and a form of muscular dystrophy. Robert Gould, the former CEO of EPZM will lead the company, which was founded by Michael Green of University of Massachusetts Medical School; Danny Reinberg of New York University School of Medicine; Rudolf Jaenisch of the Whitehead Institute; Jeannie Lee and Brad Bernstein, both of Massachusetts General Hospital. The company’s drugs will all be small-molecule pills, and it will likely be a couple years before the drugs get to the point of starting clinical trials, Gould said. One of the first two drugs in development is intended to treat Fragile X syndrome, a mutation of the X chromosome that makes it look like a piece is about to break off. The disease is the leading inherited cause of mental disability and autism. The other drug in development would treat facioscapulohumeral muscular dystrophy, turning on a gene that is repressed in such patients. Article is discussed in BBJ Galderma Pharma has picked up the rights to a midphase atopic dermatitis and pruritus drug from RHHBY Chugai Pharmaceutical. The deal gives Galderma an exclusive license to develop and market the drug, the first biologic in its portfolio, in all countries except Japan and Taiwan.Galderma is committing to upfront, milestone and royalty payments of an undisclosed amount to gain the rights to the drug, the anti-IL-31 receptor A humanized monoclonal antibody nemolizumab. The addition of nemolizumab to Galderma’s pipeline marks the first time the dermatology specialist has forayed into biologics, a class of products it has eschewed in the past to keep its focus on topical therapies. Chugai will continue to handle manufacturing of the drug. Once the deal with Galderma is complete, Chugai will retain control of the drug in Japan and Taiwan, leaving its new Swiss partner to take up development in the rest of the world. By broadening its dermatology pipeline into biologics, Once the deal with Galderma is complete, Chugai will retain control of the drug in Japan and Taiwan, leaving its new Swiss partner to take up development in the rest of the world. Genexine out of Korea raised $70 million from a combination of 14 Korean investors, its China partner Tasly Pharma and one other non-Korean investor. In 2015, Tasly acquired China rights for three novel Genexine drug candidates in a deal worth as much as $100 million, plus Tasly paid an unspecified amount for global rights to in-license two other drugs. Genexine, which has three drug candidates in clinical trials, focuses on treatments for cancer and orphan diseases based on its long-acting Fc fusion and therapeutic DNA technologies GSK FDA publishes June 30 Warning Letter linked below states that during an FDA inspection of the company's Clarendon Road, Worthing, UK facility on July 2-10, 2015, FDA investigators identified significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). Hansa Medical announced the acquisition of UK based Immago Biosystems Ltd, a University of Oxford-spinout focused on the enhancement of antibody based cancer therapies using antibody-modulating enzymes. The founders of Immago Biosystems, Dr Chris Scanlon and Dr Max Crispin at the Glycoprotein Therapeutics Laboratory, at the University of Oxford, have discovered that IgG-antibody modulating enzymes can enhance the efficacy of antibody based cancer treatments. Hansa Medical announces that the company sponsored pivotal multicenter study in the US with IdeS in refractory highly sensitized patients is open for recruitment, which is to include ~ 20 highly sensitized patients awaiting kidney transplantation, who are refractory to currently

available desensitization strategies. The primary objective of the study is to assess the efficacy of IdeS in creating a negative crossmatch test. The trial will also evaluate safety, kidney function and immunogenicity during the 6-month follow-up period. The aim is to complete recruitment of approximately 20 patients over a 12-month period. Study results could potentially form the basis for filing a Biologics License Application, i.e. an application to the FDA for authorization to commercialize IdeS in the US. Hansa Medical is currently evaluating the possibility to add European sites to this now initiated study in order to support the regulatory process at the European Medicines Agency, EMA, for marketing authorization of IdeS in the European market. HUM U.S. antitrust officials are poised to file lawsuits to block Cigna/Anthem, Humana/Aetna, according to a person familiar with the matter. Final decision could come as soon as this week INCY announces that updated data from the Phase 1 portion of the ECHO-202/KEYNOTE-037 trial has been accepted for a poster discussion at the European Society for Medical Oncology (ESMO) Annual Congress 2016. The poster will take place Oct 10 2016 from 11:00-12:00 CET The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. IMGN is meeting with FDA this summer to finalize design of Phase 3 trial Forward I in folate receptor alpha-positive platinum-resistant ovarian cancer, according to BI’s Grace Guo’s catalyst calendar IMGN may present data from expansion cohort of Phase 1 trial in folate receptor alpha-positive relapsed/refractory endometrial cancer in 2H 2016 IMNP announced today that it has entered into an amended agreement with NPT, a syndicate of experienced healthcare investors, on July 18, 2016. According to the amended agreement Immune will form a pain-neurology subsidiary, which will own AmiKet® intellectual property. NPT plans to make the first tranche of its investment into the new subsidiary upon closing based on the pre-agreed terms. The parties have agreed to a target closing date of September 15, 2016.Dr. Daniel Teper, CEO of Immune commented: "This is an important step towards realizing the significant value of AmiKet® for Immune's shareholders, and will allow the company to focus on its core immunology and immuno-oncology pipeline." IONS gets $10m milestone from JJN under 2015 accord Ionis Pharma earned $10m from J&J’s Janssen Biotech for IONIS-JBI1-2.5, oral antisense drug for the treatment of a gastrointestinal autoimmune disease. JNJ will assume global development, regulatory and commercialization responsibilities for product once Ionis completes IND-enabling studies ISRG updates full year 2016 procedure growth guidance +14-15% vs prior +12-14% - conf. call Additional FY 16 guidance: ~ 652K procedures were performed in FY 2015 Gross profit margin expected to be 70-71% vs prior 69-70% Expects operating expenses unchanged +12-15% y/y range Anticipates fewer lease buyouts and lower upgrade and other systems revenue in Q3 and Q4 than in Q2 Second half system ASPs will be lower than in Q2 due to product and channel mix Other income ~$30M Japan Tobacco makes inroads article in WSJ, introduces low price brand as legal risks fade and prices rise JNJ worldwide sales increased by 8.9% in the second quarter compared to a year prior, with $8.7 billion in overall sales. U.S. pharmaceutical revenue jumped higher, growing by 13.2%, while international sales growth was more muted. Four drugs drove growth for the drugs unit: altogether Imbruvica, Xarelto, Stilara and Simponi pulled in $637 million in new revenue,

representing 90% of overall sales growth. Notably, sales of Stilara hit $570 million, while Imbruvica recorded a 91.6% in worldwide growth as Q2 sales nearly doubled to $295 million. But Johnson & Johnson's litigation costs also skyrocketed last quarter, totaling $600 million prior to tax adjustments—a 326% increase from the $141 million spent prior to tax adjustments for litigation in 2015. The company has many reasons to be optimistic: U.S. sales grew by a marked amount last quarter; the pharmaceutical subsidiary secured approval of Darcylex, Trevicta and an additional Imbruvica indication in the EU; the FDA granted yet another breakthrough indication to Imbruvica; and pipeline clinical trials are advancing with few setbacks, according to the conference call this morning. But buried in the details JNJ reported increases litigation expenses as the company faces numerous lawsuits over Risperdal-induced gynecomastia and a potential link from their talcum powder to ovarian cancer. According to financial statements, the company spent $600 million in litigation costs last quarter before tax considerations. This is sharply higher than the $66 million in expense reported last quarter and over four times the total from last year.Of course, the reported expenses are shared across all J&J subsidiaries and this quarter's uptick in litigation expenses may just be a return to the norm. In 2014, the company reportedly paid $1.1 billion in litigation before provisions for taxes on income, and in 2013 litigation costs surpassed $2 billion according to the company's annual reports, BioPharm Dive JNJ comments “We continue to see good momentum through the first half of 2016, delivering solid results in the second quarter, supported by strong underlying growth across our enterprise. We saw notable strength in our Pharmaceuticals business due to the continued success of new products, and also achieved significant clinical milestones, advancing our robust pipeline. In our Consumer business, we are executing strategic portfolio decisions to expand our market leadership in key segments, and in Medical Devices, we are continuing to accelerate our growth driven by new product launches and transforming our commercial models." JNJ news that IONS gets $10m milestone from JJN under 2015 accord Ionis Pharma earned $10m from J&J’s Janssen Biotech for IONIS-JBI1-2.5, oral antisense drug for the treatment of a gastrointestinal autoimmune disease. JNJ will assume global development, regulatory and commercialization responsibilities for product once Ionis completes IND-enabling studies Jounce Therapeutics to get $225m upfront, $36m equity investment from Celgene in immuno-oncology license pact. Jounce may also get regulatory, development, sales milestone worth up to $2.3b, tiered royalties on ex-US sales Accord includes options on Jounce lead product candidate JTX-2011 and up to 4 early-stage immunotherapies from programs targeting B cells, T cells and tumor-associated macrophages Jounce, Celgene would split U.S. profits 60%/40% respectively for JTX-2011, next product 25%/75% and 50%/50% for up to three more products LLY FDA has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). Synjardy, from Boehringer Ingelheim and Eli Lilly and Company (LLY), is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate. LPCN is cutting a third workforce Lipocine sees $135,000 in restructuring costs, mostly recognized during Sept. 30 quarter; expects $1.7m in annual cost savings. MDT Medtronic receives CE Mark for new Guardian Connect mobile continuous glucose monitoring system The system will be launched on a country-by-country basis in Q2 of fiscal year 2017, beginning with select countries in Europe, Asia Pacific, and Latin America.

MON views Bayer’s revised proposal as financially inadequate; remains open to talks Monsanto announced that its board unanimously views Bayer AG’s revised proposal as financially inadequate and insufficient to ensure deal certainty. Monsanto remains open to continued and constructive conversations with Bayer and other parties to assess whether a transaction that the board believes is in the best interest of Monsanto shareowners can be realized. There is no assurance that any transaction will be entered into or consummated, or on what terms. MON Corvex building small stakes in MON and BAYER Mazor Robotics announces comprehensive data from two studies demonstrating significant clinical benefits of its surgical guidance technological platform (3818.00a) The first study is titled, “Surgical Outcomes of Robotic-Guidance vs. Freehand Instrumentation – A Retrospective Review of 705 Adult Degenerative Spine Patients Operated in Minimally Invasive (MIS) and Open Approaches.” The data showed that in the hands of experienced MIS surgeons, the use of robotic guidance in MIS approach can significantly reduce surgical complications and revision surgeries when compared to fluoro-guided MIS. The study revealed a three-fold higher rate of complications in both the freehand MIS and freehand open cases, compared to the Renaissance-guided cases. The revision rate was 3.8-times higher in the freehand MIS cases than in the Renaissance MIS cases. All the results were statistically significant. Mazor Robotics news that their second study, titled: First Report From MIS ReFRESH: A Prospective, Comparative Study of Robotic-Guidance vs. Freehand Pedicle Screw Placement in Minimally Invasive Lumbar Surgery provided data which was reported by Mazor Robotics in May. While these are preliminary results from an ongoing, prospective, controlled, multi-center study, data showed that use of Mazor Robotics surgical guidance in MIS significantly reduced the complication and revision rates compared to freehand MIS cases. MYL and PULM report positive pharmacokinetic bioavailability data in pilot study of PUR0200 PUL Pulmatrix has announced positive topline data from a Phase 1 pilot pharmacokinetic bioavailability trial of PUR0200. Under the terms of an agreement with Mylan, Pulmatrix led the pilot pharmacokinetic clinical study and supportive development work with collaborative support from Mylan. Mylan has retained an option for PUR0200 ex-U.S. rights based on successful completion of the clinical study. : There were no serious adverse events and the safety profile of PUR0200 was comparable to that of the reference product. Of the 42 enrolled subjects, 41 completed all dosing periods. NAVB has received Institutional Review board (IRB) approval from the University of California, San Francisco School of Medicine for a clinical study examining the ability of Lymphoseek (technetium Tc 99M tilmanocept) injection, a Manocept platform product, to specifically identify active rheumatoid arthritis (RA) in pre-identified RA-affected joints. The study will begin enrolling patients shortly. Additionally, Navidea has received WIRB IRB approval to expand this study to other study sites at Navidea’s discretion. NEOSTELL SAS news that NEOVACS and SBOT STELLAR BIOTECHNOLOGIES announced the start of their joint venture company, Neostell SAS, with the holding of its first general assembly. At the meeting, the bylaws for Neostell were approved and the Administrative Board and management team were appointed.The following executives were appointed to the Administrative Board: Bernard Fanget, (Vice President Pharmaceutical Development, Neovacs); Frank Oakes (CEO, Stellar Biotechnologies) and Miguel Sieler (CEO, Neovacs).In addition, the management team will include Bernard Fanget as Chairman of the Board of Directors and President and Olivier Dhellin as CEO. Both also will remain in their current positions at

Neovacs. Mr Fanget and Mr Dhellin’s experiences in the pharmaceutical industry are essential assets to oversee and ensure the efficient launch of the joint venture production company. Their first mission at Neostell will consist of identifying and reserve trough an option agreement a site for the manufacturing facility. However, major investment in the joint venture will not occur until after the results of the Neovacs ongoing Phase IIb trial with IFNa Kinoid in the treatment of lupus are known NVS said profit may fall this year as the Swiss drugmaker increases spending on the heart medicine Entresto and faces declining sales of its best-selling cancer treatment Gleevec. Core operating income will either be about the same as 2015 or decline by a percentage in the low single digits at constant exchange rates, Novartis said Tuesday in a statement. Sales will show little change. NEOVACS and SBOT STELLAR BIOTECHNOLOGIES announced the start of their joint venture company, Neostell SAS, with the holding of its first general assembly. At the meeting, the bylaws for Neostell were approved and the Administrative Board and management team were appointed.The following executives were appointed to the Administrative Board: Bernard Fanget, (Vice President Pharmaceutical Development, Neovacs); Frank Oakes (CEO, Stellar Biotechnologies) and Miguel Sieler (CEO, Neovacs).In addition, the management team will include Bernard Fanget as Chairman of the Board of Directors and President and Olivier Dhellin as CEO. Both also will remain in their current positions at Neovacs. Mr Fanget and Mr Dhellin’s experiences in the pharmaceutical industry are essential assets to oversee and ensure the efficient launch of the joint venture production company. Their first mission at Neostell will consist of identifying and reserve trough an option agreement a site for the manufacturing facility. However, major investment in the joint venture will not occur until after the results of the Neovacs ongoing Phase IIb trial with IFNa Kinoid in the treatment of lupus are known NVS said profit may fall this year as the Swiss drugmaker increases spending on the heart medicine Entresto and faces declining sales of its best-selling cancer treatment Gleevec. Core operating income will either be about the same as 2015 or decline by a percentage in the low single digits at constant exchange rates, Novartis said Tuesday in a statement. Sales will show little change. NVS Sandoz unit says it received CRL for its Neulasta biosimilar of AMGN product, NVS in today's earnings release, NVSs disclosed that its Sandoz unit received a Complete Response Letter (CRL) from the FDA for its biosimilar pegfilgrastim candidate (Neulasta, AMGN). The company says it is working with the FDA to address remaining questions with the application for LA-EP2006 ONTX announced the enrollment of the first patient in Japan by SymBio Pharmaceuticals in the global Phase 3 INSPIRE trial, investigating IV rigosertib as a treatment for higher-risk myelodysplastic syndromes following failure of hypomethylating agent therapy. SymBio licensed rights to rigosertib from Onconova for Japan and Korea in 2011 and has completed two Phase 1 trials in Japan. The INSPIRE pivotal trial is now open for patient enrollment in more than 90 sites in the U.S., Europe, Canada, Australia, Israel and Japan. ORMP marking a pivotal moment in the growing relationship between China and Israel, the biggest pharma licensing agreement between the two countries recently took another step forward. Jerusalem-based Oramed Pharmaceuticals Inc. received the first milestone payment from its license and investment agreement with Hefei Tianhui Incubator of Technologies Co. Ltd., of Hefei, China. The deal, which took three years to complete, underlines the demand in

China for effective diabetes treatments as well as the growth of companies in Israel, article in BW. PFE the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). WHO prequalification allows for the global use of Prevenar 13 MDV by United Nations agencies and countries worldwide that require WHO prequalification. The prequalified MDV presentation is expected to be introduced under the Advance Market Commitment (AMC) program in early 2017, for shipment to countries supported by Gavi, the Vaccine Alliance (Gavi). In January 2015, during Gavi’s pledging conference, Pfizer began to prepare for the potential introduction of Prevenar 13 in the MDV presentation by announcing a 20 cent reduction in cost, from $3.30 per-dose to $3.10 per-dose, in its MDV per-dose price for Gavi-eligible countries. Once the MDV presentation is introduced under the AMC, this pricing is expected to be available to all Gavi-eligible countries. In addition, expanded availability will enable Gavi-graduated countries to access the same pricing until 2025. PGNX FDA approves VRX Valeant's Relistor tablets for OIC Under the 2011 Salix-Progenics collaboration, Progenics is entitled to up to $50M upon approval of an oral Relistor product in the U.S. VRX PMCB recently received some good news in the form of patent protection that will help the company do its part in bringing a treatment to tens of millions of these patients. PharmaCyte recently learned from the U.S. Patent and Trademark Office (USTPO) that it now has 20 years of patent protection in the United States for the "Melligen" cells that are a part of the company's therapy for Type 1 and insulin-dependent Type 2 diabetes. The timing is perfect because the same research that laid out the dramatic rise in the numbers of people affected by diabetes, also found that the global cost of diabetes has ballooned to $825-billion per year. These staggering numbers come from the largest study ever done on diabetes levels across the globe. The study was published in the journal The Lancet and was led by scientists from Imperial College London, and involved Harvard T.H. Chan School of Public Health, the World Health Organization, and nearly 500 researchers across the globe, and it incorporated data from 4.4 million adults in most of the world's countries. PharmaCyte's therapy for diabetes is made up of its signature live-cell encapsulation technology Cell-in-a-Box®, which are pinhead-sized, porous capsules that are filled with insulin producing cells (Melligen cells). The capsules would protect the Melligen cells from destruction by the immune system and, in turn, would essentially create an "artificial pancreas" for type 1 diabetics and insulin-dependent type 2 diabetics that no longer produce their own insulin. PRQR announced that the FDA granted Fast Track Designation to the company's molecule QR-010 for the treatment of patients with CF due to the ∆F508 mutation. Top-line data from the 16 patients in Study PQ-010-002 is expected to be presented during the NACFC Oct 27-29 2016. PULM and MYL report positive pharmacokinetic bioavailability data in pilot study of PUR0200 PUL Pulmatrix has announced positive topline data from a Phase 1 pilot pharmacokinetic bioavailability trial of PUR0200. Under the terms of an agreement with Mylan, Pulmatrix led the pilot pharmacokinetic clinical study and supportive development work with collaborative support from Mylan. Mylan has retained an option for PUR0200 ex-U.S. rights based on successful completion of the clinical study. : There were no serious adverse events and the safety profile of PUR0200 was comparable to that of the reference product. Of the 42 enrolled subjects, 41 completed all dosing periods.

RHHBY Chugai Pharmaceutical news that Galderma Pharma has picked up the rights to a midphase atopic dermatitis and pruritus drug from Roche’s Chugai Pharmaceutical. The deal gives Galderma an exclusive license to develop and market the drug, the first biologic in its portfolio, in all countries except Japan and Taiwan.Galderma is committing to upfront, milestone and royalty payments of an undisclosed amount to gain the rights to the drug, the anti-IL-31 receptor A humanized monoclonal antibody nemolizumab. The addition of nemolizumab to Galderma’s pipeline marks the first time the dermatology specialist has forayed into biologics, a class of products it has eschewed in the past to keep its focus on topical therapies. Chugai will continue to handle manufacturing of the drug. Once the deal with Galderma is complete, Chugai will retain control of the drug in Japan and Taiwan, leaving its new Swiss partner to take up development in the rest of the world. SBOT STELLAR BIOTECHNOLOGIES and NEOVACS announced the start of their joint venture company, Neostell SAS, with the holding of its first general assembly. At the meeting, the bylaws for Neostell were approved and the Administrative Board and management team were appointed.The following executives were appointed to the Administrative Board: Bernard Fanget, (Vice President Pharmaceutical Development, Neovacs); Frank Oakes (CEO, Stellar Biotechnologies) and Miguel Sieler (CEO, Neovacs).In addition, the management team will include Bernard Fanget as Chairman of the Board of Directors and President and Olivier Dhellin as CEO. Both also will remain in their current positions at Neovacs. Mr Fanget and Mr Dhellin’s experiences in the pharmaceutical industry are essential assets to oversee and ensure the efficient launch of the joint venture production company. Their first mission at Neostell will consist of identifying and reserve trough an option agreement a site for the manufacturing facility. However, major investment in the joint venture will not occur until after the results of the Neovacs ongoing Phase IIb trial with IFNa Kinoid in the treatment of lupus are known SCLN talks ended without an offer the board was “willing to pursue;” plans to remain independent, will continue to explore options.No bids reflected premium to recent trading Servier Vernalis Gets Milestone Payment From Servier in Cancer Pact Reaching milestone triggers a payment of EU500,000 to Vernalis. Collaboration uses Vernalis’s proprietary fragment and structure-based drug discovery platform on a number of oncology targets, including Bcl-2 and Mcl-1 SELB announced two gene therapy programs for rare genetic disorders of metabolism, Methylmalonic Acidemia (MMA) and Ornithine Transcarbamylase Deficiency (OTC). Both of these gene therapy programs will use Selecta’s proprietary SVP-Rapamycin (SEL-110) immune therapy, which is designed to enable repeated gene therapy dosing. Selecta believes a solution for repeat gene therapy dosing has the potential to significantly expand the number of diseases that could be treated with gene therapy, particularly in the case of pediatric patients. Sinclair Pharma there has been no immediate impact on the company's day-to-day operations following the UK's referendum vote to leave the European Union. However, foreign exchange movements are expected to have a positive impact on reported revenues. Approximately 60% of the group's current year sales are in Euros and 25% in US Dollars. With the majority of the group's overheads also outside the UK, including the investment in the Instalift launch in the US, the impact on earnings is expected to be broadly neutral in 2016. STENTYS has commenced enrolling patients in the TRUNC trial, which is designed to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main coronary artery disease

SYMBIO news that ONTX announced the enrollment of the first patient in Japan by SymBio Pharmaceuticals in the global Phase 3 INSPIRE trial, investigating IV rigosertib as a treatment for higher-risk myelodysplastic syndromes following failure of hypomethylating agent therapy. SymBio licensed rights to rigosertib from Onconova for Japan and Korea in 2011 and has completed two Phase 1 trials in Japan. The INSPIRE pivotal trial is now open for patient enrollment in more than 90 sites in the U.S., Europe, Canada, Australia, Israel and Japan. TEVA completed the pricing of a $15 billion bond offering, intended to help it to finance the acquisition of the generics division of Allergan plc. Reuters reported yesterday that the offering had attracted demand of $70 billion. Teva's debt offering, via by its special purpose finance subsidiary Teva Pharmaceutical Finance Netherlands III B.V., consists of the following tranches $1.5 billion of 1.400% fixed rate senior notes maturing in 2018; $2.0 billion of 1.700% fixed rate senior notes maturing in 2019; $3.0 billion of 2.200% fixed rate senior notes maturing in 2021; $3.0 billion of 2.800% fixed rate senior notes maturing in 2023; $3.5 billion of 3.150% fixed rate senior notes maturing in 2026; and $2.0 billion of 4.100% fixed rate senior notes maturing in 2046. The notes will be sold at a price of 99.914%, 99.991%, 99.835%, 99.666%, 99.734% and 99.167% of the principal amount thereof, respectively, and will be guaranteed by Teva Pharmaceutical Industries Limited. The company says that additional senior, unsecured benchmark-sized offerings of euro and/or Swiss franc CHF-denominated multi-tranche debt securities are contemplated, subject to market conditions. Teva originally planned the offering for the fourth quarter it has a bridging bank loan that gives it flexibility over the timing but brought the timetable forward because of the low interest rate environment. Teva also published its multi-year guidance last week, earlier than expected, even though it had not yet completed the Allergan deal. Teva is paying $35.1 billion net and nearly $40 billion gross for Allergan generics division Actavis. The companies are still waiting for approval from the US Federal Trade Commission in order to complete the deal signed a year ago. Teva CFO Eyal Desheh said, “The strength of the demand, which was multiple times the size of the offering, and the attractive prices, are a testament to Teva's financial strength and strong reputation with investors.” Teva says that the net proceeds from this offering will be approximately $14.9 billion, after the underwriting discounts and estimated offering expenses. As mentioned Teva intends to use the net proceeds from this offering towards the cash portion of the purchase price for its previously announced acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”), to pay related fees and expenses, and/or otherwise for general corporate purposes. Closing of the offering is expected on July 21, 2016. VBIV applies eVLP Platform in the development of a novel vaccine VBI is developing a bivalent Zika vaccine candidate prevent Zika Virus VBI is developing a bivalent Zika vaccine candidate consisting of E glycoprotein (found on the surface of Zika virus) and NS1 glycoprotein (secreted during Zika viral replication). During recent testing, VBI used a cell entry assay to confirm the presence of E glycoproteins on the surface of its Zika eVLPs; the conformation was found to be suitable for receptor binding and cell entry. VMW news that DELL EMC shareholders back $ 62 billion takeover offer with DELL, VMW will own < than 50 % of the company and the cash portion of the offer will leave DELL with nearly $ 50 billion in debt prompting them to sell non core businesses VRML Vermillion's ASPiRA Labs announces strategic Michigan coverage for OVA1 Announced an agreement with Priority Health Managed Benefits, a Michigan healthcare insurance company, for coverage of ASPiRA LABS' ovarian cancer risk assessment test, OVA1.

Management comments: "We are pleased to announce OVA1 payer coverage with Priority Health," said Valerie Palmieri, President and CEO of Vermillion, Inc. "A positive ovarian cancer outcome starts with early detection and the right treatment, at the right time, for the right patient, and results in improved healthcare efficiencies. The mortality rate of ovarian cancer has not changed in 40 years, even following the introduction of CA125. Expanding access to OVA1 is key to our fundamental mission to serve women at an elevated risk for ovarian cancer. This contract is part of our campaign to pursue managed care coverage agreements throughout 2016. We hope to expand OVA1 test adoption, further build our data repository and expansion of our clinical studies to demonstrate the 'total cost of care' benefit of OVA1 to healthcare systems." Vernalis Gets Milestone Payment From Servier in Cancer Pact Reaching milestone triggers a payment of EU500,000 to Vernalis. Collaboration uses Vernalis’s proprietary fragment and structure-based drug discovery platform on a number of oncology targets, including Bcl-2 and Mcl-1 VRX FDA approves Valeant's Relistor tablets for OIC PDUFA for oral formulation of Relistor for opioid-induced constipation (OIC) was Jul 19 2016 Progenics (PGNX) out-licensed rights to Salix Pharma, now Valeant, and is entitled to milestones and royalties. Sales of Relistor tablets are expected to commence in Q3 2016

VRX FDA panel votes to support approval of Valeant's brodalumab for treatment of plaque psoriasis The panel voted 4 A 14 B 0 C Full question: Is the overall benefit/risk profile of brodalumab acceptable to support approval for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy? a. Yes, with labeling alone to manage the risks b. Yes, but only if certain risk management options for SIB beyond labeling are implemented c. No Please provide a rationale for your vote. If you voted for A, please describe the labeling you would recommend to manage the risks. If you voted for B, describe the interventions or tools you believe would help mitigate the risk of SIB, in addition to labeling YHOO in NY Post party is over article , sale looks imminent as results disappoint YHOO IBD article: Yahoo’s search advertising business struggled again in Q2 -- no surprise there. But the reason why Yahoo mentioned Apple (AAPL) in connection with its search business on its earnings call is a mystery, says Macquarie Securities. Yahoo's net search revenue declined 23% from the year-earlier quarter, to $319 million. Like Alphabet's (GOOGL) Google, Yahoo has been transitioning to mobile. "In our view, if Yahoo can't somehow turn around search, it is going to struggle to grow margins meaningfully," Ben Schachter, a Macquarie Securities analyst, said in a research report. "If we are able to get more clarity on why the company mentioned Apple in regards to search, or if we learn that Facebook's (FB) Audience Network is being deployed more broadly, that may be of interest to shareholders." Yahoo CEO Marissa Mayer cited Apple as a search partner. "With search making up more than half of our GAAP revenue, it remains an important area of our business," said Mayer on the company's earnings conference call. "Today, our search business is built on strong partnerships with Microsoft (MSFT), Google, Mozilla, Apple and Oracle (ORCL), among others." In late 2014, Yahoo signed a deal with privately held Mozilla to replace Google as Mozilla's default U.S. search engine. And Yahoo renewed its search partnership with Microsoft in April 2014. Evan Wilson, a Pacific Crest Securities analyst, said in a report late Monday that Yahoo's search advertising business continues to struggle. "Yahoo blames the transition to mobile, but it

is clear that its technology improvements and Microsoft and Firefox deals have not been able to turn around this very important revenue driver," Wilson wrote. Yahoo also says its Tumblr social network has started using Facebook Audience Network for advertising. Google's search engine is the default on most mobile devices, and it's the default search engine for Apple's Safari browser. However, there has been speculation over whether Apple and Google will renew the Safari contract, or whether they have modified it. Yahoo late Monday reported Q2 revenue that edged above views, but its earnings missed. Yahoo had little to say on the sale of its core internet business, a process that has dragged on longer than some observers expected. "I can say we are deep into the process, evaluating proposals and alternatives, and will update our shareholders as soon as is prudent," Mayer said. Verizon Communications (VZ), which bought AOL last year, remains the front-runner to buy Yahoo's internet business, many analysts say. ZFGN refocuses resources on development of second-generation MetAP2 inhibitor ZGN-1061 Following a comprehensive review of its assets and clinical programs, as well as feedback from regulatory authorities, the company is refocusing its resources on development of a differentiated second-generation MetAP2 inhibitor, ZGN-1061, in severe and complicated obesity. Given the heightened complexity and future cost of beloranib development, the IND for which was placed on full clinical hold in December, balanced against the emerging product profile of ZGN-1061, the company believes that the long-term opportunity for ZGN-1061 is more robust than for beloranib. Zafgen is currently screening patients to initiate a Phase 1 clinical trial evaluating ZGN-1061 for safety, tolerability, and weight loss efficacy over four weeks of treatment, and currently expects Phase 1 clinical data by the end of Q1 of 2017. Based on the clinical data demonstrating beloranib’s significant effect on body weight and glycemic control in patients with severe obesity complicated by type 2 diabetes, Zafgen plans to focus later-stage development of ZGN-1061 in severe and complicated obesity. As part of the strategic restructuring, the company plans to reorganize its operations, and Zafgen’s workforce is being reduced by approximately 34%, to a total of 31 employees, by December 2016. Zafgen expects the restructuring to result in approximately $4.8M in reduced annualized workforce expenses once the plan is fully implemented. The. In addition, both Patrick Loustau, President, and Alicia Secor, Chief Commercial Officer, will be leaving the company to pursue other opportunities. Zafgen ended 30-Jun-16 with approximately $150.5M in cash and cash equivalents and now expects to end 2016 with greater than $125M. The company believes that its current cash balance is sufficient to fund operations through the end of 2018, at which time it expects to have completed a Phase 2a clinical trial for ZGN-1061. ZIOP news that the patient death in phase I study of Ad-RTS-hIL-12 in brain cancer deemed unrelated to study drug The patient death resulting from intracranial hemorrhage in the third cohort of this Phase I study was deemed unrelated to study drug following the receipt and analysis of additional information by the sponsor and the study’s Safety Review Committee. The company expects to provide further updates on the progress of the study, including longer-term survival follow up, later this year.

Bioworld Aids experts warn that gains against HIV remarkable, but not irreversible The generally recognized goals with respect to AIDS are the so-called 90-90-90 goals. They state that by 2020, 90 percent of all people living with HIV should know their HIV status, 90 percent of all people with diagnosed HIV infection should receive ART, and ART should lead to viral suppression in 90 percent of those treated. Those goals are intermediates on the way to a goal

of ending AIDS as a global public health threat. In practical terms, that goal is defined as fewer than 200,000 new infections and AIDS related deaths by 2030 Stoffels, chief scientific officer at Johnson & Johnson, said that “The end of HIV in our lifetime, we’re only going to see if we can get a vaccine. There is no other way.” As the long-term work on getting a vaccine is underway, in the short term, it is important to further expand access to ART, use rational combinations of ART, and monitor viral loads during treatment to keep ahead of drug resistance. And a mundane but critical factor is to avoid drug shortages that can lead to involuntary treatment interruptions. If those conditions are met, Stoffels said, “Life expectancy can be normal life minus two years, and maybe even normal life. People can see their kids and their grandkids grow up, if therapy is done well.” BIIB is also affected by the RHHBY GOYA readout as BIIB is Genentech’s anti-CD20 partner, which currently receives a royalty rate of 35 percent to 40 percent on Rituxan and Gazyva sales, marking about $1.3 billion in Cambridge, Mass.-based Biogen’s revenues in 2015, according to Jefferies analyst Brian Abrahams. That translated into about 12 percent of the company’s overall revenue for the year. Losing the current DLBCL market to a biosimilar would be “incrementally negative” for Biogen, Abrahams wrote in a research note. GSK CFDA approves GSKCervarix as China’s first HPV vaccine article EVOK Pivotal trial Evoke’s failure for diabetic gastroparesis drug article ELTP review of the news for Sequestox CRL which had a PDUFA date of last Friday, when the CRL arrived. Along with its Sequestox effort, Elite has eight commercial products on the market, with several more approved that are pending manufacturing site transfer. The firm also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd., of Mumbai, India) and has partnered with Epic Pharma LLC for the manufacturing and distribution of 11 approved products that are pending manufacturing site transfer. Elite has agreements with Akorn Inc., of Lake Forest, Ill., to develop an intermediate for a generic product, and with a Hong Kong-based company to develop a branded product for the U.S. market and its territories. Although the latest news for Sequestox is unwelcome, “ Hakim said that does not mean we will not comply 100 percent with their requirements.” He noted that the CRL contains seven highlights but “only one that really was critical for the product. The silver lining in this whole disappointing issue is that the FDA made no comment about the release technology, because it works and is solid,” which is “great news” for the platform. Hitches in drug development are to be expected, he said. “We don’t roll over and play dead. We solve them and move on.” Elite is in the “best financial shape ever in its history,” with the “best talent and best pipeline ever,” Hakim said, and the company aims to file a drug application “every quarter through 2017 and beyond. My goal is to file, at the minimum, six applications by the end of next year. We will keep you updated as the FDA responds, and we will talk to you in August.” // Pharming Ruconest scores in HAE prophylaxis trial The timing of an approval of Ruconest in the prophylaxis setting is not yet clear – Valeant and Pharming will need to have talks with the FDA to determine the next steps, de Vries said. SHPG continues to dominate the market, with total sales of more than $1 billion in 2015. It entered the HAE field through the acquisitions of Cinryze developer Viropharma Inc. for $4.2 billion in 2013 and of Firazyr (icatibant) developer Jerini AG for $521 million in 2008, respectively. Cinryze, which is indicated for both acute and prophylactic use, attained total sales of $618 million in 2015, while Firazyr, a bradykinin receptor antagonist, which is approved for acute use only, delivered another $445 million. Ruconest, in contrast, has

struggled to make headway, followings its approvals for treating acute attacks in Europe and the U.S. in 2010 and 2014, respectively. . RHHBY Gazyva (obinutuzumab) considered to be a follow-on for blockbuster Rituxan (rituximab), failed to improve progression-free survival (PFS) in a head-to-head study with Rituxan, when both were given with CHOP chemotherapy, in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Detailed data won’t be unveiled until a future medical meeting, but the miss in the DLBCL trial, dubbed GOYA, are particularly disappointing given Gazyva’s track record to date. In 2013, it became the first drug to win FDA approval under the breakthrough therapy designation, indicated for previously untreated patients with chronic lymphocytic leukemia (CLL) as part of a combination regimen with chemotherapy chlorambucil. And earlier this year, use of the drug, a glycol-engineered type 11 humanized monoclonal antibody targeting CD20, was expanded to include follicular lymphoma (FL) patients who either failed to respond to a Rituxan-containing regimen or whose FL returned after treatment. That approval was based on impressive data from the GADOLIN study, stopped early in 2015 after Gazyva plus Treanda (bendamustine, Teva hit the PFS endpoint. And in May, a phase III study, GALLIUM, reported positive data for Gazyva in the first head-to-head experiment with Rituxan. Gazyva plus chemotherapy followed by Gazyva alone significantly improved PFS compared to Rituxan plus chemo followed by Rituxan alone in patients with previously untreated FL (p < 0.0001). After the top-line GALLIUM readout, expectations were high for the GOYA study. It is too early to determine why the GOYA study did not meet its primary endpoint, aggressive and indolent blood cancers are clinically and biologically distinct diseases, with different characteristics, prognosis and treatment regimens The original hope was that a successful GOYA result would have enabled Gazyva to become the preferred treatment over Rituxan in the DLBCL setting and so help protect the Rituxan franchise from biosimilars says Jefferies which DLBCL at about 27 percent of the overall oncology sales for Rituxan, which faces patent expiration in the U.S. in 2018 – the patent already has expired in Europe. But analysts noted the GOYA results could cast a pall over GALLIUM data, too. The indolent (iNHL) space, of which FL is the most common subtype, represents a much bigger piece of the addressable market for Gazyva – about 49 percent, according to Jefferies. DLBCL a fast-growing type of NHL is known for its high relapse rate – as many as 40 percent of patients will relapse – and roughly 24,000 new cases will be diagnosed in the U.S. this year. The GOYA study included 1,418 previously untreated patients with CD20-positive disease. Secondary endpoints included PFS assessed by an independent review committee, response rate, overall survival, disease-free survival and safety. Genentech has no other studies pitting Gazyva against Rituxan, though the firm is aware there are investigator-sponsored trials in combination with chemotherapy, There are combination studies ongoing, testing Gazyva “across a range of blood cancers with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors.Among those is a phase III study testing Gazyva in combination with approved Bcl-2 inhibitor Venclexta (venetoclax) plus chlorambucil in CLL patients. A phase I/II study is ongoing testing two regimens – Gazyva, polatuzumab vedotin (an antibody-drug conjugate targeting CD79b) and Treanda or Rituxan, polatuzumab vedotin and Treanda – in relapsed/refractory FL or DLBCL VRX on the margin brodalumab is headed toward approval, A review of the incidence of and risk factors for SIB undertaken by the FDA’s Division of Biometrics concluded that brodalumab

users with a history of depression or suicidal ideation had a much greater increase in SIB incidence rate – a 12- to 18-fold increase for those with a history of suicidality – compared to users without those risk factors. The agency’s Division of Pharmacovigilance (DPV), after detailing the six suicides, nevertheless reported that, “from the available data, we cannot conclude whether or not suicide is a drug-related risk. These populations have a highly elevated risk of psychiatric disorders and symptoms, including SIB. The controlled data do not suggest that neuropsychiatric adverse events are drug-related; however, the controlled phases were relatively short, and there was limited ability to ascertain relevant events.” The DPV recommended the agency consider approving brodalumab to treat psoriasis while clearly describing in the label the potential risk of suicide and the relevant study results, emphasizing the absence of an established drug-related risk, or approving brodalumab only as second-line treatment for patients with an inadequate response to other biologic treatments for psoriasis. “Because suicide is a potential risk related to treatment with brodalumab, we could consider potential risk mitigation strategies,” DPV officials added, but they stopped short of recommending the exclusion of patients with a history of psychiatric disorders for treatment, observing that “a high proportion of patients with psoriasis have psychiatric disorders

PNAS.ORG

The complete resurfacing of synovial joints remains an important challenge for the treatment of osteoarthritis. Here, we develop an anatomically shaped, functional cartilage construct based on a 3D woven scaffold that can provide for total joint resurfacing, with capabilities for tunable and inducible production of anticytokine therapy to protect diseased or injured joints from pathologic inflammation. An important advance of this work is the incorporation of a technique for scaffold-mediated viral gene delivery for overexpression of antiinflammatory molecules within the joint. This approach provides a foundation for total biological cartilage resurfacing to treat end-stage osteoarthritis for young patients, who currently have few therapeutic options.

Biocentury Freeman no longer U.K.'s Minister of Life Sciences The future of the U.K.'s Office of Life Sciences is in doubt now that MP George Freeman has accepted another cabinet position from new Prime Minister Theresa May, ending his term as Minister of Life Sciences. A spokesperson for the Department for Business, Innovation & Skills said the department is still deciding whether to appoint a new Minister of Life Sciences to replace Freeman, whether the Office for Life Sciences will continue, and if so, to whom the office will report. The spokesperson said the department hopes to make a decision this week.Freeman, a former biotech VC, was the first-ever Minister for Life Sciences. He will now be Chair of the Prime Minister's Policy Board. VP of Corporate Affairs and Market Access Rich Bagger has taken a leave of absence from Celgene Corp. (CELG) to work on the transition team for presidential candidate Donald Trump, an industry source told BioCentury. Neither Celgene nor the Trump campaign responded to inquiries.Before joining Celgene, Bagger was chief of staff to New Jersey Gov. Chris Christie, and served as both a New Jersey state senator and assemblyman. Christie and Celgene Executive Chairman Robert Hugin are among New Jersey's Republican delegates who are pledged to support Trump at the Republican National Convention. Bagger is an alternate delegate.

Bio News Texas

Exclusive Interview with Dr. Peter Hotez: Public Health Risks if Zika Funding Stalls in US Congress Exclusive Interview with Dr. Peter Hotez: Potential Long-term Impact of Zika and How Congress Is Letting Ideological Arguments Interfere with Public Health UTHealth Researchers Help Uncover Protective Role for OCT4 in Atherosclerosis Inhaled Ibuprofen for Cystic Fibrosis Treatment Studied at Texas A&M MD Anderson and Hitachi Chemical Collaborate to Focus on Cancer Therapies

STAT on breakthroughs Scientists are speeding toward a new gold standard in hip replacements by using lab-grown cartilage to ease pain in arthritic joints. Scientists took stem cells from patients and grew them into cartilage on a 3-D, biodegradable scaffold that was modeled after a patient’s own troubled joint. Placing the cartilage on top of a joint with arthritis seeds the damaged area with living tissue that can help symptoms subside. Ideally, that could delay or even eliminate a patient’s need for a full hip replacement. The scientists also inserted a gene into that cartilage that can be drug-activated to dispense anti-inflammatory molecules that stave off further development of arthritis. Read the research in PNAS. Scientists have woven microscopic sensors into thread to gather diagnostic data from the tiniest of sutures. The threads are dipped into compounds that can sense physical shifts in factors like temperature, glucose, and blood pressure. Researchers tested the smart thread in rats and found it was able to accurately relay info to a wireless computer. They’re hopeful it could be used to monitor how a stitched-up wound is healing and catch any infections early on.

KHN Kaiser Health News headlines Sometimes Tiny Is Just The Right Size: ‘Microhospitals’ Filling Some ER Needs Soda Taxes: Gaining Steam Or Getting Steamrolled? ‘Don’t Cut Me!’: Discouraged By Experts, Episiotomies Still Common In Some Hospitals Health Officials Probing Mysterious Transmission In Fatal Utah Zika Case California Bracing For Hefty Insurance Rate Increases How Medicare Advantage Plans Factor Into Aetna-Humana Proposed Mega-Merger Advocates Press Missouri Governor To Halt Plan To Move Medicaid To More Managed Care Law Starbucks Will Give Employees Access To Private Insurance Exchange Options Drugmakers Looking At Creative Ways To Attract Patients To Clinical Trials Health Innovations: Tiny Robot Could Mend Stomach Troubles; Growing A Hip Replacement Hospital Roundup: Ransomware Attacks Worry Congress; A Rise In 'Microhospitals' Addiction Law Fails To Adequately Strengthen Opioid Tracking System, Critics Say More Than 1 In 4 LGBT Adults Could Not Afford Food In Last Year: Report Benefits Of Electroshock For Some Depression Patients Outweigh Risks: FDA U.N. Chief: Progress Against AIDS 'Inadequate - And Fragile' Number Of Incurable Prostate Cancer Cases On The Rise: Report

Sydney Morning Herald on HLF and Bronte ‘s John Hempton HLF Herbalife a pyramid scheme? Billionaires at odds over the question Is the company behind nutritional supplement Herbalife selling a pyramid scheme? A decision handed down by US federal regulators on Friday evening was meant to answer the question and end a long-running brawl between some of the biggest names in global finance,

like George Soros.Retired at 39, John Hempton says he co-founded Bronte in 2009 when his wife threatened to divorce him if he didn't get out of the house But one of the key protagonists, Sydney fund manager John Hempton, said the outcome is not so clear. Days after the US Federal Trade Commission handed down its decision, both sides are claiming victory. It is no small matter for billionaire activist investor Bill Ackman who bet as much as US1 billion that the stock would be rendered worthless by an FTC verdict supporting his view that it is a pyramid scheme. Bronte Capital's Hempton has been going toe to toe with Ackman over the years, arguing that Herbalife – which has operations in Australia and is a sponsor of Tony Shepherd's Western Sydney Wanderers FC – is a legitimate business. Soros, Daniel S. Loeb, and prominent Apple investor Carl Icahn have sided with Hempton. They are betting that Herbalife would weather the unprecedented battering by Ackman – a brash hedge fund manager who has spent US50 million on his campaign against Herbalife betting the share price would collapse. The FTC decision has fallen short, so far. It imposed a stiff US200 million fine on Herbalife for deceiving buyers and sellers of its products "into believing they could earn substantial money selling diet, nutritional supplement, and personal care products". "This settlement will require Herbalife to fundamentally restructure its business so that participants are rewarded for what they sell, not how many people they recruit," said FTC chairwoman Edith Ramirez. But it stopped short of shutting down the company. Herbalife said the settlement with the FTC "does not change our direct-selling business model". Herbalife said it agreed to the terms and the fine "because we simply wanted to move forward with our mission". But in a blog post on Sunday, Hempton was wary about claiming victory despite noting the share price spike on Friday that further boosted the value of his investment in Herbalife. "Whilst the settlement is agreed, there are very substantial differences between what effect the FTC says the settlement will have and what effect the company says it will have," said Hempton. "The bull case is thus the government risk has gone away and there will be no substantial change in business model. And the bear case is that the conditions placed are so large they will cause the business to collapse in the US and that those changes will be exported globally." Hempton's clashes with Ackman – they also have opposing positions on Valeant Pharmaceuticals – have made his name globally. But Hempton is just as well known for his unorthodox research. This has included posing as part of a gay couple, trying to buy a home they could not afford, to build his case for short-selling Australian banks. "The further west I went, the more irrational it felt. Lots and lots of supply and prices that bore no resemblance to construction cost and income of people around there," Hempton told Fairfax Media in February of his research that led him to bet against the banking sector.

BioTuesdays on Spartan Bioscience Spartan Bioscience CEO and a co-founder Dr. Paul Lem is interviewed and he has led the closely-held company through FDA and Health Canada approval of the Spartan RX CYP2C19 System, a breakthrough technology that provides fast and inexpensive sample-to-result DNA testing. One-in-three people carry genetic mutations and carrying a CYP2C19 mutation can impair drug metabolism. Some 15% of all prescribed drugs are metabolized by CYP2C19 enzymes, including anti-platelet drugs, anti-depressants and proton pump inhibitors. In May, the

company introduced the Spartan Cube, the world’s smallest commercial molecular diagnostics device that enables unprecedented portability and convenience. The Spartan RX device was FDA-cleared for in vitro diagnostic use, but without a CLIA-waiver, we are only able to target hospitals in the U.S. The Spartan Cube will be our platform for a CLIA-waiver and we’re working on an application and hope to apply to the FDA soon. In Canada, we are expanding into pharmacies, hospitals and doctor’s offices.Spartan Bioscience’s mission is to bring the world’s first personal DNA analyzers to everyone, and a small device makes this possible with portability and convenience. Once DNA testing reaches ease of use, speed and reduced costs, the procedure will be the preferred route for personalized medicine. In the same way that mainframe computers gave way to smartphones, high-throughput mainframe DNA analyzers in central labs will give way to on-demand DNA-testing devices The Spartan Cube is exceptionally small. You can literally hold it in the palm of your hand and it takes up the space of a coffee cup. At only four inches cubed in size, the Cube is portable and fits easily into any space, whether in a hospital, doctor’s office, or pharmacy. The Cube is taking the complexity out of DNA testing and its simple design enables anyone to quickly perform DNA testing. Whether one wants to quickly test a sick patient in a doctor’s office or run a genetic test for drug response, the Cube will provide results when and where you need them. It connects wirelessly to a tablet or laptop that displays test instructions and results with an intuitive touch interface. In addition, the Cube can go from sample-to-result in 30 minutes. That’s a fraction of the time compared with traditional lab-based testing. Doctors, patients, and other users can get immediate results rather than waiting for a lab to run a test. The Cube is a polymerase chain reaction (PCR)-based platform for a variety of molecular diagnostic applications, including infectious disease, pharmacogenetics, and food and water testing for things like E. coli or listeria for environmental monitoring.The Cube connects wirelessly to a tablet or laptop that displays test instructions and results with an intuitive touch interface “We like to think of the Cube as an Xbox with multiple applications. Suppose you had a child at home with sore throat. A cheek swab applied to our strep throat cartridge and inserted into the Cube would determine whether your child has strep throat or not, thereby avoiding a trip to the doctor or emergency room. Flu testing could also be available with the Cube in order to determine whether a fever and chills is flu or not. Our vision is to have cartridges for many of the common ailments that doctors commonly see like strep throat, flu, sexually transmitted infections and personalized drug response information before filling a prescription.”

We will be launching the Cube and an initial assay menu at the American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo in Philadelphia on July 31. It will be priced at about the cost of a personal computer because we want to make it affordable for everyone.

Real Clear Health Tuesday AHA: Extra Caution with Meds after Heart Failure - Rodriguez, WP Antibiotic Use in Dengue May Help Limit Impact of Zika - Branswell, Stat Cold Does Not Increase Chance of Catching a Cold - Aaron E. Carroll, NYT FDA Laxity of Compounded Drugs a Matter of Life, Death - Miller, Forbes FDA: Electroshock, Risky but Useful for Acute Depression - Hurley, WSJ Fight HIV in Two Risky Groups: Sex Workers, Truckers - Beaubien, NPR Fracking May Worsen Asthma for Nearby Residents - Lindsey Tanner, AP

Health and Drug Topics to Watch for at GOP Convention - D. Nather, Stat How Do You Regulate the Digital Health Revolution? - L. Entis, Fortune How Much is Covering the Uninsured Worth? - Chris Conover Medical Mystery: Caregiver of Zika Patient Gets Virus - L. Whitehurst, AP Medicare Fraud Officials Wary of Compound Drug Cost - Appleby, MCN Medicine is Failing Obese People - Farah Naz Khan, Vox UN chief: Progress in AIDS Fight is "Inadequate and Fragile" - Cha, WP

Seeking Alpha positive on FOMX FMX101 remains the company's leading and most promising pipeline candidate and is targeting a $3.7 billion branded moderate-to-severe acne market. The product is a topical foam formulation of minocycline (an antibiotic) for moderate-to-severe acne, which affects approximately 10 million people in the United States. Phase 3 enrollment began in May 2016 and the study is designed as a 12-week, randomized, double-blind, vehicle-controlled, followed by a 9-month open-label extension. There are two co-primary endpoints: These co-primary endpoints were both met with statistical significance in phase 2 trials, and repeating the results in phase 3 trials is more probable. The company plans to report topline data from the blinded phase in 1H 2017, which should be the most important medium-term catalyst for Foamix. The whole study should be completed before the end of 2017 and the company plans to submit an NDA in 2H 2017 with the potential approval and commercial launch in 2H 2018. Foamix intends to build a small, dedicated sales force (50 to 75 reps) and to target the top third of dermatologists responsible for around 80% of total prescriptions.Based on Solodyn's and Epiduo's annual sales run rate of almost $500 million and $300 million respectively, I think that FMX101 has a very good chance to at least match those numbers at the peak in 2020's. Guggenheim's peak sales estimate for FMX101 is $500 million. The rest of the pipeline has the potential to significantly increase shareholder value in the following years The rest of Foamix's pipeline consists of the following candidates: FMX102, a minocycline foam for the treatment of impetigo, including cases caused by MRSA. The company conducted a phase 2 trial with two endpoints: cure or improvement of treated lesions and safety and tolerability. The results showed that 81% of patients demonstrated improvement and lesion clearance at day 3, 92% of patients at day 7 (end of treatment) and 100% at follow-up at day 14. All patients with MRSA were biologically cured at day 7 (end of treatment). The current benchmark, Bactroban, achieves 71% to 96% clinical efficacy within 8-12 days of treatment. I think the numbers are significant enough to warrant a solid share of the market if FMX102 is approved. Foamix had a pre-IND meeting with the FDA in October 2015 and the company has agreed to conduct a photo-safety study as the next step - this should be done in 2H 2016. The impetigo market was worth around $340 million in 2014 and FMX102 is the least attractive candidate in the pipeline, but I think it could generate annual sales in the $50 million to $100 million range, capturing 15% to 30% of the addressable market (assuming no growth of the addressable market). FMX103 has the same active ingredient as FMX101 - minocycline and is being developed for the treatment of papulopustular rosacea, which affects 16 million people in the U.S. alone. Based on the positive data in treating inflammatory acne lesions, the company believes FMX103 can offer advantages over the current standard of care (topical therapies - metronidazole and azelaic acid and oral antibiotics minocycline and doxycycline). The company began enrolling patients in its phase 2 trial - a three-arm, double-blind, randomized, placebo-

controlled trial of two doses of FMX103 (3% minocycline foam and 1.5% minocycline foam) compared to vehicle (placebo). The primary endpoint is the efficacy of FMX103 versus the vehicle. The trial is expected to be completed in 2H 2016 with the results being reported before the end of the year. Rosacea represents a $1.2 billion addressable market and positive trial results could validate this candidate's potential. If the results are positive and if FMX103 shows better efficacy and/or safety, I think it can command at least a 15% to 30% share of the market. FDX104 is a topical foam of the antibiotic doxycycline for the treatment of severe acne-like rashes induced by chemotherapy. This candidate has an orphan drug designation and the company reported positive phase 2 results, which showed a statistically significant effect of FDX104 in reducing the severity of the rash. The company is evaluating the development plan for this product. There are no FDA-approved treatments for this indication and, if approved, FDX104 could command premium pricing and generate meaningful revenues and profits for Foamix in 2020's. In addition to these three pipeline candidates, Foamix also has several preclinical candidates targeting psoriasis, atopic dermatitis, herpes, genital warts, dermatological fungal infections and several other dermatologic conditions. Finacea foam's future royalty stream offers downside protection; collaborations with big pharma companies provide validation of Foamix's foam-based platform Foamix is not your usual development stage biotech. The company has several large pharma collaboration partners and the first product was launched in 2015 and provides validation of the company's foam-based platform. Bayer has successfully launched Finacea foam for rosacea last year and Foamix received $684,000 in royalties in Q1, representing a substantial increase over $254,000 in Q4 2015. Bayer is successfully converting its subscriber base from Finacea gel to Finacea foam and the prescription trends in early Q2 are encouraging and I think that Foamix could end the year with a quarterly royalty stream in a range of $1.5 to $2 million ($6 million to $8 million annualized). The complete conversion from Finacea gel to Finacea foam should result in $10 million+ in annual royalties for Foamix, and this is without any additional growth beyond this conversion, which I think is likely in the next few years.I think that Finacea foam's future royalty streams are worth between $2.3 per share and $3.8 per share, which offers solid downside protection based on the current share price. Of course, getting FMX103 approved could reduce the Finacea foam royalties since the two products will directly compete with each other, but the company can extract more value from a wholly-owned product and this scenario is more desirable for Foamix shareholders. The sum of the parts value per share (including the Finacea foam royalty stream) is $17.5 per share and doesn't take into account the early stage pipeline nor the additional royalty streams from products developed by partners. The sum of the parts PT based on the middle of the estimate range is $30, which is the same as the highest analyst price target (the analyst PT range is between $10 and $30). I believe that I have made very reasonable and perhaps even conservative assumptions regarding the eventual success and peak sales potential for Foamix's pipeline. Pushing the probability of approval higher on all of these candidates (based on successful phase 3 trial results) and getting one or all of the four products approved could lead to significant value creation in the next two-three years. For example, if FMX101 is approved, its conservative net present value would increase from $9 to $15. And these potentially value-creating catalysts are scheduled for the next 6-18 months: FMX103 phase 2 study results in 2H 2016. FMX102 photo-safety study in 2H 2016.

FMX101 phase 3 study results (blinded phase) in 1H 2017 - this is the most important catalyst for Foamix and could move the share price by 50% or more. FMX103 phase 3 initiation in 2H 2017. FMX101 phase 3 study completion in 2H 2017 followed by an NDA filing by year-end 2017 and an eventual approval and launch in 2H 2018. Foamix could be a substantially de-risked stock by mid-2017, depending on FMX101's phase 3 trial results in 1H 2017. FOMX while the company may or may not be attractive as a takeover target in the near-term, successful FMX101 phase 3 trial results could provide further validation for its foam-based platform and could make some large cap pharma companies more interested. PFE acquisition of ANAC is a good enough reason to think that the dermatology space is very attractive, especially if one can get an advantage over competitors through differentiation via improved efficacy and safety in a quite large addressable market. The company may reveal international development plans in the following years, and if it does, it will likely be a partnership as I doubt the company will market these products outside of the U.S. on its own. International expansion is not being valued at all

Patent Docs the USPTO Releases Memorandum on Subject Matter Eligibility On May 4th the USPTO issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update to Subject Matter Eligibility Guidance"). Absent from this analysis was the Federal Circuit's decision in Ariosa v. Sequenom, then on petition for certiorari before the Supreme Court. Since the issue date of this Guidance, the Supreme Court denied certiorari in the Sequenom case, and the Federal Circuit handed down its decision in Rapid Litigation Management v. CellzDirect. Last Friday, the Office issued a Memorandum on these decisions. The Memorandum, under Deputy Commissioner for Patent Examination Policy Robert Bahr's signature, comes right to the point:These cases do not change the subject matter eligibility framework, and the USPTO's current subject matter eligibility guidance and training examples are consistent with these cases. With regard to CellzDirect, the Memorandum cites the Federal Circuit decision as "highlight[ing] several important points." The first is the Court's emphasis on whether a claim is "directed to" a law of nature, which "requires more than 'merely identify[ing] a patent-ineligible concept underlying the claim.'" Rather, the Office understands the CellzDirect decision to require "an analysis of whether 'the end result of the process, the essence of the whole, was a patent-ineligible concept.'" By focusing on "a process for achieving this desired outcome," according to the Memorandum, the Federal Circuit concluded the claims at issue were patent eligible, "like thousands of other claims that recite methods of producing things [the mixed cultures of hepatocytes that were the subject of the claims] or methods of treating disease" (a welcome extrapolation of the Federal Circuit's decision but an extrapolation just the same and one not supported expressly by the Court's decision). The Memorandum also referenced the Federal Circuit's Enfish decision, and asserts that the distinction between the CellzDirect decision and the Sequenom and Supreme Court's Mayo decision was that the latter decisions "amounted to nothing more than observing or identifying the ineligible concept itself." This section of the Memorandum concludes with the statement that "[t]he USPTO's current subject matter eligibility guidance [set out in the 2014 Interim Eligibility Guidance, July 2015 Update, and the May 2016 Update memoranda to examiners] and training examples are consistent with these points." Turning to the denial of certiorari in the Sequenom case, the Memorandum is succinct: its Guidance was consistent with the Federal Circuit's decision, and denial of Sequenom's certiorari

petition changes nothing ("While this panel decision is a precedential Federal Circuit panel decision, the denial of the petition for a writ of certiorari does not elevate its significance in this regard"). The Federal Circuit reasoned in Sequenom that: It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. Sequenom does not contend that Drs. Lo and Wainscoat created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before Drs. Lo and Wainscoat found them. The method ends with paternally inherited cffDNA, which is also a natural phenomenon. The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring. The extent to which these disparate analyses can be reconciled will depend, of course, on future case law, leaving the question of subject matter eligibility in its current state of uncertainty.

San Francisco Chronicle on UCSF CEO Mark Laret and conflicts of interest Mark Laret chief executive of UCSF Medical Center sits on the boards of two companies that together do millions of dollars of business with his hospital and have paid him more than $5 million in stock awards and cash fees since 2007, a review of company filings shows. For his board service, CEO Mark Laret has received an average of $556,000 annually in cash fees and equity from Varian Medical Systems of Palo Alto and Nuance Communications, a Massachusetts software company. That’s on top of the $1.6 million he earns at UCSF as the UC system’s ninth highest-paid employee. UC’s policy on “outside professional activities” for senior managers permits such arrangements if the executives do the extra work on personal time, and if it presents no conflict of interest or the appearance of one. Executives need to get approval each year from their immediate boss, which in Laret’s case is UCSF Chancellor Sam Hawgood.UCSF says there is nothing improper about Laret’s corporate board work and that he has done everything by the book. “Laret fully complied with UC policy in obtaining approvals,” UCSF spokeswoman Barbara French said in a statement on behalf of Laret, who declined to be interviewed. She said Laret works for the companies on his own time and has no involvement in UCSF purchasing decisions involving Varian and Nuance products.Since Laret joined the Varian board, UCSF has purchased nearly $6.8 million worth of products from the company, UC records show. Yet Varian still identifies Laret as independent, according to SEC documents.Varian spokesman Spencer Sias said the company does so because Laret makes no purchasing decisions for UCSF involving the firm.UCSF’s French said Laret’s corporate board work has “helped him bring private sector financial and management discipline to a very large public sector enterprise.” She cited Laret’s oversight of the UCSF Medical Center at Mission Bay, a $1.5 billion hospital complex that opened in 2015 “on time and under budget.” However, Laret was no stranger to financial and management discipline before he joined the boards. French’s statement noted that UCSF was losing $60 million a year when Laret arrived in 2000, and said that by 2005, “he had turned it into a $70 million gain.” By serving on the boards of Varian and Nuance, Laret has “been able to introduce fellow board members and business leaders to UCSF and UC — many of whom have elected to receive their health care (there) and/or give philanthropically to the university,” the statement said. Varian’s SEC documents say the company has made “charitable donations to UCSF Medical Center and the regents of the University of California in the past.” Sias said the grants

amounted to less than $30,000 for UCSF’s continuing education program for doctors and nurses, and that the company contributes to many similar programs elsewhere.He said Varian would have made the grants regardless of whether Laret was on the board. In the nine years since Laret joined Varian’s board, UC’s five medical centers have spent more than $34 million with the company on such products as radiation oncology supplies, mainframe software and radiosurgery equipment, UC records show. Of that, $26 million came from UCSF and Laret’s former employers, UCLA and UC Irvine. Since Laret joined the Nuance board in 2010, UCSF has spent $907,273 on the company’s products such as voice software, microphones, documentation programs and other equipment. UCSF previously purchased similar software from J.A. Thomas and Associates. Nuance bought J.A. Thomas in 2012.Two other UC medical centers have also done business with Nuance since Laret joined the company’s board: UCLA ($955,670) and UC Irvine ($219,094). “It would be unusual for these (UCSF purchasing) decisions to come to the attention of Laret,” French said in her statement. “The other four UC medical centers make purchase decisions independently.” In April, the state Assembly’s Higher Education Committee held a hearing on “conflicts and abuse” in the outside employment of UC and California State University executives, about a third of university presidents nationwide serve as a director of at least one corporation and supplement their income by an average of $148,000 a year per board.They said moonlighting — preparing for board and committee meetings, going to and from meetings, joining in conference calls — also eats up time. The 43 university presidents who served on boards and were included in their last research study in 2010 spent an average of 12 days a year on meetings for each board they were on. That’s about the same number of eight-hour workdays that Laret told UCSF that he worked last year for Varian (99 hours) and Nuance (97 hours). About half those hours were docked from his vacation time because he took calls or went to meetings during business hours, according to his report on outside work. He reported doing the rest of the work on personal time. State lawmakers and UC officials are making some changes, but it’s not clear what effect they will have. The 2016-17 state budget, approved two months after the Assembly hearing, calls on UC and CSU to specify how outside work “furthers the public mission of the university,” and to hold a public hearing each year to consider executives’ requests to serve on boards. Although CSU has to abide by the new state regulation, UC, an autonomous public university, does not. Yet the proposal under consideration by the regents appears to strengthen UC’s policy, say ethics experts, though it includes no public approval process.

July 18, 2016

New health co specific events to add TauRX PH III data in mild to moderate Alzheimer's disease and frontotemporal dementia at AAIC Jul 27 2016 SNGX results from the Ebola development studies will be presented by Dr. Carly Chisholm and Dr. Theodore Randolph in a poster entitled "Thermostable Lyophilized Ebola Vaccine Formulations" at the 2016 Workshop on Protein Aggregation and Immunogenicity, on Aug 2-4 2016 AAPL The U.S. Supreme Court will hear arguments Oct 11 2016 on whether Samsung owes all its smartphone profits to Apple even though it infringed only iPhone design

patents (Samsung Elecs. Co. v. Apple Inc., U.S., No. 15-777, argument date announced 7/13/16). A $399 million damages award hangs in the balance. Apple's brief on the merits is due July 29. Amicus briefs from design patent advocates are due Aug 5 2016 (source BBERG) TaiMEd Biologics Theratechnologies Ibalizumab PH III data at IDSA for multidrug resistant HIV Oct 26-30 2016 Theratechnologies TaiMEd Biologics Ibalizumab PH III data at IDSA for multidrug resistant HIV Oct 26-30 2016 ABBV GLPG PH I GLPG2222 CF data at NACF Oct 27-29 2016 GLPG ABBV PH I GLPG2222 CF data at NACF Oct 27-29 2016 BMY SBLA for Opdivo in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with priority review; projected FDA action date Nov 11 2016

Health conferences and events Ethics & Regulation in the Digital Age Conference- Seattle Jul 21 2016 Modeling Disease and Dysfunction with iPSC-derived, Induced Neural Progenitor Cells Kristen Brennand, PhD Assistant Professor Departments of Psychiatry and Neuroscience Icahn School of Medicine at Mount Sinai Wenying Pan, PhD Associate Professor Department of Biochemistry and Molecular Medicine UC Davis School of Medicine Thermo Fisher Scientific Modeling Disease and Dysfunction with iPSC-derived, Induced Neural Progenitor Cells 2:30 - 4:00 p.m. Eastern Time Aug 3 2016 Medical Alley The Coverage Conundrum - Why Won't Payers Cover My Device - and What Can We Do About It? 8:00 - 9:30 AM Aug 11 2016 Concierge Medicine Assembly- Atlanta Aug 12-13 2016

2016 Workshop on Protein Aggregation and Immunogenicity- Breckenridge, Colorado on Aug 2-4 2016. Newsmakers in the Biotech Industry Conf – list of presenters thus far: ARGS BLCM BLADE CTIX CLEMENTIA DIPEXIUM FLEX KALA MODERNA NANOBIOTIX NERV PGNX REBIOTIX SPPI SYROS TIGENIX UNUM, X4 Pharmaceuticals NYC Sep 9 2016 Economist: War on Cancer, join Economist thought leaders to discuss how to scale innovation across multiple facets of cancer Sep 28 2016 Retail’s Digital Summit! Dallas, TX Sep 26-28 2016 FDA workshop on the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing and servicing of medical devices performed by third-party entities and original equipment manufacturers. The workshop is scheduled for Oct 27-28, 2016, in Silver Spring, Md., and via webcast World Orphan Drug Congress attendees updated list: Key speakers from GSK RHHBY ALXN SNY/GENZ EURORDIS Cambridge Rare Disease Network Retina International .Findacure ,EMA European Commission, Belgian Federal Government ,NICE New Rare Cancer track with representatives from NVS CLLS AMGN ABBV PPDI who will discuss science, clinical endpoints and reimbursement . New Gene therapy track with representatives from Spark Therapeutics ONCE , DAK-Gesundheit, GSK, Abeona Therapeutics, RegenXBio, Lysogene . New Clinical Trial Symposium is made up of industry experts from RHHBY AALXN GSK PRAH Nov 15-17 2016

BD Boston Co-hosts from BD Boston 2016 included Detlev Biniszkiewicz, Paul Biondi, Iain Dukes, JC Gutierrez-Ramos, Philippe Lopes-Fernandes, Mary Lynne Hedley, Ivana Magovcevic-Liebisch, Mathai Mammen, Blaine McKee, Lonnie Moulder, C. David Nicholson, Roger Pomerantz, Christopher Seaton, H. Martin Seidel, Chris Viehbacher, and Christoph Westpha- Boston Mar 9 2017

My Informal takeover notes with attributions *health in green, tech in purple, energy/basic in blue, retail in maroon, financials in orange, miscellaneous in black Jul 18 2016 NE and ESV article on Seeking Alpha pontificating the merits of a merger .on The topic today is to evaluate if Noble Corp. Plc., and Ensco Plc. Can be considered as "equals" to merge into a new strong financial entity?There are likely to be mergers and acquisitions in the industry in the next 12 months.The important question is basically how the shares of the "new" company will be distributed between the two "old" companies? Jul 18 2016 ESV and NE article on Seeking Alpha pontificating the merits of a merger .on The topic today is to evaluate if Noble Corp. Plc., and Ensco Plc. Can be considered as "equals" to merge into a new strong financial entity?There are likely to be mergers and acquisitions in the industry in the next 12 months.The important question is basically how the shares of the "new" company will be distributed between the two "old" companies?

Jul 17 2016 PG as potential suitor for PRGO on Bidness

Jul 17 2016 Reckitt Benckiser as potential suitor for PRGO on Bidness

Jul 17 2016 PRGO on Bidness as takeover bait for Reckitt Benckiser, PG, JNJ

Jul 17 2016 JNJ as potential suitor for PRGO on Bidness

Jul 16 2016 In regards to the SGNT Sagent-Nichi-Iko FinTech Global Capital’ Goro.Takeda thinks the deal could light a fire under other generics players.“It may be a signal that Japanese generics manufacturers are finally under strong pressure to do something bolder than before “Japanese generic manufacturers are no longer able to enjoy a growing domestic market and need to find sources of growth,either other markets or biosimilars, article in BC.

Jul 16 2016 ZTS mentioned as takeover bait in Life Science Leader July issue

Jul 16 2016 Gold Miners overview article in IBD and experts at Sprott see more deals coming which could be in the 10’s of deals

Mass Life Sciences.com The Massachusetts Life Science Center and Massachusetts General Hospital launch the Massachusetts Center for Alzheimer Therapeutics Science (MassCATS). This new center is a unique collaboration among world - class industry and academic researchers working t o find therapies for Alzheimer's Disease . The new Center will be located at MGH. Industry partners, including AbbVie, Biogen, Janssen Pharmaceuticals, Inc., Merck and Sunovion Pharmaceuticals have committed $1.25 million in Alzheimer’s - Through MassCATS, neuroscientists from MGH, Harvard Medical School, Broad Institute, Whitehead Institute, MIT, Picower Institute for Learning and Memory, Emory University School of Medicine in Atlanta,

and the Rush University Medical Center in Chicago will collectively use industry and academic resources and the expertise of their respective labs to validate and move targets toward an effective therapy for Alzheimer’s.

CRN on MSFT MSFT Says It'll Miss 1 Billion Windows 10 Device Target, Citing Smartphone Issues: Microsoft has backed off an earlier prediction that Windows 10 would be running on 1 billion devices by mid-2017, suggesting that the shrinking of its smartphone business will prevent it from hitting that goal. Nearly a year after hitting the market, Windows 10 is now running on more than 350 million devices, according to Microsoft. And the operating system has managed to fix most of the issues that vexed Windows 8 users, banishing the considerable negativity that surrounded the operating system. Yet after laying off most of the staff from its 2014 acquisition of Nokia, and taking two separate restructuring charges from the $9.4 billion acquisition, Microsoft now has a smartphone business that's much smaller than it was when it made its initial Windows 10 device calculation. That means it's going to take beyond mid-2017, which is when Microsoft's fiscal 2018 starts, to reach the 1 billion device goal. "We're pleased with our progress to date, but due to the focusing of our phone hardware business, it will take longer than [fiscal year 2018] for us to reach our goal of 1 billion monthly active devices," Microsoft said last week in a statement to ZDNet. Partners told CRN they're not surprised to see Microsoft acknowledging it won't hit a target that many in the channel consider to be overly ambitious. Much of the 350 million device figure is likely traceable to the free Windows 10 upgrade Microsoft starting offering last July, which ends July 29. Andrew Kretzer, director of sales and marketing at Bold Data Technology, a Fremont, Calif.-based system builder that works with Microsoft, said he's been skeptical of the software giant's ability to hit its ambitious Windows 10 user goal since it was announced. "We have plenty of customers who are still very reluctant to move off of Windows 7, whether because of stability problems, privacy concerns or a host of other Windows 10 [performance] issues," Kretzer told CRN, adding that he's still having issues with printing while using the operating system. Microsoft's revelation could also show that Microsoft's aggressive efforts to get Windows 7 and Windows 8 users to upgrade aren't having the desired effect. Microsoft has used a variety of controversial tactics to get Windows 7 and Windows 8 users to upgrade. Last year, users complained when Microsoft downloaded files to their Windows 7 and Windows 8 PCs even if they hadn't signed up for the Windows 10 upgrade.

Things that GO HMMM Headlines for subscribers only Government Hits The Wall In Response To Trump, Another Dangerous Movement Appears Italy Rescues Veneto Banca After EU Bailout Plea Fails Brexit: The View From China Brexit Aftershocks: An Inside Look At The EU’s Raging Power Struggle China To Tolerate Weaker Yuan, Wary Of Trade Partners’ Reaction Is China The Next Japan Puerto Rico Faces Record Default: A Look At The Bonds Due Australia Faces Hung Parliament After Turnbull Suffers Stunning. Election Setback Let’s Talk It Over, Says BoJ, As Banks Lead Japanese Bond Revolt

Vancouver Sun on QLTI AEGR (NOVELION)

QLTI Quadrologic Technology is hoping the third time is a charm as they move to close a merger-slash-acquisition of Massachusetts-based Aegerion, a fellow drug developer with established commercial market access.Two previous mergers failed when larger rivals swept in with richer offers, scooping up Auxilium in 2014 and California-based InSite Vision last year. After peaking near 500 employees and stock prices that topped US$75 a share in the early oughts, QLT has seen investor confidence decline steadily over the past 15 years. The stock is currently trading at less than $2.The company now runs in a “semi-virtual” state with 24 employees and a heavy reliance on experienced consultants working to complete development of the company’s one remaining candidate drug — Zuretinol — aimed at victims of inherited retinal disease, according to QLT’s interim CEO Geoff Cox. Zuretinol is an orphan drug with the potential to earn US$200 to US$500 million worldwide, said Cox, who joined the organization when the company’s entire board was replaced in 2012. Orphan drugs treat rare diseases and as such have finite commercial potential.“We believe that this drug has real potential and can make a real difference for these patients, slowing the progress of the disease and maintaining the health of the retina,” he said. The final clinical trials for Zuretinol will begin this summer and the company plans to apply for commercial approval in Canada, Europe and the United States by early 2019.QLT sold the rights to the prostate cancer medication Eligard for US$230 million in 2009 and divested its macular degeneration drug Visudyne to Valeant Pharmaceuticals in 2012 for US$112.5 million, just months after cutting nearly 150 staff. Since then QLT has been searching for a dance partner to provide marketing and commercialization infrastructure.“Because Zuretinol is the only asset of the company, the board’s strategy has been to find another company to merge with,” said Cox. “Because this is an orphan drug, you’ve got to be able to access patients all over the world, not just in Canada or just in the United States, it has to be global to maximize the value of the program. Mary Szela was appointed chief executive officer of Aegerion in January 2016. Previously, Ms. Szela was chief executive officer of Melinta Therapeutics until August 2015, where she led the company's revitalization effort. For Randy Shore's business story on QLT merger. Photo submitted. Mary Szela was appointed Aegerion CEO in January of 2016. Photo submitted / PNG Aegerion recently cut 80 staff in the aftermath of a messy divorce from former CEO Marc Beer, but enjoys cash flow from established commercial drugs and established access to markets for orphan drugs. New CEO Mary Szela, however, had no new drugs in the development pipeline.A new partnership is just what the doctor ordered for both companies. “This is two fairly troubled companies with some very specific needs,” Szela said. “QLT is a small company with no commercial infrastructure or clinical development capability and that is incredibly expensive to build. They needed someone who could commercialize their products globally.”Aegerion had overbuilt its commercialization infrastructure and requires an injection of cash after significant downsizing. The company has two products already in the orphan drug marketplace, Juxtapid for people with extremely high cholesterol and Myalept, for a rare genetic leptin deficiency disorder that affects the patient’s ability to create fat under the skin. “The former leadership believed these drugs were going to be much bigger than they became,” said Szela, a former CEO of Melinta Therapeutics, which specializes in antibiotics for drug-resistant infections. “They built this Taj Mahal infrastructure that wasn’t warranted even if the products were that large.”

The company’s stock has lost more than 95 per cent of its value since 2014 and currently trades at less than US$1.60.“We needed another product to leverage this global infrastructure and repair our cost structure,” she said. “It really is a perfect marriage of two companies, we have what they need and they have what we need.” The cash QLT brings to the marriage will allow Aegerion to maintain its presence in Europe while it waits for Myalept to get regulatory approval.“If we didn’t have QLT, we would have to cut that workforce and then rebuild it again in a year-and-a-half,” said Szela. “We believe the first approval opportunity for (QLT’s) Zuretinol will be in Europe as well, so we can maintain that infrastructure for two products.” The acquisition of Aegerion results in the creation of a new company Novelion with $100 million in cash after a $22 million infusion from a consortium of existing and new investors, including Armistice Capital, Broadfin Capital, Healthcare Value Capital, JW Asset Management, K2 & Associates Investment Management, Sarissa Capital and Tiger Legatus Capital Management. When the deal closes in several months time, QLT investors will own about two-thirds of Novelion, while Aegerion investors will own the remainder. The company headquarters and its drug development program will remain in Vancouver. Sales operations will stay in Massachusetts. By maintaining its headquarters in Canada, Novelion will be able to leverage QLT’s operational and capital losses under Canadian tax laws and benefit from Canada’s better corporate tax rates, according to Cox.

Aids 2016 Pre-conferences kick off the 21st International AIDS Conference (AIDS 2016) AIDS 2016 was off and running this weekend with a schedule of pre-conference activities that played to capacity crowds in advance of the official conference opening today, on Monday, 18 July. Leaders representing the full spectrum of the global AIDS response, from faith communities to sex workers to paediatric advocates, participated in sessions on the cost of stigma, the fight against HIV criminalization, new treat1 3 ment approaches, and a host of other topics addressing nearly every aspect of the global epidemic. LIVING 2016, the 3rd Positive Leadership Summit, brought together people living with HIV (PLWHIV) from around the world to advocate for human rights and access to care and to reject HIV criminalization and stigma. No More Lip Service, Trans Access, Equity and Rights, Now!, the first ever trans pre-conference at an International AIDS Conference, addressed the most pressing issues for transgender people at risk for or living with HIV. Other pre-conference highlights included the fifth annual Towards an HIV Cure Symposium, which featured the latest in HIV cure research and a keynote address from National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci. Highlighted at the Symposium: the new International AIDS Society (IAS) Global Scientific Strategy: Towards an HIV Cure 2016, published this week in the journal Nature Medicine. This all-new cure strategy builds on the first ever HIV cure scientific roadmap issued by IAS in 2012, reviews significant recent advances in HIV cure research, and presents a plan to address the most critical knowledge gaps in the field. Discussion of a new report on investment in cure research by the IAS HIV Cure resource tracking group and AVAC also cheered delegates at the cure confab – it shows that global investment in cure research has more than doubled since 2012.

Also on the pre-conference programme was TB2016, a global gathering focused on strategies to combat tuberculosis, the biggest killer of people living with HIV worldwide. “TB and HIV are partners in crime,” South African Minister of Health Aaron Motsoaledi told the capacity audience. A press conference to draw global attention to the interplay of the TB and HIV epidemics was chaired by incoming IAS President-Elect Linda-Gail Bekker. Eight additional pre-conference sessions rounded out a packed weekend schedule, focusing on such pressing issues as achieving the 90-90-90 goals; giving voice to positive adolescents and to gay and bisexual men affected by HIV; addressing HIV and viral hepatitis co-infection; and many other topics.

BioTechnology News Today Barcelona's cunning plan to be new heart for digital health, biotech Is Barcelona the next Boston of biotech? Given its tech skills, concentration of universities and hospitals, and surge in funding, Barcelona has factors in common with Boston's biotech cluster. With more than €55m ($61m) invested in Catalan startups in the biotech sector over the first half of 2016, commentators are debating whether the new surge of funding is a blip or a trend. "As a scientist, I deal with hypotheses, and one hypothesis circulating right now is that Barcelona is the next big thing. The place to be," says Jordi Naval, the managing director of the Fundació Bosch i Gimpera. As someone running the tech-transfer and innovation office of the University of Barcelona, he is convinced that the Catalan capital could be a new Boston, because it has that same combination of universities, companies, and human resources. "If you're an investor in life sciences, and this applies to other fields, and think of investing in biotech projects, you know that US projects are well-valued but expensive. Yet, in Barcelona, you've got great science and fewer competitors. So, in a certain way, your money is better invested and can have a better return," he tells ZDNet. Recently, at the BizBarcelona congress, Naval, who is a cofounder of several startups in the biotech field, encouraged entrepreneurs to enter the digital-health ecosystem by emphasizing that the scientific publications ratio per researcher in Catalonia stands at 0.62, double the EU average of 0.30 in 2015."It's assumed that if you're good at producing scientific publications, much of this science has to be transferable," he says. The Biocat Report, published recently by the body tasked with promoting the Catalan healthcare and life-sciences sector, suggests he's right. As of September 2015, the region of Catalonia had 499 tech companies in the biotech, medical-technology, and digital-health fields. Alfons Nonell-Canals, CEO of Mind the Byte, a bioinformatics company specializing in computational drug discovery using a pay-per-use software-as-a-service platform, also sees a move to more personalized services. The European Space Agency's Business Incubator Center, located in Barcelona, aims to attract 40 startups by 2018 and foster the space industry ecosystem in the region. His firm's platform, developed with open-source software, enables researchers to predict biological activity and understand why compounds work or how they bond with proteins, thus cutting the cost and time in the various phases of drug development. The company is located at the Barcelona Science Park and Copenhagen Bio Science Park. "We chose Copenhagen to easily expand to Scandinavia and the north of Europe and because it is in the heart of the Danish-Swedish life science cluster Medicon Valley," Nonell-Canals says. But he says Barcelona has huge academic potential, which creates an attractive environment

for biotech companies."We still have few success stories. I would cite ORYZON. We need more investment, but the sector is growing and attracting more money. In addition, institutions, especially at the level of the Generalitat [Catalan government], are actively supporting its development," he adds. Ana Maiques, CEO of Neuroelectrics, a company developing technologies to monitor and stimulate the brain to help patients in need, argues that on top of Barcelona's good universities, there is an entrepreneurial spirit, an excellent healthcare system, and a strong representation by the Spanish pharma and biotech industry."From a startup perspective, it gives us access to excellent hospitals to run clinical trials and, as a member of CataloniaBio association, a lot of industry peers from which to learn from," she says.

Alzheimer's Disease Traumatic brain injury (TBI) with a loss of consciousness (LOC) may be associated with later development of Parkinson's disease but not Alzheimer's disease or incident dementia, according to a study conducted at the Icahn School of Medicine at Mount Sinai and the University of Washington School of Medicine. Metallic molecule offers real-time monitoring of amyloid plaques in patients with Alzheimer's Metallic molecule offers real-time monitoring of amyloid plaques in patients with Alzheimer's . A metallic molecule being studied at Rice University begins to glow when bound to amyloid protein fibrils of the sort implicated in Alzheimer's disease. When triggered with ultraviolet light, the molecule glows much brighter, which enables real-time monitoring of amyloid fibrils as they aggregate in lab experiments. Scientists create new eye technology for detecting Alzheimer's before onset of symptoms Scientists create new eye technology for detecting Alzheimer's before onset of symptoms Review highlights lack of consistent assessment tool to assess driving ability in people with Alzheimer's Review highlights lack of consistent assessment tool to assess driving ability in people with Alzheimer's No single assessment tool is able to consistently determine driving ability in people with Alzheimer's disease and mild cognitive impairment, a St. Michael's Hospital research review has found. 17beta-Estradiol patch may help reduce Alzheimer's disease risk in newly postmenopausal women 17beta-Estradiol patch may help reduce Alzheimer's disease risk in newly postmenopausal women Can estrogen preserve brain function and decrease the risk of Alzheimer's disease when given early in menopause? Newly postmenopausal women who received estrogen via a skin patch had reduced beta-amyloid deposits, the sticky plaques found in the brains of people with Alzheimer's disease, a Mayo Clinic study published this month in the Journal of Alzheimer's Disease foundation

Biowatch News on EVOK EVOK EVK-001 Fails - Is it all over?On Monday, July 18, 2016 Evoke Pharma reported negative results from its Phase III pivotal trial of nasal metoclopramide (EVK-001) to treat gastroparesis in female diabetics. Oral metoclopramide is already approved for treating this condition. Given the strength of the prior Phase II studies using EVK-001, this indeed raises our eyebrows. The PK would suggest otherwise.

Although Evoke Pharma notes that there were interesting anomalies in the data, we’re not expecting the company to easily survive. At best, it will be a battle. Corcept did it, but had other shots on goal. Evoke is a “one-horse” company and this is the obvious risk with this model. We wish the executive team well as they must struggle with some difficult decisions for going forward.

Health news ADXS lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), has been classified as an advanced-therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies (CAT). AGLE provided a regulatory and clinical update for its AEB1102 program. AEB1102, the company’s lead investigational molecule, is a recombinant human enzyme designed to degrade the amino acid arginine and is being developed to treat two extremes of arginine metabolism. “We have developed a clinical program for AEB1102 with three ongoing clinical trials. The momentum for this program continues to build with AEB1102 receiving Fast Track designation from the FDA for hyperargininemia in May and also receiving a positive opinion for Orphan Drug Designation from the European Medicines Agency this month." AEB1102 for the Treatment of Rare Diseases The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Orphan Drug Designation for AEB1102 for the treatment of hyperargininemia in the European Union. Additionally, Aeglea’s Phase 1 open-label, dose escalation study of AEB1102 for the treatment of patients with Arginase I deficiency has been initiated. The single arm study will enroll up to six patients to assess the safety, tolerability and pharmacokinetics of AEB1102. Enrollment is anticipated to be completed in 2016 with topline data expected in H1 of 2017. AGN plc files the de novo application for the Oculeve Intranasal Tear Neurostimulator device with the FDA This handheld stimulator was investigated for temporarily increasing tear production upon activation in patients with dry eye disease due to decreased tear production. Recently Allergan announced that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator each met their effectiveness endpoints. Amplifon acquires two retail chains in Germany, Focus Hören AG and Die Hörmeister GmbH; terms not disclosed Focus Hören AG operates 62 shops evenly spread throughout the German market; while Die Hörmeister GmbH operates 24 shops, primarily located in northern Germany and with a strong presence in the Hamburg area. Both acquisitions, highly value-accretive, were made at usual market conditions for transactions of comparable size. These acquisitions further accelerate the previously communicated network expansion strategy in Germany, increasing by 40% Amplifon’s network in the country from 260 to 365 shops ANIP receives FDA approval of ANDA for nilutamide tablets Trailing twelve-month sales of Nilandron were $23M according to IMS Health. ANI will immediately launch the product. Management comments: We are excited to have secured approval for a first-to-market generic that represents ANI's second entry into the anti-cancer market and leverages our specialized high-potent manufacturing capability at our plant in Baudette, MN Arch Biopartners announced the formation of a clinical and medical advisory board for AB569, the company's bactericidal drug for treating antibiotic resistant infections in lungs and the urinary tract. In this capacity, the advisory board will provide guidance and expertise on obtaining regulatory approvals, human trial design and patient enrolment to enable first-in-human trials for AB569 in patients with chronic lung infections

ARMH SoftBank to buyout ARMH for GBP17/Share in All-Cash Transaction . SoftBank provided assurances to at least double employee headcount in U.K., increase headcount outside U.K. over next five years SoftBank to maintain HQ in Cambridge, England Will maintain senior management team ATRA is discussing with trial design for Phase 3 studies of EBV-CTL therapy with the FDA and; hopes to have agency’s response in next couple of weeks, CEO Isaac Ciechanover said in interview Jul 14y. ATRA plans to start by year’s end pivotal studies of “off the shelf” cellular therapy platform it licenses from Memorial Sloan-Kettering, Epstein-Barr Virus targeted cytotoxic T-lymphocyte (EBV-CTL), in two indications for EBV post-transplant lymphoproliferative disorder (EBV-PTLD): CEO While number of patients that would use therapy for PTLD after organ transplants or bone marrow transplants is small, he sees EBV-CTL as life-saving for these patients and approval in these settings would smooth the road ahead for approvals in other larger indications like nasopharyngeal carcinoma or glioblastoma: EBV-CTL has FDA breakthrough status in EBV-associated lymphoproliferative disease “We are not CARs, we are not TCRs, we do not genetically modify the cells,” Ciechanover said of co’s immunotherapy platform Atara believes its T cell technology can circumvent some safety issues that have plagued CAR T space recently Patients using Atara’s therapy are adopting an immune system of somebody else for a period of time because theirs isn’t working, CEO said; patients aren’t pre-treated, cells only persist as long as target of interest is there There have been no instances of tumor lysis syndrome or cytokine storm in studies of EBV-CTL in PTLD setting Azalea Health, a health IT software firm with a focus on rural practices and mobile tools, has raised $10.5 million in Series B funding in a round led by Kayne Anderson Capital Advisors. Previous investor Intersouth Partners also participated in the round, which brings the company's total funding to $12.5 million. Azalea's software suite includes revenue cycle management tools, an electronic health record, telehealth tools, a patient portal, and a patient-facing mobile app which recently integrated with Apple HealthKit and with Fitbit. Because the company focuses on small-to-medium rural practices, a focus on mobile, which began in 2013, was a logical next step, CEO and cofounder Baha Zeidan to lmsgd MobiHealthNews. "Azalea Health actually started in a rural area, in rural Georgia," he said. "And with our focus on the rural market, one of the challenges is access to specialty care, so we wanted to develop a tool: not as a point solution but as a fully integrated solution within the scheduling of the patient, within the revenue cycle management of the physician office, and within the EHR documentation. So we developed a telehealth component that would help the physician and the patient extend their care and provide specialty care as well."Through a patient-facing app called Azalea M, patients can share data with their provider via HealthKit, message their provider, view lab results and medication lists, pay their bill, and engage in video visits with their provider. There's also a physician-facing version of the app. Azalea's EHR is also fully accessible on both iOS and Android tablets. AZN Phase 3 AURA3 trial of Tagrisso met its primary goal of demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. 2nd-line treatment studied in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy Says objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement vs chemotherapy Analysis of overall survival is ongoing and results will be presented at an upcoming medical meeting

BAYER MON certain Monsanto shareholders want (at least) $130/share from Bayer Handelsblatt Article also mentions that the $1.5B reverse-breakup fee is also seen as too low and raising that could be another angle to the current negotiations In a separate article, Handelsblatt notes that some of the larger Bayer shareholders, notably Henderson (HGG.LN) are calling for an EGM to vote on the proposed acquisition of Monsanto; notes Henderson is still not convinced that the deal will create value BAYER news that TTOO T2 Biosystems is in collaboration with Bayer to advance drug monitoring and biomarker discovery, The companies signed a multi-year agreement to provide T2 Biosystems’ T2 Magnetic Resonance technology platform, or T2MR, for Bayer’s research and development efforts in blood coagulation disorders. This collaboration will develop tools and evaluate assays to help drive drug discovery and biomarker research for select Bayer hemostasis-related programs. The companies have been working together for the last year and recently extended the collaboration to include a number of pre-clinical and early clinical programs. This collaboration will enable T2 Biosystems and Bayer to evaluate the T2MR technology with the hemostasis drug discovery and development efforts at Bayer Bayer investors including Henderson want an extraordinary shareholder meeting to vote on Monsanto acquisition, Handelsblatt reports, citing Henderson letter to Bayer supervisory board. Henderson can’t accept shareholders not given possibility to vote Some investors fear Monsanto acquisition would limit scope for bids for pharma companies: Handelsblatt BCLI says its NurOwn cells were well tolerated and showed signs of benefit in a Phase 2 study of patients with amyotrophic lateral sclerosis. BCLI said higher percentage of NurOwn-treated patients were considered responders vs placebo group at all but one time point studied up to 24 weeks across varying levels of improvement At the “very high threshold of 100% improvement,” meaning patients needed to show improvement or stable disease to be considered a responder, percentage of responders after 8 weeks was 34% in NurOwn group vs 36% in placebo group; after 24 weeks it was 11% in NurOwn group vs zero in placebo group Results suggest dosing should be repeated at 8 to 12 weeks, Massachusetts General Hospital professor Merit Cudkowicz, an investigator for BCLI, said in a statement Patients who responded to NurOwn had significant increase in levels of VEGF and HGF biomarkers; NurOwn-treated group also had significant reduction in inflammatory markers BCLI CEO Chaim Lebovits said in an interview that the study wasn’t powered to show a difference between placebo and treated groups; a future pivotal trial may focus on patients with faster progressing disease, where the therapy showed greater benefit 97.2% of NurOwn group had treatment-related adverse events (AEs) compared with 75% on placebo; co. said pattern of AEs consistent with a “transient reaction” to transplantation Serious AEs occurred in 22% of NurOwn group vs 8.3% on placebo; BCLI says no SAEs were related to study treatment and most, BCLI having conf call Bexion Pharmaceuticals LLC, of Covington, Ky., said the FDA cleared its application to initiate a first-in-human phase I trial with BXQ-350 for the treatment of cancer. The open-label trial will include adult patients with advanced solid tumors including glioma. Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptides (Bicycles®) platform, announced today the appointment of Stephen J. Hoffman, M.D., Ph.D., as Chairman of the Board of Directors. BIIB is also affected by the RHHBY negative GOYA readout. BIIB is Genentech’s anti-CD20 partner, which currently receives a royalty rate of 35 percent to 40 percent on Rituxan and Gazyva sales, marking about $1.3 billion in Cambridge, Mass.-based Biogen’s revenues in

2015, Losing the current DLBCL market to a biosimilar would be “incrementally negative” for Biogen also BIIB the MAA for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the EMA .The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Earlier this year, the European Commission approved BENEPALI® (etanercept), a biosimilar referencing Enbrel®2, and FLIXABI® (infliximab), a biosimilar referencing Remicade®.Humira is approved in the European Union (EU) for use in moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's disease, and moderate to severely active ulcerative colitis.“The submission of SB5 by Samsung Bioepis reflects the joint goal of the partners to take the lead in expanding access to high-quality biologic therapies for those living with chronic inflammatory disorders,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “At an estimated $4Bn a year, Humira is among the EU’s largest single drug expenditures, but access still remains variable in many markets. If SB5 is approved, we will have the potential to make a substantial impact by bridging this access gap for patients while supporting the sustainability of healthcare systems.” BLFS products embedded in Cook MyoSite autologous cell therapy BLFS announced that its media products are embedded into the autologous cell therapy being developed by Pittsburgh-based Cook MyoSite, a subsidiary of the Cook Group, for treatment of female stress urinary incontinence. In an ongoing phase 3 clinical trial, a muscle tissue biopsy is extracted from the patient and shipped to the Cook MyoSite processing lab, where the manufacturing process is completed. The manufactured dose is frozen and shipped back to the clinic, where the cells are thawed and injected back into the patient near the pelvic floor to improve bladder control. BMY FDA accepted sBLA for Opdivo in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with priority review; projected FDA action date is Nov. 11.European Medicines Agency (EMA) validated a type II variation application for the same patient population; validation of the application confirms the submission is complete and begins the EMA’s centralized review process CGIX Selected by H3 Biomedicine to provide Biomarker discovery and testing CGIX will provide comprehensive, biomarker-based patient profiling using technologies such as next generation sequencing (NGS) to provide biomarker-driven insight regarding target engagement and potential response The program will study H3's lead oncology drug candidate H3B-8800 - an oral, potent and selective small molecule modulator of splicing factor 3B subunit 1 (SF3B1) that is being developed by H3 as an anticancer therapeutic agent China Resources named preferred bidder for GenesisCare - Australian Financial Review Sources tell the AFR that the enterprise value of the deal is A$1.7B ($1.29B), and China Resources beat out Bain, Carlyle Group (CG), and Ping An for the deal. The article reminds readers that KKR (KKR) s selling its 45% stake in GenesisCare and that Macquarie Group (MQG.AU) will be using its own balance sheet to take an equity stake in the deal. Citius Pharmaceuticals completed a feasibility study of proposed academic sites for phase III trials of Mino-Lok, its antibiotic lock solution to treat patients with catheter-related bloodstream infections. The phase III program is expected to begin early next year and run for approximately 24 months.

Clinuvel Pharmaceuticals the FDA deems clinical data package satisfactory for submitting NDA for SCENNESSE. The FDA concludes initial review of datasets on SCENESSE in erythropoietic protoporphyria and the datasets are satisfactory for submission of New Drug Application. A Pre-NDA meeting with FDA will be scheduled to discuss timelines and procedure Clinuvel will request rolling review of NDA under Fast Track designation Clinuvel to request Priority Review to shorten review from 10 to 6 months CTIX receives update on first patient enrolled in phase 2 proof-of-concept study of Brilacidin for ulcerative Proctitis Brilacidin is being evaluated in adults with active, mild to moderate UP or UPS present for at least three months prior to screening with disease extending at least five centimeters, but no further than 40 centimeters from the anal verge, as confirmed by sigmoidoscopic examination. Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the company, 'Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment.' While impressed and optimistic about the initial feedback, Cellceutix needs to strongly caution that this is limited feedback from only the first patient in the trial and the initial results may not be durable for the patient or indicative of future outcomes in the study. CTIX receives update on first patient enrolled in phase 2 proof-of-concept study of Brilacidin for ulcerative Proctitis Brilacidin is being evaluated in adults with active, mild to moderate UP or UPS present for at least three months prior to screening with disease extending at least five centimeters, but no further than 40 centimeters from the anal verge, as confirmed by sigmoidoscopic examination. Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the company, 'Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment.' While impressed and optimistic about the initial feedback, Cellceutix needs to strongly caution that this is limited feedback from only the first patient in the trial and the initial results may not be durable for the patient or indicative of future outcomes in the study. CTRV expands scientific advisory board to focus on seeking curative therapy for hepatitis B Announced the expansion of its Scientific Advisory board (SAB) with internationally recognized hepatitis B (HBV) experts that add significant scientific, clinical and industry expertise. Current SAB member Carol L. Brosgart, M.D., has been appointed Chair of the SAB in support of ContraVir's development of a potentially curative therapy for HBV CTXR Citius Pharmaceuticals is trading up over 3% after announcing the completion of its feasibility study of major academic sites to conduct a Ph 3 trial of Mino-Lok for the treatment of catheter-related bloodstream infections. The company expects to begin the Ph 3 trial 1Q 2017. CYNA provided an update on its European clinical plan following meetings with regulatory authorities. agreement with the EMA has been reached on the design, duration and size for the clinical studies as well as the endpoints CYNA plans to initiate a pivotal clinical program evaluating the safety and efficacy of APL- 130277 in PD patients in Q4 of 2016. Current European Clinical Trial an:Expect to conduct an active comparator study with subcutaneous apomorphine Up to 80 patients will be randomized in a 4-week open label crossover study Functional endpoints will be assessed and will include the duration of ON, preference and ease-of-use of APL-130277, the use of patient diaries, and tolerability of APL-130277 The use of

an anti-emetic should be limited during the study Based on current trial timing, the European clinical trial is expected to commence in Q4 of 2016 Dalcor Pharmaceuticals and the Montreal Heart Institute said data showing genotype-dependent effects of dalcetrapib on high-sensitivity C-reactive protein (hs-CRP) from the prospective analysis of a randomized, placebo-controlled phase III trial of 5,243 genotyped patients with acute coronary syndrome were published in Circulation: Cardiovascular Genetics. Individuals with the GG variant showed significant increase in hs-CRP, while patients with AA genetic profile had no significant increase and suggested a trend for a decrease in hs-CRP when treated with dalcetrapib, compared to placebo. Dalcor said cholesterol efflux findings from the dal-Plaque-2 study also supported dalcetrapib’s benefits on atherosclerotic cardiovascular outcomes in patients with the AA genotype at polymorphism rs1967309 of the ADCY9 gene but not the GG genotype group. DEPO the the Patent Trial and Appeal board (PTAB) of the USPTO declined to institute the Inter Partes Review (IPR) petition filed by Rosellini Scientific, LLC with respect to U.S. Patent No. 7,994,364 with respect to all patent claims subject of the petition. The '364 Patent is listed for the company's NUCYNTA (tapentadol) and NUCYNTA ER (tapentadol extended release tablets) products in the FDA's Orange Book. The company notes that an ANDA decision related to this patent is expected by Sep 302016 EARS announces FDA grants fast track designation for Keyzilen (AM-101) in acute peripheral tinnitus following cochlear injury or otitis media in adults Keyzilen (AM-101) is a NMDA receptor antagonist intended for the treatment of acute peripheral (inner ear) tinnitus. The Phase 3 clinical development program includes the TACTT2 and TACTT3 trials Top-line results from the TACTT2 and TACTT3 trials are expected in August 2016 and in Q4 of 2016, respectively. EIGR announces first patient dosed in phase 2 LIBERTY study of Ubenimex in pulmonary arterial hypertension EIGR announced that the first patient was dosed in the Phase 2 LIBERTY study. The LIBERTY study will evaluate the effects of ubenimex added to current standard of care in patients with pulmonary arterial hypertension (PAH). ELOS announces FDA clearance of UltraShape Power ELOS announces the FDA clearance of its non-invasive fat destruction device, UltraShape Power. The FDA clearance is for non-invasive reduction of abdominal circumference via fat cell destruction. EVOK Ph 3 trial of EVK-001 for the treatment of female patients with symptomatic diabetic gastroparesis did not achieve its primary endpoint. ELTP FDA issued CRL for its abuse-deterrent opioid candidate; CRL determined the NDA was not ready for approval in its present form. ELTP will seek to meet with FDA as soon as possible, then set conf. call to discuss future path for SequestOx GSK ViiV Healthcare,the GSK PFE JV, said 48-week data from the Phase 3b ARIA study showed superior efficacy for Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in previously untreated women with HIV. GSK China FDA approved Cervarix to prevent cervical cancer. GSK said Cervarix is the first HPV vaccine approved in China. In early 2017, the company expects to launch the HPV types 16 and 18 vaccine formulated with adjuvant AS04. GSK did not respond to inquiries regarding price. Hyd Pharma Inc. out of Budapest, has been granted ethical approval by the State Institute for Drug Control in Slovakia for a phase II trial of deuterium-depleted water as a treatment for

chronic lymphocytic leukemia. The company plans to enroll patients with asymptomatic CLL in early stage (Binet A) who are at high risk of progression and are treatment naive, allowing investigators to study the effect of deuterium depletion without being influenced by any ongoing conventional therapy. Icagen announced today that the acquisition of Sanofi's ultra high-throughput biology, screening and chemistry capabilities and research facility in Oro Valley, Arizona (located near Tucson, Arizona) is officially complete. The acquisition includes an agreement between Icagen and Sanofi to collaborate in a multi-year services contract for long term discovery services. As part of its growth plans, the deal will enable Icagen to enhance its current expertise as a specialized pharmaceutical services company with leading capabilities in ion channels and transporters. "The acquisition of Sanofi's west coast ultra high throughput screening Biology and Chemistry capabilities complements our scientific expertise enabling us to offer a broad range of integrated drug discovery services in a growing market," says Icagen President and CEO, Richard Cunningham. IPSEN and LXRX the EMA accepts marketing authorization application for Telotristat Etiprate to treat carcinoid syndrome caused by neuroendocrine tumors, in combination with somatostatin analogues In addition to this European submission, Ipsen will pursue a worldwide regulatory plan for marketing authorization submissions in the territories where it operates. JNJ FDA announces approval of PREZISTA (darunavir) for use in pregnant women with HIV LXRX news on IPSEN that the EMA accepts marketing authorization application for Telotristat Etiprate to treat carcinoid syndrome caused by neuroendocrine tumors, in combination with somatostatin analogues In addition to this European submission, Ipsen will pursue a worldwide regulatory plan for marketing authorization submissions in the territories where it operates. MBVX announces initiation of patient enrollment in Phase I trial evaluating MVT-2163 for patients with locally advanced or metastatic (PDAC) or other CA19-9 positive malignancies MBVX announces the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center (MSK) in a Phase I clinical trial evaluating its new generation diagnostic PET imaging agent, MVT-2163 for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. This study follows another investigational Phase I trial recently initiated at MSK utilizing the company's HuMab-5B1 antibody MVT-5873 as a therapeutic product for the treatment of Pancreatic cancer. The diagnostic imaging study will administer MVT-2163 as a PET imaging agent for patients with pancreatic cancer. Management notes it looks forward to announcing interim results from this trial during Q3 of 2016. MDT receives FDA approval for two-level Prestige LP cervical disc procedures MDT announced the FDA's approval of the Prestige LP Cervical Disc for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments of the neck. The Prestige LP Disc is designed to allow motion in the neck at the operated levels, unlike a fusion surgery that does not preserve motion. Medtech SA news that ZBH Zimmer Biomet to agreed to pay at least $132 million to acquire French robot-assisted surgery firm Medtech Zimmer Biomet has already paid €50.00 per share ($55.39) for more than 1.4 million ROSA shares, which is about 58.77% of the Montpellier, France-based company’s stock, to founder & CEO Bertin Nahum, Newfund and other owners. Zimmer Biomet also put up €50.03 ($55.43) for per Medtech’s convertible bonds and €17.17

($19.02) for its warrants, both of which were owned by Ally Bridge Group.Zimmer Biomet said it also agreed to launch and all-cash tender offer for the Medtech shares it doesn’t already own, subject to the approval of France’s anti-trust watchdog, the Autorité des Marchés Financiers.Medtech board members Frank Yu, Fernand Badano and Eric Briole are resigning in connection with the change of control; Nahum is slated to stay on to lead Zimmer Biomet’s robotics program in Montpellier, the company said.Medtech makes the Rosa Brain and Rosa Spine robot-assisted surgery platforms; the Rosa Spine device won 510(k) clearance from the FDA in January. Both platforms also have CE Mark approval in the European Union.“Ally Bridge Group has been a true global partner – and helpful to us particularly in China and the U.S.,” Nahum said in prepared remarks.“ MON certain Monsanto shareholders want (at least) $130/share from Bayer (BAYN.GR) -- Handelsblatt Article also mentions that the $1.5B reverse-breakup fee is also seen as too low and raising that could be another angle to the current negotiations In a separate article, Handelsblatt notes that some of the larger Bayer shareholders, notably Henderson (HGG.LN) are calling for an EGM to vote on the proposed acquisition of Monsanto; notes Henderson is still not convinced that the deal will create value MON news that Bayer investors including Henderson want an extraordinary shareholder meeting to vote on Monsanto acquisition, Handelsblatt reports, citing Henderson letter to Bayer supervisory board. Henderson can’t accept shareholders not given possibility to vote Some investors fear Monsanto acquisition would limit scope for bids for pharma companies: Handelsblatt MRK-KG Cladribine Tablets accepted for review by EMA for the treatment of relapsing-remitting multiple sclerosis. MSFT says It'll Miss 1 Billion Windows 10 Device Target, Citing Smartphone Issues Microsoft has backed off an earlier prediction that Windows 10 would be running on 1 billion devices by mid-2017, suggesting that the shrinking of its smartphone business will prevent it from hitting that goal. Nearly a year after hitting the market, Windows 10 is now running on more than 350 million devices, according to Microsoft. And the operating system has managed to fix most of the issues that vexed Windows 8 users, banishing the considerable negativity that surrounded the operating system. Yet after laying off most of the staff from its 2014 acquisition of Nokia, and taking two separate restructuring charges from the $9.4 billion acquisition, Microsoft now has a smartphone business that's much smaller than it was when it made its initial Windows 10 device calculation. That means it's going to take beyond mid-2017, which is when Microsoft's fiscal 2018 starts, to reach the 1 billion device goal. "We're pleased with our progress to date, but due to the focusing of our phone hardware business, it will take longer than [fiscal year 2018] for us to reach our goal of 1 billion monthly active devices," Microsoft said last week in a statement to ZDNet. NAVB updates litigation with CRG; court orders parties to mediation NTRA Unilab enter licensing agreement for NIPT NTRA and Swiss-based Unilabs, one of Europe's leading providers of clinical laboratory testing and medical diagnostic imaging services, announced a Constellation technology transfer licensing agreement that enables Unilabs to offer Panorama, Natera's non-invasive prenatal test (NIPT). The licensing agreement also includes access to Natera's proprietary protocols, CE-marked (European Conforming) reagents, and algorithms within the Constellation software platform.

Pharming Reports Positive Phase 2 Results for Ruconest in HAE says study of Ruconest for prophylaxis in hereditary angioedema shows significant reduction in attack frequency vs placebo. PFE ViiV Healthcare, the PFE GSK PFE JV, said 48-week data from the Phase 3b ARIA study showed superior efficacy for Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in previously untreated women with HIV. PFE is increasingly seen as not pursuing to split up, at least at the current point in time, Bernstein analyst Tim Anderson wrote in note. PRGO announces FDA final approval and launch of store brand equivalent to Zegerid OTC capsules PRGO announced that the FDA has approved the company's ANDA for omeprazole and sodium bicarbonate capsules, 20Mg/1100Mg Profusa had recent news that they won a $7.5 million grant from the Defense Advanced Research Projects Agency (DARPA) and the U.S. Army Research Office for further development of its tissue integrated biosensor technology, the company said Tuesday. The U.S. military sees value in the technology improving mission efficiency through real-time monitoring of combat soldier health status. "Profusa's vision is to replace a point-in-time chemistry panel that measures multiple bio-markers, such as oxygen, glucose, lactate, urea, and ions with a biosensor that provides a continuous stream of wireless data," Ben Hwang, PhD, Profusa's chairman and CEO, said in a news release. Profusa's biosensors seek to overcome foreign body response by fully integrating within the body's tissue—without any metal device or electronics. The sensors are made of a bioengineered "smart hydrogel" that is similar to contact lens material, forming a porous, tissue-integrating scaffold. When exposed to light, the hydrogel is able to luminesce in proportion to the concentration of a specific chemical—oxygen, glucose, or another biomarker. The biosensors are each only between 2 mm to 5 mm long and 200 to 500 microns in diameter. They are placed under the skin with a specially designed injector. RDY has launched Omeprazole and Sodium bicarbonate capsules, 20Mg/1100Mg and 40Mg/1100Mg, a therapeutic equivalent generic version of ZEGERID (omeprazole/sodium bicarbonate) capsules in the United States market, having been approved by the FDA. REGN the FDA designated orphan treatment status for ebola virus infection. , which has generic name Three Human Igg1 Mabs (Regn3470, Regn3471, And Regn3479) RHHBY GOYA study did not meet its primary endpoint of improvement in progression-free survival with Gazyva plus CHOP chemotherapy versus Rituxan plus CHOP chemotherapy in people with previously untreated diffuse large B-cell lymphoma.Says adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies Samsung Bioepis and BIIB, news that that the MAA for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the EMA .The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Earlier this year, the European Commission approved BENEPALI® (etanercept), a biosimilar referencing Enbrel®2, and FLIXABI® (infliximab), a biosimilar referencing Remicade®.Humira is approved in the European Union (EU) for use in moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active

Crohn's disease, and moderate to severely active ulcerative colitis.“The submission of SB5 by Samsung Bioepis reflects the joint goal of the partners to take the lead in expanding access to high-quality biologic therapies for those living with chronic inflammatory disorders,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “At an estimated $4Bn a year,i Humira is among the EU’s largest single drug expenditures, but access still remains variable in many markets. If SB5 is approved, we will have the potential to make a substantial impact by bridging this access gap for patients while supporting the sustainability of healthcare systems.” Sanochemia Pharmazeutika to cooperate with Newfield Therapeutics, University of Graz in the area of oncology The company announced agreement with Newfield Therapeutics Corp and the University of Graz to cooperate on research and development of antitumor peptides for the treatment of malignant melanoma Savara Pharmaceuticals closed its acquisition of Serendex Pharmaceuticals A/S, of Horsholm, Denmark. The all-stock buyout, includes approval based milestones and brings rare respiratory disease candidates, including Serendex’s Molgradex, an inhaled form of GM-CSF, in phase II/III trials for pulmonary alveolar proteinosis, as well as a preclinical inhaled factor VIIa program. SELB Initiation reports were surveyed and generally favorable concerning Selecta's use of its nanoparticle technology to treat gout through its SEL-212 treatment, an enhanced/safer form of Krystexxa.,Initial results appear to show the company has demonstrated clinical proof to solve the limitations immunogenicity poses in treating certain autoimmune, allergy, and vaccination related diseases. Firms were encouraged by SELB's collaborations with Sanofi to use SVPs to treat food allergies, autoimmune disease, as well as prophylactic and therapeutic vaccines. Notes estimates they anticipate SEL-212 reaching the US market in a range of late 2019-2022 with an average estimate of $343M in annual sales generated within the first 5 years, ranging from $155M-$537M. Serendex Savara Pharmaceuticals closed its acquisition of Serendex Pharmaceuticals A/S, of Horsholm, Denmark. The all-stock buyout, includes approval based milestones and brings rare respiratory disease candidates, including Serendex’s Molgradex, an inhaled form of GM-CSF, in phase II/III trials for pulmonary alveolar proteinosis, as well as a preclinical inhaled factor VIIa program. SNGX announced positive preliminary proof-of-concept results from its collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UH Mānoa) and Hawaii Biotech, Inc. (HBI) to develop a heat stable subunit Ebola vaccine. Results from the Ebola development studies will be presented by Dr. Carly Chisholm and Dr. Theodore Randolph in a poster entitled "Thermostable Lyophilized Ebola Vaccine Formulations" at the 2016 Workshop on Protein Aggregation and Immunogenicity, on August 2-4, 2016 in Breckenridge, Colorado. "We continue to demonstrate the broad applicability of the ThermoVax heat stabilization platform," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "These latest results join other successful endeavors with ricin, anthrax and HPV vaccines. We look forward to expanding the use of this proprietary technology, while continuing to develop ThermoVax using RiVax, our novel subunit ricin vaccine, under an active National Institute of Allergy and Infectious Diseases (NIAID) contract award of up to $24.7M over 6 years." SNN news that SYK subsidiary Mako Surgical won a round in its patent war with Smith & Nephew‘s (:SNN) Blue Belt Technologies last week, after the U.S. Patent Trial & Appeal Board

declared parts of a Blue Belt patent invalid.Mako last year asked the patent trial board for an inter partes review of the patent, no. 6,757,582 covering “Methods and systems to control a shaping tool.” The review board found that Mako proved that 11 of the patent’s claims are unpatentable, but failed to show that another 32 claims are invalid.The ruling hinged on 2 independent claims on which the other disputed claims depended, according to the PTAB’s final decision. SoftBank to buyout ARMH for GBP17/Share in All-Cash Transaction . SoftBank provided assurances to at least double employee headcount in U.K., increase headcount outside U.K. over next five years SoftBank to maintain HQ in Cambridge, England Will maintain senior management team SYK subsidiary Mako Surgical won a round in its patent war with Smith & Nephew‘s (:SNN) Blue Belt Technologies last week, after the U.S. Patent Trial & Appeal Board declared parts of a Blue Belt patent invalid.Mako last year asked the patent trial board for an inter partes review of the patent, no. 6,757,582 covering “Methods and systems to control a shaping tool.” The review board found that Mako proved that 11 of the patent’s claims are unpatentable, but failed to show that another 32 claims are invalid.The ruling hinged on 2 independent claims on which the other disputed claims depended, according to the PTAB’s final decision. TauRx will present data of Phase III trials in mild to moderate Alzheimer's and in patients with behavioral variant frontotemporal dementia, the first Phase III data of a tau-targeting therapy on Jul 27 2016 Tiziana Life Sciences acquired a biobank containing the DNA of residents of Sardinia’s Oligastra province, roughly live to celebrate their 100th birthday, about five times the rate in most developed countries and second only to the Japanese island of Okinawa TTOO T2 Biosystems in collaboration with Bayer to advance drug monitoring and biomarker discovery, The companies signed a multi-year agreement to provide T2 Biosystems’ T2 Magnetic Resonance technology platform, or T2MR, for Bayer’s research and development efforts in blood coagulation disorders. This collaboration will develop tools and evaluate assays to help drive drug discovery and biomarker research for select Bayer hemostasis-related programs. The companies have been working together for the last year and recently extended the collaboration to include a number of pre-clinical and early clinical programs. This collaboration will enable T2 Biosystems and Bayer to evaluate the T2MR technology with the hemostasis drug discovery and development efforts at Bayer VAR has received FDA registration for its Claymount Optica 20 and Optica 40 collimators. Claymount's Optica collimators are used to narrow the focus of X-ray beams in film-based and digital radiography systems for improving image quality and minimizing dose to patients. ViiV Healthcare, GSK PFE JV, said 48-week data from the Phase 3b ARIA study showed superior efficacy for Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in previously untreated women with HIV. VRX the excellent Mizuho analyst Irina Koffler writes that she may cut its 2016 forecast of $6.60-$7.00, Also concerned on Walgreens ASPs, deleveraging through assets sales may be “aspirational,” organic growth may slow further XENT: “We delivered a record quarter, reflecting increasing adoption of PROPEL bolstered by the recent approval of the frontal sinus indication. In addition, our sales force expanded to 98 field staff at quarter end, including 73 territory managers and 25 sales consultants.”

Additionally, the company announced that its chief commercial officer, Chas McKhann, is departing for personal reasons. ZBH Zimmer Biomet to agreed to pay at least $132 million to acquire French robot-assisted surgery firm Medtech Zimmer Biomet has already paid €50.00 per share ($55.39) for more than 1.4 million ROSA shares, which is about 58.77% of the Montpellier, France-based company’s stock, to founder & CEO Bertin Nahum, Newfund and other owners. Zimmer Biomet also put up €50.03 ($55.43) for per Medtech’s convertible bonds and €17.17 ($19.02) for its warrants, both of which were owned by Ally Bridge Group.Zimmer Biomet said it also agreed to launch and all-cash tender offer for the Medtech shares it doesn’t already own, subject to the approval of France’s anti-trust watchdog, the Autorité des Marchés Financiers.Medtech board members Frank Yu, Fernand Badano and Eric Briole are resigning in connection with the change of control; Nahum is slated to stay on to lead Zimmer Biomet’s robotics program in Montpellier, the company said.Medtech makes the Rosa Brain and Rosa Spine robot-assisted surgery platforms; the Rosa Spine device won 510(k) clearance from the FDA in January. Both platforms also have CE Mark approval in the European Union.“Ally Bridge Group has been a true global partner – and helpful to us particularly in China and the U.S.,” Nahum said in prepared remarks.“This acquisition of Medtech by Zimmer Biomet is a powerful validation of the innovative technologies – and an impressive global commercial footprint – of the company under the leadership of its founder and CEO, Bertin Nahum,” added Yu, founder, CEO & CIO of Ally Bridge Group. “We expect Zimmer Biomet’s industry-leading position to enable Medtech’s innovative minimally invasive surgical robots to reach a much greater number of patients suffering from neurological and spine disorders globally.”

Bioworld Vivolux seeks to turn out the lights on ‘sleeping’ cancer cells Vivolux AB is taking another approach: eliminating the stray cells by cutting off their power supply. Hans Rosén, CEO, founded the Stockholm-based company in 2004, in partnership with researchers at Uppsala University and the Karolinska Institute, to develop cancer drugs based on phenotypic models, where the behavior of malignant cells under specific conditions is used to identify new targets and suggest the characteristics of molecules that could act on those targets. Last year, Vivolux moved a second compound, the iron chelator VLX600, into a phase I/II safety and tolerability study in patients with refractory advanced solid tumors of any kind. The small molecule is designed to kill “sleeping” cancer cells in regions of solid tumors that are metabolically compromised due to poor vascularization – areas typically untouched by conventional cancer therapies, according to Rosén. VLX600 is preferentially active against those quiescent cells deep within the tumor. The drug is designed as a lipophilic weak base that allows it to penetrate into the core of spheroid tumors, where its activity leads to reduced mitochondrial respiration and eventual tumor cell death. In May, Vivolux reported that it completed the fourth level of dosing in the ongoing phase I/II study and was expanding patient enrollment to a fifth dose level of 90 mg of VLX600.

Seeking Alpha headlines PFE Can Pfizer Make Headway In A Rare Skin Tumor? Zach Hartman, PhD • PFE • Today, 4:02 PM RIGL Why You Should Own Rigel Pharmaceuticals, Inc. Biotech Beast • RIGL • Today, 4:00 PM

OPK OPKO Health - Do Not Lose Hope Nikolai Evdokimov • CRL, OPK • Today, 3:41 PM BOLD We're Not Audacious On Audentes Therapeutics' IPO Don Dion • BOLD • Today, 3:26 PM JNJ Is Now The Best Time To Buy Johnson & Johnson? Andrew Brady • JNJ • Today, 1:01 PM ITEK Here's Why We Are Avoiding Inotek Pharmaceuticals Lowenthal Capital Partners • AERI, AGN, NVS • Today, 11:44 AM HLF Herbalife: An Exciting Roller Coaster Ride Best Left Alone Cliffside Research • HLF • Today, 11:42 AM GILD Gilead: The Beat Goes On Out of Ignorance • GILD • Today, 11:20 AM CYAD C-Cure: Not For The Faint Of Heart The Scepticist • CYAD • Today, 11:11 AM ILMN Illumina - DNA Sequencing Applications And The Holy GRAIL The Virtuous Cycle • ILMN • Today, 9:42 AM HRTX Heron Therapeutics Has An Upcoming Approval Clinically Sound Investor • HRTX • Today, 6:25 AM HLF Is Herbalife Really Worth $65 A Share? Contrarian Analysis • HLF • Today, 5:31 AM HLF Herbalife: Never Again Rogier van Vlissingen • AEG, AVP, EDUC • Today, 4:26 AM

Bioworld on Israeli firms and microbiome R&D efforts Israeli firms advancing microbiome R&D efforts beyond fecal transplants. It is becoming increasingly clear that the microbiome plays a major role in the pathophysiological processes related to various diseases. Those initiatives were on display during the recent 15th Israel Advanced Technologies Industry (IATI) Biomed conference. Eran Segal, of the Department of Computer Science and Applied Math, and Eran Elinav, of the Department of Immunology, both at the Weizmann Institute of Science in Rehovot, are leading much of the microbiome-related science in Israel today. One firm to benefit from that research Mbcure Ltd., licensed rights to technology from Yeda Research and Development Co. Ltd., the tech transfer arm of the Weizmann Institute, Mbcure is a biopharmaceutical company that is part of the Futurx biotech incubator in Ness Ziona. Futurx is financed by a syndicate of J&J Innovation, Takeda Ventures, Orbimed Israel Partners and the Israel Office of the Chief Scientist. Mbcure is developing new therapeutics for diseases that result from microbiome dysbiosis, using bacteria-specific bacteriophage cocktails. Bacteriophages are viruses that destroy bacteria by invading them. They are effective in low doses, as they replicate within the bacteria. And their amplification is self-limiting since it requires the presence of the target bacteria. For those reasons, and because phage cannot infect human cells, phage-based therapeutics are expected to be nontoxic. Phage drugs can target and suppress specific disease associated bacteria. Most importantly, it is anticipated that target bacteria will be unable to develop resistance to Mbcure’s advanced phage therapy. Phage technology is used in various settings, including the treatment of foods to prevent spoilage. CEO Naomi Zak explained that phages are another tool with which to carry out directed modulation of the

microbiome. Mbcure is preparing for its first study in humans of a dermatological indication and is working toward an IND by the end of the third quarter of 2017 and proof of activity by mid- 2018. Looking ahead, Mbcure is also pursuing several oncological indications and is eying metabolic and autoimmune diseases, as well as infections with antibiotic-resistant bacterial strains. In addition to natural phage, the company is also creating designer phage equipped with robust lytic abilities through synthetic biology approaches. Mbcure’s team includes founders Elinav and another Weizmann Institute professor, Rotem Sorek, a renowned phage expert and Crispr researcher. Mybiotics Pharma Ltd. is another microbiome therapeutics company, and it is at the forefront of the newly emerging field of pharmabiotics. The company is manufacturing (instead of harvesting) fecal microbes and then deploying the live bacteria as a drug. The team is developing a line of those products, or “probiotics version 2.0.” The company’s Mycrobe is a platform to culture single bacteria and multibacterial communities on a specific medium, including bacteria that could not be successfully cultured previously. In a targeted treatment setting, the bacteria are administered to colonize and thrive in the colon. The goal is for the bacteria to compete with the resident pathological population and re-establish a well-balanced, healthy microbiome Taking that concept much further, Mybiotics developed its Superdonor technology, a feces-free FMT product line cultured in vitro as an alternative to donor FMT therapy. CEO David “Didi” Dabush said complete microbiome replacement with an artificial product that closely resembles human feces and subsequent colonization and maintenance in vivo is a technological breakthrough. “The ability, unlike with other probiotic products, to overcome the body’s natural resistance and to colonize the gut with an appropriate, essential manufactured bacterial population represents an important, novel therapeutic alternative for patients with a variety of medical indications,” said Dabush. The first indication for Superdonor will be the treatment of C. diff infections with intent to cure. Subsequently, Mybiotics will focus on antibiotic side-effect reduction and post-antibiotic microbiome restoration and on the treatment of other microbiome-related indications. Mybiotics has completed three successful preclinical experiments with Mycrobe, which demonstrated effective bacterial delivery and colonization. First-in-human trials with Mycrobe in a post-antibiotic treatment setting are scheduled to begin at the end of this year and different studies in C. diff infections are planned for next year. TARGETS, DRUGS AND DIAGNOSTICS Another company working on the microbiome is Hy Laboratories Ltd. (Hylabs), founded in 1974 in Rehovot.

Kaiser Family Foundation Analysis Finds Specialty Drugs Rank High Among Medicaid’s Most Costly Outpatient Drugs Abilify, an antipsychotic used in the treatment of schizophrenia and bipolar disorder, was the most costly drug in state Medicaid programs overall in the new analysis, which examines the 50 most costly drugs to Medicaid before rebates (which bring down the final cost to the program and vary across drugs) between January 2014 and June 2015. The analysis explains that drugs can be costly to the program because each prescription costs a lot or because they are heavily prescribed -- or both. Hepatitis C drugs Sovaldi and Harvoni rank second and fourth in the analysis, mainly because of the high price for a course of treatment. These drugs cure hepatitis C in the vast majority of patients and their use spiked over the period of the analysis following their introduction. With over 70 million beneficiaries, many with complicated health needs, Medicaid is one of the largest providers of prescription drugs in the U.S., spending $27.3 billion on outpatient drugs

(after rebates) in 2014. In addition to Abilify, Sovaldi and Harvoni, the top 5 most costly drugs for Medicaid overall before rebates included Vyvanse, used to treat ADHD, and Truvada, which is used to treat HIV. The most prescribed drug in Medicaid programs was the opioid hydrocodone-acetaminophen, the generic form of the painkiller Vicodin. It ranked 37th in total cost before rebates due to its more modest price compared to other medications on the list.

BioPharma Dive on PDUFA VI FDA released the sixth iteration of the Prescription Drug and User Fee Act (PDUFA), which covers procedures, goals, updates and timelines for the period between 2018 and 2022. The fifth and current iteration of PDUFA expires September 2017. development and review process, as well as more flexibility around clinical trial design. The long-awaited PDUFA guidance will go into effect between the end of 2017 and the beginning of 2018. In addition to expediting the review process, the guidance aims to integrate the patients' voice into the drug development and review process, and to increase the FDA's transparency and rapport with the industry. The new guidelines also address new ways to upgrade the process of dealing with drugs for rare diseases, such as allowing for more flexible clinical trial design and use of biomarkers.

EE times on FCC paves the way for 5G The U.S. Federal Communications Commission (FCC) Thursday (July 14) voted unanimously to approve a set of rules allocating spectrum for 5G wireless broadband communications in the United States.The FCC’s vote makes the U.S. the first country in the world to approve rules for communications operating at frequencies above 24 GHz.“What’s significant about this is that it really shows that the U.S. is in the forefront of 5G,” said Wayne Lam, principal analyst for telecom electronics at market research firm IHS Inc., in an interview with EE Times. The CTIA, a trade group representing the U.S. wireless communications industry that had pushed hard for the FCC to set rules for 5G, welcomed the FCC’s order. "Today's vote by the FCC to make high band spectrum available for 5G was a clear victory for Americans' mobile-first lives,” said CTIA President and CEO Meredith Attwell Baker, in a statement. The FCC’s new rules open up nearly 11 GHz of high-frequency spectrum for mobile and fixed-line wireless broadband in the so-called millimeter wave band. The rules create space for service in the 28 GHz , 37 GHz, and 39 GHz bands, and a new unlicensed band between 64 and 71 GHz.“With today’s order, we are repeating the proven formula that made the United States the world leader in 4G: one, make spectrum available quickly and in sufficient amounts; two, encourage and protect innovation-driving competition; and three, stay out of the way of market-driven, private sector technological development,” said FCC Chairman Tom Wheeler, in a statement. The FCC also adopted a proposal to seek comment on applying the rules to another 18 GHz of spectrum encompassing eight additional high-frequency bands.Millimeter wave signals do not travel as far as signals in other frequency bands and do not penetrate dense objects. Because of this, 5G coverage is expected to be enabled by small cells rather than large towers. While the bulk of 4G wireless networks are built on frequencies from 600 MHz to 3 GHz, 5G will be built on much stratospheric bandwidth frequencies, introducing propagation challenges, Rosenworcel said.

“While these super-high signals carry a significant amount of data, they do not go far,” Rosenworcel said. “But we can turn this limitation into a strength by combining these frequencies with small cells packed close together, densifying networks at lower cost.” The limited propagation of millimeter wave frequencies means that the spectrum allotted by the FCC makes 5G a technology that will do more to enable the Internet of Things than cellular voice calls, according to Lam. In densely populated areas, a proliferation of small cells is likely to offer more robust 5G coverage, but the technology is not likely to be widely available in rural areas, he added. In those areas, smartphones are likely to continue to rely on 4G LTE for data and communications even after the deployment of 5G, which is not expected until about the 2020 timeframe, Lam added.

Policy and Medicine Bipartisan PRICED Act Introduced in Congress Three members of Congress, a bipartisan trio that spans both the House and the Senate, have introduced the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act in the House of Representatives and the Senate on Friday, June 24. The bill points to higher medication prices and if passed, would reduce the data exclusivity period for biologic drugs from twelve years to just seven.The bill, clocking in at a whopping two pages, would amend the Reference Product Exclusivity (RPE) provisions in the Public Health Service Act (PHS Act), striking "12 years" and inserting "7 years" in place. Conforming amendments would be made throughout the Act where necessary. The PRICED Act would apply only with respect to a biological product for which the reference product … is licensed under [PHS Act] on or after" the date of enactment of the PRICED Act. Such a reduction would have a large effect on the biologic industry: it would mean significantly more competition for branded biologic manufacturers from the biosimilar drug makers. The current twelve-year data exclusivity threshold for biologic products was set under a compromise in the Affordable Care Act. Since that time, President Obama has advocated for reducing that period to seven years through budget proposals, in an effort to cut healthcare spending. Industry reaction has overall been very predictable: major trade groups oppose any efforts to shorten the period while generic groups support efforts. The Biotechnology Innovation Organization (BIO) argues that anything less than twelve years of exclusivity would have repercussions, i.e., stifled innovation, reduced drug access, and increased prices of drugs in the long run. They also noted that a "majority of biotechnology companies are small, private start-ups, heavily reliant on venture capital investment" and need the full twelve-year incentive. The Generic Pharmaceutical Association (GPhA), on the other hand, argues that the legislation would "speed patient access to more affordable versions of some of the most expensive medicines" and that "as brand and specialty drug costs rise at a concerning rate, the association looks forward to working with Congress and others to ensure timely access to biosimilar medicines." This bill is introduced in the midst of several other important, and related, discussions and events. The Trans-Pacific Partnership (TPP) currently under negotiations, has caused high-level discussions on the exclusivity period, as some countries have pushed for a shorter exclusivity period under the deal (e.g., Australia only allows for a five-year exclusivity period), which United States negotiators have resisted. This bill also comes shortly after the Supreme Court's invitation to the Solicitor General to file briefs regarding the Sandoz and Amgen petitions for certiorari.

The likelihood that the PRICED Act will make its way through Congress and be signed into law by the end of President Obama's term is pretty low. Even still, the bill is yet another sign of the concern on Capitol Hill over drug prices.

Parkinson’s Disease Study finds no substantial link between gadolinium exposure and parkinsonism In a study appearing in the July 5 issue of JAMA, Blayne Welk, M.D., M.Sc., of Western University, London, Canada, and colleagues conducted a study to assess the association between gadolinium exposure and parkinsonism, a degenerative disorder of the central nervous system characterized by tremor and impaired muscular coordination. Leukemia drug increases brain dopamine, lowers toxic proteins linked to Parkinson's or dementia A small phase I study provides molecular evidence that an FDA-approved drug for leukemia significantly increased brain dopamine and reduced toxic proteins linked to disease progression in patients with Parkinson's disease or dementia with Lewy bodies.

Oncology Times headlines Blueprint Proposes Using Real-World Data to Speed Drug Approvals ASCO 2016: Hematological Malignancies, Novel Drug Development in CLL & HNL Can Patients With Metastatic RCC Safely Defer Systemic Therapy? The Right Timing Leads to a New Weapon in Brain Cancer Research More Than Half of CML Patients in Remission After Stopping Nilotinib New Firstline Treatment for Older Patients With Secondary AML Children With Neuroblastoma Improve With Double Stem Cell Transplant Too Fat or Too Thin Might Be Bad for Lung Surgery Testicular Cancer Survivors May Have Hearing Loss After Cisplatin Therapy Immunotherapy After Chemo May Stop Ovarian Cancer From Coming Back

BBERG The Internal Revenue Service is open to expanding the definition of cash or cash-like assets that count as “business assets” needed to qualify for a tax-free spinoff, an agency official said. The IRS released a proposal (REG-134016-15) last week that defined what types of cash and assets are directly related to operating the business. The rules address a brewing conflict between the government and taxpayers about how much cash and investment assets a spunoff entity can hold. The rules would also not let one corporation contain significantly more cash than the other.

Stat Some cautionary notes about the CRISPR revolution came out of the American Society of Hematology last week in Washington The most contentious point involved the danger of off-target effects, which occur when CRISPR mistakenly alters not the intended target, but a different region of the genome altogether. In theory, that could cause ill effects, including cancer (if, say, CRISPR disabled a tumor-suppressor gene). Many researchers, including those planning clinical trials, are using "in silico methods" — algorithms based on computational biology — to predict which regions of the genome are similar enough to the targeted region to be at risk of getting CRISPR'd by mistake. Unfortunately, "the algorithm misses a fair number of them," said Dr. J. Keith Joung of Massachusetts General Hospital. "They really aren’t very good

at predicting where there will be off-target effects," said Joung, who is a co-founder of Editas Medicine and has financial interests in several additional biotechs. Another reason to worry: No two individuals' genomes are identical. So even if most patients don't have any DNA that could draw CRISPR away from its intended target, some patients most likely do have such sequences, thanks to random mutation. Said Andrew May, chief scientific officer of Caribou, "There is going to have to be some consideration of that." SHPG Dr. Len Valentino, who headed medical affairs for Baxalta and now does the same for Shire’s hematology division, said the combined company is on track to launch its latest drug, a treatment for the rare bleeding disorder von Willebrand disease, in the coming months. But it won't be easy for Shire to stay on top. Biogen will soon spin off its hemophilia business in hopes of boosting its latest treatment, a long-acting therapy to replace proteins that help blood to clot. Bayer recently won approval of a similar agent, and Novo Nordisk is in late-stage trials. Valentino isn't sweating it. There may be "so-called disruptive therapies" on the horizon, he said, but "I don’t know that any of them have the same focus and connection to the patient that we have.” Zika new research shows that the Zika virus has two routes by which it can infect a developing fetus, depending on when during a pregnancy the infection occurs. It also shows an existing drug might be able to limit the damage wreaked by the virus.The new study, by scientists at the University of California at San Francisco and the University of California at Berkeley, suggests that an antibiotic called duramycin seems to be able to block Zika’s ability to latch onto the cells it wants to affect.

Reuters on AET HUM HUM while Wall Street is largely betting that antitrust regulators will stop Humana Inc's (HUM.N) takeover by larger rival Aetna shares of HUM could still fall as much as 18 percent if the deal unravels, investors and analysts say. Shares of Humana and Cigna have traded well below their buyout agreements. Antitrust regulators at the U.S. Department of Justice have concerns over how both deals would affect competition and prices in the healthcare market. Of the two transactions, the Humana deal is still seen as having a higher probability of gaining approval.Equity analyst Ana Gupte at Leerink Partners has forecast a chance of less than 50 percent that the Anthem-Cigna deal will close, but expects that Aetna will receive a green light to buy Humana by the third quarter of this year. Leerink's Gupte has also said Humana stock would trade at $140 to $150 if the Justice Department sues to block the deal, while Marti sees it falling as low as $130 if the acquisition is scrapped entirely. They said the estimated downside represents a view shared among many investors, who expect a decision from the Justice Department sometime this month. The Aetna-Humana deal always seemed more realistic and likely that they can divest certain parts more easily and we still think that's the case," said Oliver Marti, portfolio manager at Columbus Circle Investors' Healthcare Strategies fund. CCI did not own any of the insurer shares as of April 30 according to regulatory filings. Aetna and Humana's overlap is primarily in managing Medicare Advantage health programs for the elderly, a position Aetna hopes to strengthen through the merger.

However, Aetna has outlined plans to sell some Medicare Advantage assets in the transaction where there is regional overlap, and has told the Justice Department it has several willing buyers, Reuters reported last week. Emery, chief investment officer at an investment fund called Tareo Capital, said he is in the camp that still sees a possible deal between Aetna and Humana.If either that transaction or Anthem's purchase of Cigna are blocked, he expects the insurers to boost profit growth through share buybacks, and to seek smaller acquisitions. Tareo holds Cigna shares. "I think the sector still has the ability to consolidate," Emery said.

Economic Calendar on Softbank ARMH deal ARMH Japanese telecommunications giant SoftBank Group Corp (OTC:SFTBY) has agreed to purchase the company for the hefty price of £24.3 billion pound (about $32.2 billion).SoftBank, which has a controlling interest in Sprint as well as a stake in Alibaba, is a massive multinational telecommunications and internet corporation founded more than three decades ago. The Tokyo-based group has active operations spanning from fixed-line telecommunications to e-commerce, and is one of the largest publicly traded organizations in Japan –The proposed deal to snap up ARM will be one SoftBank’s most expensive acquisition since it was founded in 1981. The deal is one of the largest acquisitions in Japanese history, even surpassing SoftBank’s purchase of a 78 percent stake in Sprint Corporation (S) – a $22.2 billion transaction approved by the United States Federal Communications Commission in July 2013. In June last year, SoftBank announced that it was increasing its interest in Finnish gaming company Supercell to 73.2 percent. The company was able to boost its ownership after purchasing an additional 22.7 percent stake from external investors. Supercell is a successful mobile game developer that has made popular names like Clash of Clans.In the same week as the Supercell investment was announced, SoftBank also broke the news that it would invest $1 billion in e-commerce company Coupang – a Korean operation with a similar business model to Amazon’s (:AMZN). SoftBank has also invested massive amounts into mobile taxi applications in Asia, such as GrabTaxi in Southeast Asia, India’s Ola and China’s Didi Dache. While it seems as though SoftBank has been making acquisitions left and right, the global tech giant has yet to gain a major presence in the semiconductor, or microchip manufacturing, space. If the most recently announced acquisition is completed, ARM will make up more than a third of SoftBank’s current total global holdings of $79 billion (reported on July 15). Of all the tech companies listed on the London Stock Exchange (LSE), ARM certainly has the highest market value. SoftBank’s official offer is £17 – in all cash – per share of ARM’s common stock. The bid represents a 43 percent premium to ARM’s closing price of $47.44 on Friday. It is the largest takeover of a British company since the United Kingdom voted to exit the European Union last month. Masayoshi Son, Chairman and CEO of SoftBank, said: “SoftBank intends to invest in ARM, support its management team, accelerate its strategy and allow it to fully realise its potential beyond what is possible as a publicly listed company,” said SoftBank’s Chairman and Chief Executive Officer, Masayoshi Son, in a company statement on the matter. “This is one of the most important acquisitions we have ever made, and I expect ARM to be a key pillar of SoftBank’s growth strategy going forward.” The ARM acquisition will provide SoftBank with a cash generating semiconductor manufacturer that is widely considered the market leader in making processors for mobile phones and tablet computers. The company, which has its headquarters in Cambridge, England, brings in a huge

amount of cash, as its power-saving chip designs are used in virtually every mobile device on Earth. ARM generates a lot of its income via royalty payments. Whenever a mobile device maker uses one of ARM’s patented designs, which are known to be energy-saving and efficient, the company receives a fee for the use of its intellectual property. The company’s processor and graphics technologies are used by Apple, Huawei and Samsung in their in-house developed semiconductors. SoftBank will pay fund its purchase with a combination of cash and loans. Once the deal is completed, SoftBank said that it will maintain ARM’s headquarters in Cambridge, as well as keep its senior management team in tact. ARM did not shop around for other buyers before being approached by SoftBank. According to individuals familiar with the matter, the Japanese company had been considering making an official bid before the Brexit, and the country’s departure from the EU was not a factor in its decision to move forward with the offer. According to UK Chancellor of the Exchequer, Philip Hammond, who commented on the multibillion-dollar acquisition: “Just three weeks after the referendum decision, it shows that Britain has lost none of its allure to international investors.” Apart from gaining a large foothold in the mobile device space, SoftBank’s acquisition of ARM positions the Japanese tech giant to take full advantage of the increasingly popular Internet of Things (IoT) market. interconnectivity of non-phone devices such as televisions, automobiles and homes.The vast network of devices that make up the IoT collect and exchange data, and the blossoming industry is representative of the current “paradigm shift” taking place in modern tech. ARM’s IoT-related technologies are expected to be increasingly important for the English company, as it is currently facing a smartphone slump.

Android Headlines Rumor: Google Developing A Mixed Reality Headset GOOGL Although Google has reportedly scrapped development of a standalone virtual reality (VR) headset, a new report indicates that their VR hardware plans have not halted altogether. While the headset they were working on may have been cancelled, and may not be tied to the same device that is currently under development; an anonymous source reported to Engadget that a headset is still coming. The headset in question will not employ VR exclusively, but will rather use both VR and augmented reality (AR) to create a mixed reality experience. Current virtual reality hardware typically requires the use of an accompanying computer or smartphone, but this device will be a standalone headset, so it won’t require any additional hardware to operate. It will include a built-in display, cameras, and sensors for head tracking. The device will very likely integrate with Daydream, the upcoming virtual reality platform from Google. Reports say that as far as design, Google’s headset will be closer to Microsoft’s Hololens than Oculus Rift. Google’s investment in Magic Leap, a company with various mixed-reality projects in the works, likely has something to do with their plans for the development of this headset.

Dr. Kanak De CERU Top Pick of the Day Cerulean Pharma (CERU) shares rose more than 9% on Friday. CERU has seen significant insider buying in recent months. However, the stock is still remains well below its 52-week high of $5.20. CERU is an oncology-focused company applying its Dynamic Tumor Targeting platform to develop differentiated therapies. Its platform utilizes nanoparticle-drug conjugates (NDCs), which consist of polymers that are covalently linked to

anti-cancer therapeutics or payloads. The company ended the first quarter with more than $60 million in cash on its balance sheet. The company’s end of first quarter cash position accounts for almost 90% of CERU’s market cap. This highlights the fact that CERU remains undervalued. Not surprising then that insiders have been buying actively. SGYP shares fell sharply on Friday even as the company provided an update on its lead product candidate. SGYP’s lead product candidate, plecanatide is currently being reviewed by the FDA as a treatment for chronic idiopathic constipation (CIC). The FDA has set the PDUFA date on January 29th, 2017. The drug is also being evaluated by Synergy in a second indication. The company said that it is continuing patient enrollment in its two current Phase 3 clinical trials evaluating plecanatide in irritable bowel syndrome with constipation (IBS-C). The decision was made after trial monitoring showed a slower enrollment pace and an increase in the number of patients not meeting randomization criteria after the screening period prior to starting treatment. The pullback on Friday was due to the delay in the Phase 3 trial. However, I believe that the pullback offers an excellent opportunity to enter SGYP, which remains significantly undervalued. My fair value for SGYP remains at $13.50.

MIT on Precision Medicine Initiative could take years Despite the early successes, we are many years from realizing a “new era of medicine” the president described in his 2015 State of the Union address—if we can realize it at all. Here are four reasons why: 1. The science is still young Valuable information will come from innovative clinical trials like the National Cancer Institute’s MATCH trial, in which thousands of patients are having their tumors sequenced to find genetic abnormalities for which there are targeted drugs. Data generated from such trials could help researchers determine what other genes may influence whether a drug works or not, says Richard Simon, associate director of the NCI’s division of cancer treatment and diagnosis. President Obama speaks at the White House about his precision medicine initiative. Genetic abnormalities in the human genome can also contribute to the development of disease, including some cancers but also conditions like diabetes and heart disease. But while hundreds of these “variants” have been discovered, much is still unknown about what they mean medically. 2. The market for genetic testing is unproven Getting to the next stage of precision medicine requires comprehensive, reliable genetic tests. Conventional diagnostic tests usually detect one or a small number of things at a time, like a key genomic abnormality. Now some companies are selling sophisticated tests based on advanced sequencing that can detect hundreds of abnormalities at once (see “The Great Cancer Test Experiment”).But due in part to the lack of regulation by the FDA, the commercialization of diagnostic tests based on advanced sequencing has outpaced the underlying science of collecting and analyzing the data. Though high-quality tests are indeed available, many of the products on the market are questionable. Different tests can produce different results from the same DNA sample, says Elizabeth Mansfield, the deputy director of personalized medicine and molecular genetics for the FDA. 3. It’s expensive These advanced sequencing tests can cost thousands of dollars, and the questions about their accuracy and clinical validity make insurance companies hesitant to pay for them. That’s why one company is giving away tumor sequencing tests to 100,000 cancer patients.It’s also

expensive to develop a targeted drug. In addition to developing the drug, the company must also spend resources or partner with another company to develop an accompanying diagnostic test, which must receive regulatory clearance at the same time. That policy may change, but in the meantime it may slow drug development. Ultimately, some companies may decide that pursuing new “blockbuster” drugs for very common diseases is a better financial bet than chasing after a drug that might only work for a small number of people. 4. We need more data—and data sharing Perhaps the biggest impediment to precision medicine is that so few people have gotten their genome, or their tumor’s genome, sequenced. That makes it difficult to find enough people to participate in clinical trials for new precision drugs, and limits the pace of scientific progress. It’s not just genomic information that’s needed. The newly launched Precision Medicine Cohort project will establish a database of a million or more volunteers. In addition to sequencing data and medical records, it will contain information about the patients’ cells, proteins, and metabolites—and even data from mobile health tracking devices.Generating this data isn’t enough, though. Combining it into large, shared databases could help illuminate patterns and connections that couldn’t be seen otherwise.But competition leads academic researchers and businesses to keep this data private, and patients worry that sharing their data could compromise their privacy.

Real Clear Health Monday A Cure for AIDS Is No Longer Unthinkable - Lenny Bernstein, Wash. Post ACA: Big Losses in Indiv. Market Augurs Risky Future - B. Blase et al., MC Despite Opioid Concerns, Seniors Get Rx - Michelle Andrews, KHN Do ADHD Medicines Boost Substance Abuse Risk? - Kathleen Doheny, HD Do We Know Enough About Candidates' Health? - Lauran Neergaard, AP Impact of Policy Changes on Medicaid Hospital Pmts - Kaiser Family Fdn Medicaid Expansion's Impact on Safety Net Hospitals - Georgetown CCF Money, Preferences Push States on Long-Term Care - Jenni Bergal, SL Obama on Obamacare's Flaws - Abelson & Sanger-Katz, Upshot Obamacare's Kindest Critic - New York Times Panic Prompted Obamacare Lawlessness - Doug Badger, The Hill Small Businesses Struggle With Health Care - David Yeghiaian, USA Today Soda Taxes: Gaining Steam or Getting Steamrolled? - Anna Gorman, CHL Strengthening the Marketplace by Covering Young Adults - CMS.gov Taxpayers Paying for Scientific Scaremongering - Andrew Langer, The Hill The Changing Landscape of American Life Expectancy - Brookings Why Assume Healthcare Cost Controls Will Fail? - Merrill Goozner, MHC Women Calling Trump to Report on Their Periods - Rebecca Robbins, Stat