Regulatory Recon: Sanofi and Verily Team up in $500m Diabetes JV Horizon Buys Raptor for $800m (12 September 2016)

Posted 12 September 2016 | By Michael Mezher 

Regulatory Recon: Sanofi and Verily Team up in $500m Diabetes JV Horizon Buys Raptor for $800m (12 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter

In Focus: US

  • Horizon Pharma Buys Rare-Disease Company Raptor for $800 Million (Bloomberg)
  • Sanofi, Google parent in $500 million diabetes joint venture (Reuters) (WSJ)
  • U.S. Senate committee chair: Mylan's response on EpiPen price hike 'incomplete' (Reuters)
  • Newest superbug found in a Connecticut toddler (Washington Post)
  • FDA weighs crackdown that could shut hundreds of stem cell clinics (STAT)
  • U.S. Justice Department subpoenas Taro over generic drug pricing (Reuters)
  • Teva says aims to launch EpiPen-like device by 2018 in US (Reuters)
  • Pediatric Rare Disease Voucher Program Faces Expiration (Pink Sheet-$)
  • Almost 90% of PMA Applicants Received Major Deficiency Letter on First FDA Review Cycle in 2016 (Focus)
  • 510(k) Third Party Review Program: FDA Offers New Draft Guidanc (Focus)
  • MDSAP Authorities Push for Medical Device Industry Participation (Emergo)
  • FDA Form 483: Theranos Initiated Trials Without IRB Approval (Focus)
  • CRISPR cuts out $90M IPO bid as another gene editing biotech goes public (Fierce)
  • Zika-Funding Deal Nears With Talk of Dropping Planned Parenthood Clause (WSJ)
  • Back from Zika hot zone, 'Mosquito Lady' to Congress: Move it! (STAT)
  • Childhood cancer survivors living longer, cancer-free (Reuters)
  • How Congress Can Make Drug Pricing More Rational (Forbes)
  • How Can A Company Market An Ovarian Cancer Screening Test If The FDA Says Women Shouldn't Use It? (Forbes)
  • Widespread Use Of Prescription Drugs Provides Ample Supply For Abuse (NPR)
  • Trial watch: Impact of genetically supported target selection on R&D productivity (Nature)
  • Investigating investment in biopharmaceutical R&D (Nature)

In Focus: International

  • Eli Lilly, Canada Fight For Fees In NAFTA IP Policy Row (Law360-$)
  • South Korea's comprehensive plan to boost BT sector (BioSpectrum)
  • Procedures, Eligibilities and Goals of EMA's Accelerated Access Efforts Are Taking More Concrete Shape (IPQ)
  • Bioneer Gets Korean Approval for Zika Detection Kit (GenomeWeb)
  • GSK sells anesthetics to Aspen for up to $370 million (Reuters) (PharmaTimes)
  • Bayer ponders $1.1 billion portfolio sale to fund Monsanto acquisition (Pharmafile)
  • Surprise German Decision Boosts Jardiance Pricing Potential (SCRIP-$)
  • Real-World Evidence: Lessons From GSK's Salford Lung Study (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Perrigo Targeted by Activist Starboard With New 4.6% Stake (Bloomberg)
  • Pancreatic Cancer Progress? Maybe (In the Pipeline)
  • Organovo to Test Pre-Clinical Drugs on Bio-Printed Kidney Tissue (Xconomy)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Phase III diabetes readout boosts Lexicon (BioCentury) (Fierce)
  • J&J, Achillion aim for best-in-class with early HCV data (Fierce)
  • AmpliPhi Biosciences' Bacteriophage Cocktail Shown to Prevent C. difficile Biofilm Formation and Reduce Colonization (Press)
  • US/EU orphan status for BI's Ofev in systemic sclerosis (PharmaTimes)
  • MGB Biopharma Granted Qualified Infectious Disease Product (QIPD) Designation by U.S. FDA for the Treatment of Clostridium Difficile-associated Diarrhoea (CDAD) for MGB-BP-3 (Press)
  • US FDA Approves Investigational New Drug (IND) Application for Cantrixil(TM) (TRX-E-002-1) in Ovarian Cancer (Press)
  • Long-term Analysis of All 695 Patients Enrolled in Novocure's Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Superior Progression Free and Overall Survival Seen in the Trial's Interim Analysis (Press)
  • Tobira Therapeutics Announces Initiation of Phase 1 Combination Study of Cenicriviroc and Evogliptin (Press)
  • US FDA Approves Investigational New Drug (IND) Application for Cantrixil(TM) (TRX-E-002-1) in Ovarian Cancer (Press)

US: Medical Devices

  • Inside Theranos: Yikes (In the Pipeline)
  • Novo Nordisk Recalls Hypoglycemia Kit (Medpage) (FDA)
  • NIST partnership focuses on infusion pump security (Fierce)
  • Takeda Launches Wearable Digital Technology Pilot Program to Support Patients and Healthcare Providers with Inflammatory Bowel Disease Management (Press)
  • FDA clears icometrix' MRI quantification software (MassDevice)
  • Obalon Therapeutics reveals PMA for weight-loss balloon with $75m IPO registration (MassDevice)
  • Smith & Nephew touts Pico negative-pressure wound therapy in hip, knee surgeries (MassDevice)
  • More evidence gastric bypass surgery leads to sustained weight loss  (MassDevice)
  • OSSIX® VOLUMAX -- New Collagen Scaffold for GBR and GTR with Improved Volume Maintaining Features -- Receives FDA 510(k) Clearance (Press)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program (FDA)

US: Assorted & Government

  • Pfizer Didn't Disclose Viagra's Melanoma Risks, MDL Says (Law360-$)
  • AstraZeneca And The SEC's Focus On Life Sciences (Law360-$)
  • Dropout by Dartmouth Raises Questions on Health Law Cost-Savings Effort (NYTimes)
  • Perdue v. Wyeth Pharmaceuticals, Inc.: A Triple Knockout on Pre-Emption and Innovator Liability Grounds (National Law Review)
  • Another Make Work Project In New Jersey – Duty To Update Claims (Drug and Device Law)
  • FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Washes; Defers Action on Three Active Ingredients (FDA Law Blog)
  • MEDICAID: Key Policy and Data Considerations for Designing a Per Capita Cap on Federal Funding (GAO)

Upcoming Meetings & Events


  • Drug-resistant gonorrhoea spreads in England (OnMedica)
  • NovaBay Pharmaceuticals' Neutrox® Product Line Receives CE Mark and ISO Certification for the European Union (Press)


  • Asian nations plan fund to better prepare for health emergencies, says WHO (Reuters)
  • China OKs ViewRay's MRIdian radiation therapy device (MassDevice)
  • Thermo Fisher opens new state-of-the-art GMP standard facility in South Korea (Pharmabiz)


  • Glenmark gets USFDA nod for Xylocaine ointment (Economic Times)
  • Operations in two govt drug testing labs in Kerala come to a halt due to lack of samples (Pharmabiz)
  • Medical device majors opine if 'Make in India' gains momentum, it could slash equipment cost by 30-50% (Pharmabiz)
  • Maha FDA cancels license of MT Agarwal Hospital for non-compliance to Drugs Act (Pharmabiz)
  • DoP directs NPPA to re-fix ceiling price of 'Coagulation Factor VIII (Pharmabiz)


  • Class 4 in-house IVDs: using the online application form (TGA)
  • Accu-Chek Connect Diabetes Management app (TGA)
  • Tandem Bipolar Hip System (TGA)


  • For one Zika patient, lingering symptoms and few answers (Reuters)
  • Does Asia Have A Secret Weapon Against Zika? (NPR)
  • Eight pregnant women among 329 infected by Zika in Singapore: government (Reuters)
  • Thailand finds 21 new cases of Zika in Bangkok, including pregnant woman (Reuters)

Other International

  • Unwelcome Surprise: A Disease-Spreading Chigger Turns Up In Chile (NPR)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles