Regulatory Recon: Sanofi, Regeneron Hit with CRL Over Manufacturing Issues German Merck Explores Sale of Biosimilars Business (31 October 2016)

Posted 31 October 2016 | By Michael Mezher 

Regulatory Recon: Sanofi, Regeneron Hit with CRL Over Manufacturing Issues German Merck Explores Sale of Biosimilars Business (31 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed Friday's Recon? Read it here.

In Focus: US

  • Sanofi and Regeneron's expected blockbuster hit with FDA CRL for manufacturing concerns (Fierce) (Pharmafile) (Endpoints) (Press)
  • FDA Officials Share Best Practices For Biosimilar Development (Focus)
  • FDA Report Offers Complicated Picture Of Industry Compliance With Postmarket Requirements (Focus)
  • Drugmakers Turn Cheap Generics Into Expensive Pills (WSJ)
  • St. Jude halts pacemaker implants due to data, battery issues (Reuters) (MassDevice) (MDDI)
  • FDA Approves First PFO Occluder From St. Jude (Focus) (Reuters)
  • The Ethics of Hunting Down 'Patient Zero' (NYTimes)
  • Impella No Better Than IABP in Cardiogenic Shock (CardioBrief)
  • Boy's Cardiac Death Led to Misuse of Genetic Test, Study Says (WSJ)
  • FDA, EMA accept submissions for nusinersen for SMA (BioCentury)
  • Popular measure in California ballot targets drug prices (The BMJ)
  • Third Rock Gets $616M to Grow New Crop of Biotech Startups (Xconomy)
  • Backlash Against Drug Prices Hits Manufacturers and Middlemen (WSJ)
  • Biosimilars: Sandoz Pegfilgrastim Review, Amgen Adalimumab Launch Extended To 2018 (Pink Sheet-$)
  • Research Groups Rally Support for Medical Innovation Bill (Morning Consult) (IHP-$)
  • Combo Product Legislation Could Ride On User Fee Reauthorization If Not Passed In Lame Duck (IHP-$)
  • Teva sets out to delay generic competitor to Copaxone (Pharmafile)
  • Drug prices: Where do we go after the Election? (The Conversation)
  • AstraZeneca's head and neck cancer treatment clinical trials put on hold (Pharmafile)
  • Would You Want To Know The Secrets Hidden In Your Baby's Genes? (NPR)

In Focus: International

  • WHO proposes provisional implementation of biological qualifier (GABI) (Pink Sheet-$)
  • Exclusive - Germany's Merck explores sale of biosimilar drug business: sources (Reuters)
  • Expanded access to quality medicines and vaccines is critical to achieving universal health (WHO/PAHO)
  • Brief: French drugs regulator warns of fake API certificates (Securing Industry)
  • Big pharma will pull out of Britain unless we start paying for new drugs, warns AstraZeneca (The Telegraph)
  • Iran unveils 4 biotechnology medicines, stemming $600m outflow (Tehran Times)
  • Influenza vaccine market to grow to £4.3 billion by 2025 (Pharamfile)
  • After India, European Union to probe Wanbury Pharma for illegal export (Economic Times)
  • Finland joins contest to host European Medicines Agency post Brexit (PharmaLetter-$)
  • Clinigen chief cashes in (Financial Times)

US: Pharmaceuticals & Biotechnology

  • Onboarding New Talent: Post-IPO Turnover Of Biotech Boards (LifeSciVC)
  • How To Successfully Strategize Real World Evidence For Market Access (SCRIP-$)
  • FDA Details Number of Postmarketing Studies Completed (FDANews-$)
  • FDA's New Inspection Protocol Begins to Have Impact (FDANews-$)
  • Recordkeeping Issues Cited in Form 483 for Belcher Pharmaceuticals (FDANews-$)
  • Martin Shkreli: I'm not upset about HIV drug hike; it was 'woefully underpriced' (The Guardian)
  • Adaptimmune, MSD to test multiple myeloma combo (Pharmatimes)
  • Injectable birth control for men holds promise; risks remain (Reuters) (The Guardian)
  • To appease a patient lobby, did the FDA approve a $300,000 drug that doesn't work? (LATimes)
  • Cempra falls on FDA's manufacturing concerns (BioCentury)
  • Exclusive: Abortion by prescription now rivals surgery for U.S. women (Reuters)

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

  • New Bristol-Myers Squibb Research on Opdivo (nivolumab) Monotherapy and in Combination With Yervoy (ipilimumab) at SMR 2016 Congress Reinforces Immuno-Oncology Leadership and Scientific Expertise in Melanoma (Press)
  • FDA OKs stem cell-gene therapy trial for ALS (Drug Delivery)
  • Enrollment Commences In Phase III Clinical Study Of Eisai's BACE Inhibitor E2609 In Early Alzheimer's Disease (Press)
  • Entasis Therapeutics to Present Data at IDWeek on ETX2514SUL, a Novel Drug Targeting Multidrug-Resistant Acinetobacter baumannii Infections (Press)
  • Omeros Requests Fast Track Designation for OMS721 for the Treatment of IgA Nephropathy (Press)
  • Ophthotech Announces the Publication of Fovista® in Combination with Lucentis® Phase 2b Study Results in Ophthalmology®, the Journal of the American Academy of Ophthalmology (Press)
  • Vyome Biosciences Administers First In-human Dose of VB 1953 in U.S. Phase 1 Clinical Study in Patients with Facial Acne Vulgaris (Press)
  • ACADIA Pharmaceuticals Initiates Phase II Study of Pimavanserin in Alzheimer's Disease Agitation (Press)
  • ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib (Press)
  • Merrimack Announces Acceptance for Review of ANDA filed by Actavis for Generic Doxorubicin Hydrochloride Liposome Injection (aka DOXIL®) (Press)

US: Medical Devices

  • Should J&J buy Edwards Lifesciences? (MedCityNews)
  • FDA Extends Comment Period on MDUFA II Draft Recommendations (FDA)
  • Brief Summary of the Technical Electronic Product Radiation Safety Standards Committee Meeting (FDA)
  • Senseonics submits FDA PMA application for Eversense CGM (MassDevice)
  • New Data on Medtronic Evolut(TM) R TAVR System Show Excellent 'Real-World' Outcomes in Global Patient Population (Press)
  • FDA posts another Class I HeartWare HVAD recall (MassDevice) (FDA)
  • FDA Approves TOBA II BTK Pivotal IDE Clinical Study(Press)
  • BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections (Press)
  • Onkos Surgical™ Receives FDA 510(k) Clearance for ELEOS™ Limb Salvage System (Press)

US: Assorted & Government

  • Probably the Best Wisconsin Law Decision We've Ever Seen (Drug and Device Law)
  • The Impact of Obamacare, in Four Maps (NYTimes)
  • Comment Deadline Approaches On Update To The Coordinated Framework For The Regulation Of Biotechnology (National Law Review)

Upcoming Meetings & Events


  • Minutes: Expert Group On Health Systems Performance Assessment (EC)




  • Brazil not expecting another big wave of Zika with onset of summer (Reuters)
  • First Baby in Puerto Rico With Zika-Related Microcephaly Born (NYTimes)
  • Vietnam reports first microcephaly case likely linked to Zika - government agency (Reuters)

General Health & Other Interesting Articles

  • First U.S. soda tax cuts consumption beyond expectations (Reuters)
  • Fatal measles complication more common than thought: U.S. study (Reuters)

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.

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