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Regulatory Recon: Merck Gambles on Early sBLA for Keytruda Combo FDA Accepts BLA Mylan & Biocon's Proposed Biosimilar Trastuzumab (11 January 2017)

Posted 11 January 2017 | By Michael Mezher 

Regulatory Recon: Merck Gambles on Early sBLA for Keytruda Combo FDA Accepts BLA Mylan & Biocon's Proposed Biosimilar Trastuzumab (11 January 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA's Committees Provide Political Cover (WSJ)
  • What Trump could say on Obamacare today (Politico)
  • 'Take Your Medicine' Is Big Pharma's Best Prescription (WSJ)
  • Aiming to leapfrog rivals, Merck gambles on early sBLA for Keytruda dual therapy (PharmaLetter-$) (Reuters) (Endpoints) (Press)
  • 'Super Bowl' of health care has questions about Trump and drug prices, but no answers (MarketWatch)
  • JPM: Bristol Humbled By Competition, Sanofi's Sarilumab Ready For Review, Justifying Spinraza's Price And More (Pink Sheet-$)
  • A year after scantily clad model scandal, mixer during JPM tries to help women in biotech advance (STAT)
  • Oncobiologics: The most interesting biotech at #JPM17? (MedCityNews)
  • JPM: Regeneron's PCSK9 patent rant, Valeant's sell-offs and more (Fierce)
  • Gilead CEO: Pharma industry needs to be more transparent on drug pricing (CNBC) (Fierce)
  • FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances (Focus)
  • FDA Offers Final Guidance on CGMP Requirements for Combo Products (Focus)
  • FDA warns cancer patients not to use PNC-27 products for treatment (FDA)
  • Trump Team Says It Hasn't Asked RFK, Jr., To Lead Vaccine Review (Forbes) (Medpage)
  • Oncology in 21st Century Cures: Heading Toward a Two-FDA Solution? (Pink Sheet-$)
  • Maryland lawmakers push to rein in drug prices (Baltimore Sun)
  • Lilly and Merck Expand Immuno-Oncology Collaboration (Press)
  • Billionaire John Kapoor Stepping Down As CEO, Chairman Of Opioid Maker Insys (Forbes)
  • Report finds new drugs launch faster, but patents expire sooner (PharmaLetter-$)
  • Endo's Opana ER, Generic Oxymorphone Safety Get US FDA Panel Review (Pink Sheet-$)
  • FDA  Accepts BLA for Mylan and Biocon's Proposed Biosimilar Trastuzumab (Press)

In Focus: International

  • Transition to the new European Medical Device Regulations: Risks for the continuity of care (Emergo)
  • How Valeant Had a Bright Idea but Took It Too Far (NYTimes) (CNBC)
  • Chinese Investors Have Money, Want Biotech and Don't Fear Trump (Bloomberg)
  • Call for comments – European Paediatric Regulation (Paul –Ehrlich-Institut)
  • Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (Focus)
  • Reign In Your Distributors And Reps, Chinese Regulator Cautions (Pink Sheet-$)
  • Tokyo Pharma Chief Naito Prods Govt to Secure Predictability of Pricing System (PharmaJapan)
  • A hungry Takeda continues deal spree with $125M T cell pact, option to buy (Endpoints)
  • Celgene takes option to acquire a Swiss biopharma firm (PharmaLetter-$)
  • Post-Brexit UK Could Be 'Back Of The Queue' For Drug Access, Warns MHRA Chair (Pink Sheet-$)
  • Daiichi pulls out of India with closure of 170-strong R&D plant (Pharmafile) (Fierce)
  • Welsh Gov't launches £80m new treatment fund (PharmaTimes)
  • Franco-Swiss collaboration seeks to move mountains in dermato-oncology (PharmaLetter-$)

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US: Pharmaceuticals & Biotechnology

  • Asked and answered: Yes, vaccines are safe (Today)
  • Global Health Technologies Coalition appoints new director (GHTC)
  • Unexplored opportunities in the druggable human genome (Nature)
  • Vivek Ramaswamy's Plans (In the Pipeline)
  • My Top 10 New Biotechnologies of 2016 (Part I) (Biotechr)
  • Wish List, Predictions for 2017 (Pharmaceutical Manufacturing)
  • Report: Shortage of Manufacturing Sterile Injectables (MDTMag)
  • Heartburn Drugs in Pregnancy Tied to Asthma in Babies (NYTimes)
  • Pfizer wants deals that can pad sales 'now or soon.' And it's not waiting for tax reform (Fierce)
  • Drug Pricing 'Opacity,' Degrees Of Transparency Debated By National Academies Panel (Pink Sheet-$)
  • FDA's Approval of a New Abuse-Deterrent Opioid Raises Questions (Focus)
  • FDA Issues Labeling Guidance for Aspirin, Acetaminophen (Focus)
  • Deceptive curcumin offers cautionary tale for chemists (Nature)
  • University of Pennsylvania Should Rethink Over-Hyped Press Releases (Forbes)
  • 5 Things I Learned about FDA Audits from its Sister in Compliance, the FCC (GxPLifeline)
  • FDA-Patented Invention Earns 2016 Patents for Humanity Award for Impact on Global Public Health (FDAVoice)
  • Perlara signs pacts with Grace Science and Wylder Nation Foundation (C&EN)
  • Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices (CDC)
  • The FDA Fails to Prevent Traveler's Diarrhea (Marginal Revolution)
  • Pharma's plan to combat a bad rep: more ads (STAT) (BuzzFeedNews)
  • Pitt U and Bayer in broad R&D collaboration (Fierce)
  • Celgene on track for $21B-plus by 2020, execs say, as they unveil 2017 guidance (Fierce)
  • Don't get too excited about U.S. corporate tax reform, pharma. It may not all be pretty (Fierce)
  • Novo Nordisk hires Fluor to build giant US diabetes drug API plant (InPharmaTechnologist)
  • Top 20 pharma brands dropped more than $2 billion on national TV ads last year (Fierce)
  • Humira finishes year as strong as it started, grabbing No. 1 TV spender spot for December (Fierce)
  • Pain Drug Developer Adynxx Picks Up $16M for Another Clinical Trial (Xconomy)
  • Yes, Commercial Payers Are Adopting Narrow Retail Pharmacy Networks (Drug Channels)
  • Experts consider 'The Donald' effect and more in 2017 pharma predictions (PharmaLetter-$)
  • Roche acquires ForSight VISION4 (PharmaLetter-$)

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

  • Phase III results offer Amgen hope for possible Sensipar replacement (PharmaLetter-$)
  • Alnylam shrugs off revusiran setback as follow-up heads for Ph III read-out (Fierce)
  • First Patient Randomized in a Phase II Study Evaluating the Safety and Efficacy of Anakinra in the Treatment of Acute Gout (Press)
  • Visterra Doses First Patient in Phase 2a Trial for VIS410, its Monoclonal Antibody in Development for the Treatment of Hospitalized Patients with Influenza A (Press)
  • Halozyme announces Phase 2 study in advanced pancreas cancer meets key endpoints (MNT)

US: Medical Devices

  • New Data Shows MedTech Industry Poised for Greater Investment & Growth with Full Device Tax Repeal (AdvaMed)
  • Claret Medical wins a date with the FDA for Sentinel TAVR device (MassDevice)
  • Hill-Rom to pay $330m for Mortara Instrument (MassDevice)
  • Survey: Medtronic, J&J and Stryker best places for medtech sales rep jobs (MassDevice)
  • Zimmer Biomet lifts on Q4 prelims (MassDevice)
  • DexCom gains on Q4 prelims (MassDevice)
  • Varian Medical details Varex Imaging components spinout (MassDevice)             

US: Assorted & Government

  • E&C Unveils "Health Care Central" Web Portal (E&C)
  • About 11.5 million people signed up for Obamacare plans November 1-December 24 (Reuters)
  • Medicaid's Data Gets an Internet-Era Makeover (NYTimes)
  • Amgen Beats Decade-Old Investor Suit Over Off-Label Scheme (Law360-$)
  • HRSA Issues Final Rule Regarding the 340B Penny Pricing Policy and Manufacturer CMP (FDA Law Blog)
  • Ex-NJ Pharma Execs Admit To Generic Drug Price-Fixing Plot (Law360-$)
  • Medical Causation Experts Pass Daubert Test, But Cannot Opine on Plaintiff's Lack of Capacity to Sign Release (Drug & Device Law)

Upcoming Meetings & Events


  • EC Report on the Implementation of Directive 2010/53/EU on Organ Transplant Safety & Quality (EC)
  • European Commission Grants Marketing Authorization for Gilead's Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection (Press)
  • Diabetes treatment Fiasp approved in Europe (PharmaLetter-$)
  • Marketing authorisations granted in December 2016 (MHRA)
  • Parallel import licences granted in December 2016 (MHRA)
  • Advice to minimise the risk of medication error with Braltus (tiotropium) 10 microgram per delievered dose inhalation powder, hard capsule (HPRA)


  • Sourcing Medical Devices in China: Phase 1 – Supplier Search (Pacific Bridge Medical)
  • Paragon CRT® Contact Lenses Approved by China Food & Drug Administration (Press)


  • Maha FDA to inspect factory premise of Centaur Pharma for WHO-GMP violation (PharmaBiz)


  • Literature review on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens (TGA)


  • U.S. Army's planned Zika vax license to Sanofi raises nonprofit's ire (Fierce)

Other International

  • IPEC-Americas 2016 Accomplishments (IPEC)

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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