Regulatory Focus™ > News Articles > Regulatory Recon: FDA Delays BioMarin and Intercept Decisions, Amarin Suit Stayed Until Feburary (18

Regulatory Recon: FDA Delays BioMarin and Intercept Decisions, Amarin Suit Stayed Until Feburary (18 December 2015)

Posted 18 December 2015 | By Michael Mezher 

Regulatory Recon: FDA Delays BioMarin and Intercept Decisions, Amarin Suit Stayed Until Feburary (18 December 2015)

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

  • Do drug firm ties affect researchers' reporting of study results? (STAT)
  • Big US pharmacies square off on Daraprim supplies (Reuters)
  • FDA postpones decision on Intercept's lead liver drug (Reuters)
  • Amarin, FDA Off-Label Promotion Suit Stayed Until Feb. (Law360-$)
  • BioMarin says FDA to delay deciding on approval of DMD drug (Reuters)
  • FDA's FY 16 Appropriation (Alliance for a Stronger FDA) (Focus)
  • FDA approves wearable defibrillator for children at risk for sudden cardiac arrest (FDA)

In Focus: International

  • Europe recommends lung cancer drugs from AstraZeneca, Lilly (Reuters)
  • Over 500 UK patients gain early access to new skin cancer treatment (MHRA)
  • Increasing access to reports on adverse reactions to medicines (EMA)
  • UK Nurofen advertisements under scrutiny after claims they are 'misleading' (Pharmaceutical Journal)
  • Samsung's Bet on Biotechnology Is Test for Heir Apparent (WSJ-$)
  • Hong Kong Biosimilar Requirements Kick In Jan. 1 (PharmAsiaNews-$)

US: Pharmaceuticals and Biotechnology

  • December is FDA's Month for Giving and Delaying (Strasburger)
  • Those close-outs the FDA promised? They're a long time in coming (BioWorld-$)
  • Nasal spray flu vaccine safe for kids with egg allergies (Reuters)
  • Monoclonal antibody biosimilars (Nature)
  • PhRMA Disowns Companies Like Valeant and Turing (Policy and Medicine)
  • Prepublish or Perish? Making a Case for Medicine to Take a Cue from Basic Science (CardioBrief)
  • Opioids Rocket Docket (DrugWonks)
  • Enrolling Employees or Clinic Staff: Is it Acceptable? (imarc)
  • Stem Cell Board Sends "Strong, Unambiguous Message"; Approves Bold New Vision for the Future (CIRM)
  • Extended-Release PSE Points Acura At First Tamper-Resistant Formulation NDA (Tan Sheet-$)

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

  • Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa (Press)
  • Stem cell therapy does not provide significant improvement in Crohn's disease (EPR)
  • GeNeuro Announces the Launch of Phase IIb Proof-of-Concept Study with GNbAC1 in Multiple Sclerosis and Servier Equity Investment (Press)
  • Puma Biotechnology Expands Third Cohort in Phase II Trial of PB272 in HER2 Mutation Positive Cancer Patients (Press)
  • Catabasis Pharmaceuticals Completes Enrollment for Part A of the MoveDMDSM Trial, a Phase 1/2 Trial of CAT-1004 for the Treatment of Duchenne Muscular Dystrophy (Press)
  • PURE Bioscience Receives FDA Approval for Use of SDC Antimicrobial as Poultry Processing Aid to Reduce Pathogens, Including Salmonella (Press)

US: Medical Devices

  • VA makes "historic move" for vets who want robotic legs (CBS News)
  • The Science -- Or Lack Of It -- Behind Genetic Tests Offered In The Workplace (Forbes)
  • Beyond Fitbit: The quest to develop medical-grade wearables (Reuters)
  • New ResearchKit app to track concussions in study (MNT)
  • Podcast: Jay Crowley On The State Of UDI (Gray Sheet-$)
  • UDI Expands, Questions Roll In, And Debate Over System Adoption Continues (Gray Sheet-$)
  • Life Spine® Announces FDA Clearance of GRUVE™ Anterior Cervical Plate System (Press)
  • Luminex Corporation Receives FDA Clearance for NxTAG® Respiratory Pathogen Panel (Press)

US: Assorted and Government

  • Sasse drops hold on Califf confirmation (BioCentury-$)
  • Are Manufacturers Willing To Do Outcomes-Based Pricing? Payers Are Skeptical (Pink Sheet-$)
  • FDA proposes tanning bed age restrictions and other important safety measures (FDA)
  • Global HIV, tuberculosis programs flat funded in FY 2016 spending bill, yet again (Center for Global Health Policy)
  • Jurors Prepare To Mull First Philly Pelvic Mesh Case (Law360-$)
  • Florida Supreme Court approves language of medical marijuana proposal (Reuters)
  • FDA must develop plan to label genetically engineered salmon, Congress says (Washington Post)
  • Proposed budget for Alzheimer's research may rise by over 50 percent (Washington Post)
  • Fight against superbugs gets dramatic funding boost under congressional budget plan (Washington Post)

Upcoming Meetings and Events              


  • O Biosimilar, where are thou? (ABPI)
  • Empire Genomics Lands CE Mark for Several Products (GenomeWeb)
  • EU OKs Amgen's Imlygic as first oncolytic immunotherapy (PharmaTimes)
  • WP7-SG3 guideline on "Therapeutic medical devices" is now available (EUnetHTA)
  • Commission Responds To French Concerns Regarding Device Sterilization Standard (SCRIP-$)
  • Merck Provides Update on European Medicines Agency Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir (Press)
  • HiberGene's HG Swift Molecular Diagnostics Platform Cleared in Europe (medGadget)


  • IPA calls for time-bound implementation of Katoch committee report on API (PharmaBiz)



  • Regenerative medicine partnerships get attention of Japanese drugmakers (FiercePharmaAsia)


Other International

  • Female survivor may be cause of Ebola flare-up in Liberia (Reuters)
  • Taiwan sets June 2016 deadline on new packaging, insert rules (FiercePharmaAsia)

General Health and Other Interesting Articles

  • Women still outnumbered in medical leadership by men with mustaches, study finds (Washington Post)
  • Scientists Uncover How Opioids Cause Dangerous Breathing Problems (DD&D)
  • Study: Up to 90 percent of cancers not 'bad luck,' but due to lifestyle choices, environment (Washington Post)
  • Helicopter parenting at doctor's office may do more harm than good (Reuters)
  • Malaysia deforestation liked to human cases of monkey malaria (Reuters)
  • Encouraging online reviews can benefit docs (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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