Regulatory Recon: New Global Pharma Head for GSK; Pharma CEOs Discuss Trump (20 January 2017)

Posted 20 January 2017 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                      

  • Pharma CEOs in Davos put brave face on Trump presidency (Reuters)
  • When a Study Cast Doubt on a Heart Pill, the Drug Company Turned to Tom Price (ProPublica)
  • We’ll be watching: 13 STAT reporters on the big changes coming under President Trump (Stat)
  • FDA Commissioner Califf Stepping Down (Medscape)
  • The Bully Pulpit: Trump Versus Drug Prices (Informa)
  • Politicizing the FDA: What the Trump Win Means for New Pharma Regulations (Focus)
  • Regenerative Advanced Therapy Designation (FDA)
  • OPDP Doubles Enforcement Letters, But is Carefully Picking Its Battles (FDA Law Blog)
  • Republican Governors Warn Lawmakers About Repeal of Affordable Care Act (WSJ-$)
  • Obamacare Replacement May Improve Patient Access, Novartis Says (Bloomberg)
  • Bristol won't seek faster Opdivo/Yervoy lung cancer approval (Reuters) (TheStreet)
  • EpiPen rival to be offered free to many but high price for insurers (Reuters) (Stat’s Pharmalot) (Forbes)
  • U.S. health agency tells Grassley there is no EpiPen deal yet (Reuters) (Grassley)
  • NIH Director Francis Collins to stay in his post for now (Washington Post-$) (SNL) (Nature News)
  • A Conversation on the Future of Medicine (World Economic Forum)
  • Exclusive: Malaria champions unnerved by Trump uncertainty at crucial time (Reuters)
  • Working Together to Reduce the Devastating Effects of Opioid Misuse (FDA)
  • FDA approves Synergy's constipation drug Trulance (PMLive) (Endpoints) (FDA)
  • First High-Sensitivity Troponin Test Cleared by FDA (MedPage Today)
  • Gene-edited animals face US regulatory crackdown (Nature News)

In Focus: International

  • Chutes & Ladders: A new global pharmaceuticals head for GSK (FierceBiotech) (PharmaTimes) (BioPharm International)
  • ABPI responds to NICE/ NHS England consultation on evaluating and funding new medicines (ABPI) (PharmaTimes)
  • Notice – Registration Form for the International Medical Devices Regulators Forum's Open Stakeholder Day (Health Canada) (IMDRF)
  • The Q3C(R6) Step 4 presentation available now on the ICH Website (ICH)
  • AbbVie’s IP strategy having a chilling effect on competition, UK judge (BioPharma-Reporter)
  • FDA and EMA: 2016 By the Numbers (Focus) (BioPharm International)
  • Europe Updates Elemental Impurities Strategy (BioPharm International)
  • EMA Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (Press)
  • EMA Committee for Advanced Therapies (CAT) Agenda for the meeting on 18 – 20 January 2017 (EMA)
  • SME info day on the new clinical trial regulation (EMA) (Agenda)
  • Work plan for the Radiopharmaceutical Drafting Group for 2017 (EMA)

US: Pharmaceuticals and Biotechnology

  • Cytori Buys San Antonio-based Azaya’s Drug Delivery Tech for Stock (Xconomy) (FierceBiotech)
  • Pfenex, Pfizer and Sandoz hail biosimilar interchangeability guidance (BioPharma-Reporter)
  • AbbVie Fires Back At Investors' Suit Over Failed Merger (Law360-$)
  • The Billion-Dollar Bid to Prevent Epidemics (MIT Tech Review)
  • Takeda Commences Cash Tender Offer for All Outstanding Shares of ARIAD Pharmaceuticals (Press) (Endpoints)
  • FDA Declares Drug Product Removed for Safety Reasons (Lachman Consultants)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Reproducibility Project only Partially Able to Validate Findings of Prominent Cancer Studies (BioPharm International)
  • 22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report (Focus)
  • Octimet raises EUR 11.3M in series A (BioCentury)
  • EMA Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (Press)
  • Big data technique predicts 12% of unknown protein structures (C&EN)

Medical Devices

  • Eli Lilly gets FDA clearance for insulin dose calculator app (Mobihealthnews)
  • Advanced Cooling Therapy wins CE Mark for esophageal cooling device (MassDevice)
  • Voice analysis tech could diagnose disease (MIT Tech Review)
  • FDA Form 483 Cites 14 Observations for Zimmer Biomet (Focus)

US: Assorted and Government

  • Medicare Advisers Aim to Trim $26B Drug Program (BNA)
  • Walgreens to Pay $50M To Settle Feds' Kickback Claims (Law360-$)
  • FDA Moves to Limit Carcinogen Content in Smokeless Tobacco (MedPage Today)
  • FDA MAPP on Relocation Program (FDA)
  • 2016 Medical Gas Container Closure Rule Questions and Answers (FDA Guidance)
  • Medicare Part D – Direct and Indirect Remuneration (CMS)

Upcoming Meetings and Events             

Asia                                                                                     

  • Gilead Japan to Switch Sovaldi, Harvoni Bottles to Blister Packs (Pharma Japan)

General Health and Other Interesting Articles

  • FDA Issues New Seafood Advice For Moms-To-Be. Not Everyone Is Thrilled (NPR)
  • France says duck cull mostly over as bird flu stabilizes (Reuters)
  • Highly Drug Resistant TB Often Spreads from Person-to-Person (MedPage Today)
  • Can Behavioral Science Help in Flint? (New Yorker)
  • FDA bans ‘close-hold embargoes’ in response to AHCJ protest (AHJC)

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? Send him an email at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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