Regulatory Focus™ > News Articles > Regulatory Recon: US FDA Approves Drugs Faster Than EMA (6 April 2017)

Regulatory Recon: US FDA Approves Drugs Faster Than EMA (6 April 2017)

Posted 06 April 2017 | By Zachary Brennan 

Regulatory Recon: US FDA Approves Drugs Faster Than EMA (6 April 2017)

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

In Focus: US                                          

  • FDA approves more drugs, and faster, than Europe, study says (NEJM) (AP) (MedPage Today) (Endpoints)
  • Senators battle over FDA nominee's financial ties (Focus) (WSJ-$) (NY Times-$) (Pink Sheet-$) (SNL) (Xconomy) (MedPage Today) (BioWorld) (The Hill)
  • Theranos Founder Holmes Owes About $25M to Blood-Testing Startup (WSJ-$)
  • Much criticized Mallinckrodt bows out of PhRMA ahead of some tightened restrictions on membership (Endpoints) (WSJ-$)
  • Just How Much Is a Medical Miracle Worth? (Bloomberg)
  • A Strategy For Lowering Brand Drug Prices: Patent Buyouts And Licensing (Health Affairs)
  • Democrats urge Trump to issue guidelines for overriding patents on pricey drugs (Stat-$)
  • FDA Panel Backs Abuse-Deterrent Immediate-Release Opioid (MedPage Today)
  • FDA warns Pfizer clinical investigator (Focus)
  • The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity (FDA Law Blog)
  • Sandoz Goes for Jugular in Its Final Supreme Court Biosimilar Brief (Bloomberg)
  • GOP Has No Choice But To Keep Pushing Health Care Rock Up The Hill (Kaiser Health News)
  • How the GOP Could Use Science’s Reform Movement Against It (The Atlantic)

In Focus: International

  • Abbott Pulls Troubled Absorb Stent From European Market (CardioBrief)
  • Boehringer Ingelheim calls for "strong and united" Europe (PMLive)
  • EU Parliament Adopts New Medical Device, IVD Regulations (Focus) (GenomeWeb-$) (Medical Devices Legal) (COCIR) (Euractiv) (Press)
  • The landscape of the medical technology and biopharmaceutical sectors in the UK (Government Report)
  • UK life science competitiveness indicators (Government report)
  • EU’s biotech potential hindered by investment fears (Euractiv)
  • Ebola: New Trial Launched in West Africa to Evaluate Three Vaccination Strategies (NIH)
  • How Diabetes Got To Be The No. 1 Killer In Mexico (NPR)
  • Trump Cuts Off Funding for U.N. Agency That Supports Contraception (NY Times-$)
  • India Health Ministry may soon house NPPA, Dept. of Pharmaceuticals (Economic Times)

Pharmaceuticals and Biotechnology

  • J&J ordered to pay $5m over false marketing claims (Pharmafile)
  • Google's parent company is vacuuming up top talent in health care and biotech (CNBC)
  • PhRMA Launches New “Share the Savings” Campaign to Urge Payers to Share Negotiated Discounts with Patients (PhRMA)
  • David Meeker, longtime head of Sanofi Genzyme, to leave company after 23 years (Boston Business Journal)
  • Ironwood Pharmaceuticals Appoints Dr. Christopher Wright as Senior Vice President of Global Development and Chief Development Officer (Press)
  • Sartorius buys its PAT and QbD software partner for $72.5m (BioPharma-Reporter)
  • For Walgreens, Narrow Network PBM Partnering Pays Off (Drug Channels)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Allergan’s Botox misses the bullseye in PhII depression study, but researchers confident they can hit it in a major PhIII (Endpoints)
  • Zavante Plans FDA Filing After Antibiotic Hits Clinical Trial Goals (Xconomy) (Endpoints)
  • Novartis Keeps 'JULIET' Study Results Close as Investors and Rival Kite Pharma Wait (TheStreet)
  • How Flawed Science Is Undermining Good Medicine (NPR)
  • She’s hellbent on solving the organ shortage with ‘designer pigs.’ And that’s just the start (Stat)
  • AACR – Long-term melanoma data open another Opdivo weak spot (EP Vantage)
  • CRISPR studies muddy results of older gene research (Nature)
  • Experts want special clinics to prescribe ketamine as antidepressant (Reuters)
  • UK Catapult: QbD and process automation keys for making commercial cell therapies (BioPharma-Reporter)
  • Regeneron Announces Evinacumab has Received FDA Breakthrough Therapy Designation for Homozygous Familial Hypercholesterolemia (Press) (Endpoints)

Medical Devices

  • Making better contact lenses (C&EN)
  • March 2017 PMA approval list (FDA)
  • Cardinal Health closes in on $6B deal for Medtronic’s medical supplies biz (Mass Device)
  • BD Receives FDA 510(k) Clearance for New Flow Cytometer System with Leucocount Reagent Assay (Press)
  • Bausch + Lomb Receives 510(k) Clearance From FDA For Stellaris Elite Next-Generation Phacoemulsification Platform (Press)
  • Medtronic, Washington U land $3m NIH grant for brain-function mapping dev (Mass Device)
  • Alere Presses Del. Court For Access To Abbott Atty Docs (Law360-$)
  • With same training, insulin pumps no better than injections (Reuters)

US: Assorted and Government

  • OGD approvals look about the same (Lachman Consulting)
  • FDA Hits Otsuka Facility for Cleaning, Equipment Maintenance Problems (FDANews-$)
  • FDA’s enforcement actions are putting the global pharmaceutical supply chain at risk (PharmaCompass)
  • FDA Recognizes DUNS Number as Acceptable Identifier for Importers (National Law Review)

Upcoming Meetings and Events               


  • Japan scientists call for boycott of military research (Nature)
  • China FDA accepts JHL trial application for rituximab biosimilar (Big Molecule Watch)
  • India needs to make it mandatory for drug firms to have pharmacovigilance audit for patient safety & GPvP: Moin Don (PharmaBiz)
  • Medicine Shortages Information Initiative (TGA)
  • Data management and data integrity (TGA)

General Health and Other Interesting Articles

  • Walgreens CEO Says Rite Aid Deal Closing Soon (WSJ-$)

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.

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