Regulatory Recon: FDA Panel Calls for Further Study of Bayer Sterility Device (25 September 2015)

Posted 25 September 2015 | By Zachary Brennan 

Regulatory Recon: FDA Panel Calls for Further Study of Bayer Sterility Device (25 September 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

  • Medical Panel Calls for Further Study of Bayer Sterility Device (WSJ-$) (Reuters) (NPR) (AP) (Mass Device)
  • Do FDA's Fast-Track Reviews Skimp on Important Data? (MedPage Today) (Focus) (Vox) (FDANews-$)
  • Startup's Cancer Test for the Healthy May Harm Public, FDA Says (Bloomberg) (Focus) (Gray Sheet-$)
  • Drug Lobbyists Hear HHS Is Preparing Drug-Price Containment Plan (InsideHealthPolicy-$)
  • The 21st Century Cures Act: More Homework To Do (Health Affairs Blog)
  • My Lunch With Shkreli: What We Should Learn From Pharma's Latest Monster (Forbes)
  • Strengthening the Clinical Trial Enterprise for Medical Devices: An FDA/CDRH Strategic Priority Update (FDA) (Gray Sheet-$)
  • A health economist explains the real reason American drugs are expensive (Vox)
  • FDA Denies Without Comment Teva Petition on Generic TREANDA Approval (Federal Register)
  • Safe medicine disposal options (FDA)

In Focus: International

  • EU Medicines Agency recommends approval of Amgen's leukemia drug (Reuters) (EMA)
  • EMA recommends granting a marketing authorisation for Entresto (sacubitril/valsartan) for the treatment of adults with symptomatic chronic heart failure (EMA)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015 (EMA)
  • Extrapolation key issue at European biosimilars conference (GaBI)
  • Unmuddling the debate on drug prices (ABPI) (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Pharma R&D Productivity Shows Signs Of Progress (Pink Sheet-$)
  • Cost-Effectiveness Of Upcoming Diabetes And Asthma Drugs To Get ICER Reviews (Pink Sheet-$)
  • Teva Acquires Gecko Health Innovations (Press)
  • Great expectations of biosimilars being reined in by reality (BioWorld-$)
  • BioPharm Americ Interview with Christopher Viehbacher, Gurnet Point Capita (YouTube)
  • Novartis to make 15 drugs available at $1 a month (PMLive) (FDANews-$)
  • Legal Perspective: Compliance top of the agenda for big pharma (Pharmafile)
  • Shire victorious in US Vyvanse patent battle (PharmaTimes) (PharmaLetter-$)
  • GSK’s OTC Facility Cited for Quality Control, Complaint Failures (FDANews-$)
  • Merck, Pfizer team with Dako for avelumab companion diagnostic (PharmaTimes)
  • New report: Eliminating hepatitis C today could reduce future U.S. health care spending by $115 billion over the next decade (PhRMA)
  • Biotech Stock Mailbag: Rebounding From Hillary's Drug Tweet, Global Blood Weighs on Bluebird (TheStreet)
  • Intarcia nabs GSK castoff Phoundry, beefs up diabetes pipeline (FierceBiotech)
  • Malin plots IPOs for portfolio companies over next 12 months (FierceBiotech)
  • Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance (FDA)
  • Generics Maker Can’t Duck Baxter Suit Over Brevibloc (Law360-$)
  • Why bother cooking the books if no one reads them? (Financial Times)
  • Shutdown Looms: Another FDA Merry-go-round Ride (SCRIP-$)

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

  • Merck KGaA and Pfizer Announce FDA Orphan Drug Designation for Investigational Immunotherapy Avelumab in Merkel Cell Carcinoma (Press)
  • Fibrocell and Intrexon Provide Regulatory Update for FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (Press)
  • AbbVie to Advance Once-Daily ABT-494 to Phase 3 in Rheumatoid Arthritis by Year-End (Press) (Reuters)
  • Seeing is believing: Making clinical trial statistical data from medical product testing easy to understand (Mass Device)

US: Medical Devices

  • Innovative Biotherapies wins $1.6m rare disease grant from FDA (Mass Device)
  • Surgical Robotics Serial Entrepreneur’s Stealth Startup Raises $149M (Xconomy)
  • Another Medtronic Preemption Case Appealed to High Court (Gray Sheet-$)
  • CliniCloud Allows Doctors, Patients To Monitor Vital Signs Through Smartphone Apps (Med Device Online)

US: Assorted and Government

  • Management Standards for Hazardous Waste Pharmaceuticals (Federal Register)
  • Tag-Team Enforcement: After Years of FTC Proceedings, Rhode Island Businessman Pleads Guilty to FDC Act and Tax Violations (FDA Law Blog)

Upcoming Meetings and Events              


  • Dutch medicines agency aims to clarify biosimilars confusion (GaBI)
  • CHMP recommends EU approval for Roche’s combination of Cotellic (cobimetinib) and Zelboraf (vemurafenib) in advanced melanoma (Press) (Reuters)
  • Biogen and Sobi receive positive opinion from CHMP for Elocta(TM) (rFVIIIFc) for the treatment of Haemophilia A (Press)
  • CHMP grants positive opinion for idarucizumab (Press)
  • Amgen Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe (Press)
  • Vertex Receives CHMP Positive Opinions for Orkambi (lumacaftor/ivacaftor) and Kalydeco (ivacaftor) (Press)
  • CHMP recommends granting marketing authorisation for the medicinal product Kolbam (EMA)
  • Janssen’s daratumumab accepted for accelerated CHMP assessment for treatment of European patients with heavily pre-treated multiple myeloma (Press)
  • Celgene’s Vidaza (Azacitidine for Injection) Receives Positive CHMP Opinion as New Treatment for Elderly Patients with Acute Myeloid Leukaemia (Press)
  • Medicines Company Receives CHMP Positive Opinion for IONSYS® to Treat Post-operative Pain in Adult Patients (Press)
  • European CHMP Adopts Positive Opinion for Gilead’s Single Tablet Regimen Genvoya (Press)
  • Aegerion’s Lojuxta Submission To Germany's IQWIG Disappoints (Pink Sheet-$)
  • Lonza paper reveals secrets behind cGMP stem cell production (BioPharma-Reporter)


  • Dengue challenges India's health system (Lancet)

Ebola Outbreak

  • bioMérieux Company, BioFire Defense, Receives Emergency Use Assessment and Listing for FilmArray Ebola Test by WHO (Benzinga)

Other International

  • Singapore Few Steps Away From More Streamlined Change Notification Policy (Clinica-$)
  • Biosimilar production in Malaysia (GaBI)
  • Taiwan OTC drug instructions and packet labeling criticized (Taipei Times)

General Health and Other Interesting Articles

  • Biologists find unexpected role for amyloid-forming protein (MIT News)
  • Vaccine Anxiety Looks Very Different In Poor Countries Vs. In America (NPR)
  • Simulation suits teach medical students empathy (Reuters)
  • Texas Is Making Its Own Execution Drugs, Oklahoma Inmate Alleges (BuzzFeed)
  • Report notes alarming global levels of antibiotic resistance (CIDRAP)
  • D.C. Women To Get Access To Full Year’s Worth Of Contraceptives (Kaiser Health News)
  • Big Data, Genetics, and Re-Identification (Harvard Law Blog)

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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