Regulatory Recon: Wave of Expensive New Drugs to Hit US & EU, EMA Backs Enbrel Biosimilar (20 November 2015)

Posted 20 November 2015 | By Michael Mezher 

Regulatory Recon: Wave of Expensive New Drugs to Hit US & EU, EMA Backs Enbrel Biosimilar (20 November 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

  • Bayer Files for EU, US Approval for New Contraceptive (Reuters) (Press) (Pharmafile)
  • GNC Holdings Suspends Sale of USPlabs Products (Reuters) (Press)
  • Specialty Drugs now Cost More Than the Median Household Income (Washington Post)
  • Companion Diagnostics? For Cancer Care, We Need Better Ones (Forbes)
  • Dr. Reddy's Sues to Use Purple Pill for Heartburn Generic (Law360-$) (Economic Times)

In Focus: International

  • EU Endorses Copy of Enbrel Arthritis Drug From Samsung, Biogen (Reuters)
  • Bumper Haul of Expensive New Drugs Heads to US and Europe (Reuters)
  • New Case of Ebola Found in Liberia (Reuters)
  • Unregulated Antibiotic Sales May Increase Risk of "Superbugs" (Reuters)
  • How to stop antibiotic resistance? Here's a WHO prescription (The Guardian)
  • Sanofi, AstraZeneca swap compounds in new twist on open drug R&D (Reuters)
  • Beximco becomes first Bangladeshi company to receive an FDA approval (PharmaLetter-$)

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US: Pharmaceuticals and Biotechnology

  • Pharmaceutical Industry and FDA Preparing for ICH M7 Implementation (Gold Sheet-$)
  • Amgen Takes The Pledge To Respect Patient Privacy (CardioBrief) (Amgen)
  • How broad can consent be? (Harvard Bill of Health)
  • BioMarin Duchenne Drug Receives Harsh Review From FDA (The Street)
  • The fight to save children's lives — and reshape the FDA (STAT)
  • Two decades of new drug development for central nervous system disorders (Nature-$)
  • Apple and Google needed to make sense of growing clinical data mass, say experts (Outsourcing-Pharma)

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

  • REMD Biotherapeutics Phase 2 Clinical Study of REMD-477 for Patients with Type 2 Diabetes Now Enrolling (Press)
  • Viagra improves insulin sensitivity in individuals at risk for diabetes (Press) (Study)
  • Angiochem Reports Positive Clinical Data with ANG1005 in Breast Cancer Patients with Leptomeningeal Carcinomatosis (Press)
  • Glaukos Submits IND Application to FDA to Study iDose Travoprost Intraocular Implant in Glaucoma Patients (Press)
  • Spectrum Pharmaceuticals Submits Phase 2 Breast Cancer Protocol to FDA as Part of an Investigational New Drug (IND) Application for Poziotinib (Press)
  • Teva's inhalers meet in Phase III asthma studies (BioCentury)
  • Spring Bank, Gilead to test HBV combo (BioCentury)
  • Nitto's ND-L02-s0201: RNAi Anti-Fibrosis Drug for the Treatment of Liver Fibrosis Granted FDA Fast Track Designation (Press)

US: Medical Devices

  • What is needed to incorporate clinical pharmacogenetic tests into the practice of psychopharmacotherapy? (PubMed)
  • Class 1 Device Recall Inspiration Ventilator System (FDA)
  • Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing (Gray Sheet-$) (MedDeviceOnline)
  • Visaris Americas wins FDA 510(k) for radiology and PACS suite (MassDevice)
  • FDA MDUFA III Performance, By The Numbers (Gray Sheet-$)
  • St. Jude Medical wins FDA approval for Proclaim Elite spinal cord stim device (MassDevice)
  • Nanosubmarines Promise a Fast Drug Delivery Device (IEEE Spectrum)

US: Assorted and Government

  • Tourniquet Use Urged in Public-Safety Push (WSJ-$)
  • Allergan-Pfizer Talks Include Allergan as Possible Buyer (WSJ-$)
  • Exclusive: Pfizer negotiating 2-3 percent Allergan break-up fee – sources (Reuters)
  • Flu hearing turns tense as Congress questions progress on vaccines (STAT)
  • Brand-Name Drugs Can Raise Costs Without Boosting Patient Satisfaction (NPR)
  • Stefanik Leads Freshmen Letter On Medical Device Tax Repeal To Speaker Ryan (MedDevicesOnline) (Letter)
  • Busy Day at FDA: Agency Approves the AquAdvantage Salmon Under Strict Conditions of Confinement, Rejects Two Related Citizen Petitions, and Issues Two Guidances (FDA Law Blog)
  • Rehearing En Banc Granted in The Medicines Company v. Hospira, Inc. (Patent Docs)
  • Incretin Preemption Part II – California Tosses Failure to Warn Claims Too (Drug and Device Law)
  • Here's Why Shkreli Is Going To Have His Hands Full Trying To Save KaloBios (Forbes)

Upcoming Meetings and Events              


  • EU Inspectors to Focus on Integrity of Process Validation Data(Gold Sheet-$)
  • EMA And Drug Makers Debate PRIME, Adaptive Pathways, Alzheimer's - And More (SCRIP-$)
  • NICE Should Look To Swiss HTA, Says Roche CEO (Pink Sheet-$)
  • Trilogue Debriefing Planned For EU Medtech Reforms (SCRIP-$)
  • NICE recommends Xofigo (radium-223) for prostate cancer (EPR)
  • Ukraine Transition To Medtech Conformity Assessment "Is Working"(Clinica-$)
  • Vertex Receives EU Approval for ORKAMBI (lumacaftor/ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Two Copies of the F508del Mutation (Press)
  • Biogen Announces Benepal (Etanercept) is the First Biosimilar of Enbrel to Receive a Positive Opinion from CHMP (Press)
  • ABPI responds to the announcement about the future of the Cancer Drugs Fund (ABPI)
  • ABPI response to the publication of the independent review of the UK Research Councils (ABPI)


  • Health Ministry organises national consultation to signal commitment to implementation of IHR (PharmaBiz)
  • AIIMS to develop cheaper cancer drugs with French Foundation (Economic Times)


  • AdvaMed Signs Strategic Cooperation Agreement In Xining, China (MedDeviceOnline)
  • WuXi & Lilly to Develop Dyslipidemia Drug (PharmPro)


  • Australia: Final report of Review of Medicines and Medical Devices Regulation (PharmaLetter-$)

Other International

  • Future epidemic trials must cut through red tape, says Ebola researcher (In-PharmaTechnologist)
  • Swaziland makes progress in quest to eliminate malaria (AP)
  • North Korea Launches First National TB Survey (Voice of America)

General Health and Other Interesting Articles

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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