Regulatory Recon: Brazil Eyes Biosimilars, FDA Gets Injunction against Laser-Maker and WHO Reports on AMR (8 October 2015)

Posted 08 October 2015 | By Michael Mezher 

Regulatory Recon: Brazil Eyes Biosimilars, FDA Gets Injunction against Laser-Maker and WHO Reports on AMR (8 October 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 Device Manufacturer Permanently Enjoined (DoJ) (FDA)
  • Artemisinin: Worthy of Nobel Prize, but Growing Concerns About Resistance (Harvard Bill of Health)
  • Reducing LDL with PCSK9 Inhibitors — The Clinical Benefit of Lipid Drugs (NEJM)
  • Opinion: CMS Rule Undermines Real Cost Savings For Consumers & Could Cripple Fledgling U.S. Biosimilar Market (Forbes)

In Focus: International

  • Ruling on Merck diabetes drug shows domestic firms not favored in India courts (FiercePharmaAsia)
  • WHO Director-General addresses G7 health ministers meeting on antimicrobial resistance (WHO)
  • Brazil Aims to Make Biosimilars the Foundation of a Biotechnology Sector (Life Sciences Connect)
  • Australian scientists turn skin stem cells into 'mini-kidneys' (FiercePharmaAsia)

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US: Pharmaceuticals and Biotechnology

  • FDA Finalizes Integrated Summary of Effectiveness Guidance (FDA) (Focus)
  • Priority Review Vouchers: FDA Has "Concerns" (RPM Report) (FierceBiotech)
  • Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level (FDA)
  • Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDA)
  • FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration (DrugWonks) (Pink Sheet-$) (Focus)
  • Express Scripts looks to limit drug price increases (CNBC)
  • FDA Clarifies ‘Unexpected’ Adverse Event With Compounded Drugs (FDANews-$)
  • FDA Won't Contraindicate Off-Label Corticosteroid Use (Pink Sheet-$) (NEJM)
  • A U.S. nonprofit says it has a better way to make generic drugs (FiercePharmaAsia)
  • CTTI Releases Recommendations and Tools to Maximize Engagement between Research Sponsors and Patient Groups (FDA Law Blog)
  • Scientists call for urgent trials to judge flu drugs for pandemics (Reuters)
  • U.S. cancer doctors drop pricey drugs with little or no effect (Reuters)

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

  • FDA Grants RUCONEST® (C1 Esterase Inhibitor [Recombinant]) Twelve-Year Reference Product Exclusivity (Press) (European Pharmaceutical Review)
  • Marathon Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for Deflazacort as a Potential Treatment of Duchenne Muscular Dystrophy (Press)
  • FDA Accepts sNDA for expanded use of Kalydeco (Vertex)
  • Marathon Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for Deflazacort as a Potential Treatment of Duchenne Muscular Dystrophy (Press)
  • Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib - a CDK 4 and 6 Inhibitor - in Advanced Breast Cancer (Press) (FierceBiotech)
  • Positive PhIII leaves Neurocrine lining up for an FDA filing for tardive dyskinesia (FierceBiotech)
  • Merck KGaA and Pfizer get their fifth-place immunotherapy on the FDA fast track (FierceBiotech) (PMLive)
  • Results from ZINBRYTA™ (Daclizumab High-Yield Process) Phase 3 DECIDE Study Highlighting Efficacy Compared to Interferon Beta-1a  (Press)
  • Treatment Effects Maintained Over Five Years in Majority of Patients with Relapsing Remitting Multiple Sclerosis who Received Genzyme’s Lemtrada (Press)
  • Nektar Submits Investigational New Drug Application for Solid Tumor Malignancies Treatment (PharmPro)

US: Medical Devices

  • FDA warns epidural needle maker International Medical Development (MassDevice)
  • FDA Proposed Rule on Medical Cribs (FDA) (Federal Register)
  • CMS has 30 people to evaluate 30,000 diagnostic tests, but more FDA oversight is likely (FierceMedicalDevices)
  • Vertera Spine wins FDA nod for porous PEEK fusion device (MassDevice)
  • Insightec wins expanded FDA nod for Exablate device (MassDevice)
  • Hitachi wins FDA 510(k) for Supria CT system (MassDevice)
  • Varian Medical wins FDA 510(k), CE Mark for VitalBeam (MassDevice)
  • Elbit Imaging Ltd. Announces that InSightec Announces that the FDA has Approved Exablate System for Treatment in the USA (Press)
  • Great Basin Submits 510(k) Application to the FDA for Shiga Toxin Direct Test (Press)
  • GenVisc 850 Approved by the FDA for Treatment of Osteoarthritis Knee Pain – Disruptive medical device reducing healthcare cost (Press)

US: Assorted and Government

  • Apotex: Amgen's Biosimilar Lawsuit's A Sham, Predatory (SCRIP-$)
  • Fast-Track Bill Will Include Medical Device Tax Repeal (MedDeviceOnline)
  • J&J Says It's Being Harassed During Mesh MDL Discovery (Law360-$)
  • No Error With Comment k Jury Instruction (Drug and Device Law)
  • TPP Trade Deal Sealed: Did Brand-Name Biopharma Really Lose? (SCRIP-$)
  • Heedless Heeding Presumptions – How New York Law Became a Morass (Drug and Device Law)

Upcoming Meetings and Events              


  • Committee for Orphan Medicinal Products: Chair and Vice-chair re-elected (EMA)
  • Notified Bodies Propose Radical Rethink Of EU Approach To Harmonizing Medtech Standards (SCRIP-$)
  • European Court of Justice rules on Supplementary Protection Certificates (PharmaLetter-$)
  • NICE says ‘yes’ to pembrolizumab for advanced melanoma (European Pharmaceutical Review)


  • Industry recommends setting up centre to develop, validate technology for quality medical devices (PharmaBiz)


  • Australia says no new biologics protections in TPP (BioCentury)

Other International

  • Countries at heart of Ebola outbreak see first virus-free week (Reuters)

General Health and Other Interesting Articles

  • Nurse giving flu shots in New Jersey reused syringes (CBS News)

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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