Regulatory Recon: FDA Expands Indication for Opdivo and Anthrax Vaccine, Entresto Approved in EU (24 November 2015)

Posted 24 November 2015 | By Michael Mezher 

Regulatory Recon: FDA Expands Indication for Opdivo and Anthrax Vaccine, Entresto Approved in EU (24 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

  • FDA approves expanded use of Emergent BioSolution's anthrax vaccine (Reuters) (FDA)
  • FDA approves Opdivo to treat advanced form of kidney cancer (FDA) (Reuters) (SCRIP-$) (Press)
  • Safeway brushes off Theranos, enlists local lab for DTC testing in Arizona (MedCityNews)
  • Expensive new Hep C drugs may be cost-effective even for early disease (Reuters) (JAMA, JAMA Commentary)
  • CVS chooses Amgen's new cholesterol drug over competitor (Reuters) (CardioBrief) (SCRIP-$)
  • Drug makers and insurers, longtime rivals, eye an alliance on prices (STAT)
  • The Pfizer–Allergan Merger Is a Disgrace (The New Yorker)

In Focus: International

  • CFDA implements new drug approval policies (BioCentury) (PharmaLetter-$)
  • Bristol-Myers signs deal with U.N. group for generic hepatitis C drug (Reuters) (Medicines Patent Pool)
  • Almost 16 million on HIV treatment as AIDS pandemic tide turns (Reuters)
  • Novartis heart failure medicine Entresto wins EU approval (Reuters)
  • Scientists create mosquito strain with malaria-blocking genes (Reuters)
  • Botswana receives mobile compact lab to detect counterfeit medicines (Manufacturing Chemist)
  • Malaysian Regulators Issue Updated Conformity Assessment Guidance (Emergo) (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • Success with Cell, Gene Therapies will Rely on Manufacturers, Payers (Thomson Reuters)
  • PDUFA VI Reauthorization: Industry, FDA Discuss Broader Use of Real World Evidence (Focus)
  • API sourcing leads US Gov to label Carlsbad's Acyclovir tablets as made in Asia (In-PharmaTechnologist)
  • The role of big data in medicine (McKinsey)
  • American College of Physicians Urges Greater Generic Use (Reuters) (Washington Post) (ACP)
  • Boehringer Ingelheim's Pradaxa gets new indication (DSN) (PharmPro)
  • How Do You Keep Vaccines Cool? Try Spacecraft Insulation (NPR)
  • Activists promote opiate antidote as US overdoses surge (Reuters)

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

  • Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Retinoblastoma (Press)
  • AMAG Pharmaceuticals Responds to Recent Complete Response Letter From the FDA for the Single-Dose, Preservative-Free Vial of Makena (Press)
  • Genmab Announces Ofatumumab Phase III Study in Follicular Lymphoma to be Stopped Following Planned Interim Analysis (Press)
  • Samumed Completes Phase II Study for Its Potential Treatment of Androgenetic Alopecia: Safety Data Show No Serious Adverse Events in Any Treated Patient (Press)
  • Aurinia Pharmaceuticals Announces Outcome from Data and Safety Monitoring Board for Its Phase 2b Study in Lupus Nephritis – Study to Continue as Planned (Press)
  • Ocular Therapeutix Begins Enrollment in its Second Phase 3 Clinical Trial for DEXTENZA for the Treatment of Allergic Conjunctivitis (Press)

US: Medical Devices

  • FDA Warns Of Coating Separation Risks For Intravascular Devices (Gray Sheet-$) (Focus)
  • FDA Releases Report Detailing Problematic Laboratory-Developed Tests (Harvard Bill of Health) (NYTimes) (Focus)
  • Decoding a Baby's Genome in 26 Hours (IEEE Spectrum)
  • Video Game Is Built to Be Prescribed to Children With A.D.H.D. (NYTimes)
  • VolitionRx demonstrates NUQ blood test detects lung cancers with more than 90% accuracy (MNT)
  • Tiny iViz Ultrasound from FUJIFILM SonoSite Approved by FDA (medGadget)
  • Angiodroid yanks 510(k) over FDA CO2 clearance issue (MassDevice)

US: Assorted and Government

  • Oxycontin Maker Says Chicago Trying To Usurp FDA's Authority (Forbes)
  • Lawmakers: Obama Should Request Funds To Put UDIs In CMS Claims (InsideHealthPolicy-$)
  • Pfizer's Huge Deal Could Work, but With Adverse Effects (NYTimes)
  • Doctors Still Shouldn't Use Cost To Decide What Drugs To Use (DrugWonks)
  • NIH kicks off cohort grants for precision medicine (Gov Health IT)
  • Cymbalta Users Appeal To 9th Circ. In Withdrawal Suit (Law360-$)
  • Many cancer drugs are put in highest-cost tier by insurance companies (Washington Post)
  • Up Scope! Pharma, Periscope and Some Regulatory Questions (Eye on FDA)
  • GAO report highlights Part B drug costs (BioCentury) (FierceHealthPayer) (GAO Report)
  • Something Old, Something New: FDA's Guidance Documents on Labeling of Genetically Engineered Foods – Including Salmon (FDA Law Blog)
  • Ghostbusters – Phantom "Parallel Claim" Exorcized by Generic Drug Preemption (Drug and Device Law)

Upcoming Meetings and Events              


  • Demand Soars For Parallel EMA-HTA Advice (SCRIP-$)
  • EMA Spells Out New Expectations for Adaptive Pathways Applications (Focus)
  • Interview: Current 'Wait-And-See' State Of EU Regulatory Reforms Not Good For Medtech (SCRIP-$)
  • Aduro Biotech Receives Orphan Drug Designation in the European Union for CRS-207 for the Treatment of Mesothelioma (Press)
  • XBiotech Provides Update on Phase III Oncology Study in Europe (Press)
  • BioMarin's real world data sways NICE on orphan drug Vimizim (PMLive) (EPR)
  • European Commission Approves Reconciliation of Indications for nivolumab Under the Opdivo® European Marketing Authorization Application (Press)
  • Sobi and Biogen's ELOCTA® (rFVIIIFc) Approved in Europe for the Treatment of Haemophilia A (Press)
  • EU study using nanoparticles, low-dose radiation to aid companion diagnostics in battling cancer (FierceMedicalDevices)
  • Amgen gets EU conditional marketing approval for Blincyto to treat ALL (PharmaLetter-$)


  • Mylan launches Canadian adherence program for Mavik patients (DSN)


  • India, Germany to begin joint research in priority areas in health research & biomedical sciences (PharmaBiz)
  • Indian court says officials can process Reliance package insert for cancer drug (FiercePharmaAsia)
  • India-EU trade talks back on next year, GVK issue sidelined (FiercePharmaAsia)
  • Lupin Top Execs On Asia Push And Japan Generic Consolidation (SCRIP-$)
  • Lupin receives FDA approvals for generic loestrin tabs (ExpressPharma)


  • Australia cuts down public health bill by investing in new medicines under PBS (PharmaLetter-$)

Other International

  • WHO Director-General addresses Regional Committee for Africa (WHO)
  • Boy dies of Ebola in Liberia, first such fatality in months (Reuters)

General Health & Interesting Articles

  • Scientists Discover the Secret Behind Bacterial Gene Transfer (ICT)
  • Colorectal screening up, racial disparity down in New York City (Reuters)
  • He went from a playful little boy to 'a zombie.' Why wouldn't the doctors listen? (Washington Post)
  • Four in 10 say they know someone who has been addicted to prescription painkillers (Washington Post)
  • The surprising reason for one group's Alzheimer's 'curse' (Washington Post)

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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