Regulatory Recon: Gilead's Odefsey Approved Using Priority Review Voucher, New Questions Emerge on ROCKET AF Trial (2 March 2016)

Posted 02 March 2016 | By Michael Mezher 

Regulatory Recon: Gilead's Odefsey Approved Using Priority Review Voucher, New Questions Emerge on ROCKET AF Trial (2 March 2016)

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 Issues Guidance on Zika in Human Cell and Tissue Products (Focus) (FDA)
  • Olympus To Pay $646M To Settle Kickback, FCPA Probes (Law360-$) (Gray Sheet-$) (STAT) (DoJ)
  • Gilead Wins Approval of TAF-Based HIV Drug Using Priority Review Voucher (Reuters) (SCRIP-$) (PMLive) (Press)
  • Document Claims Drug Makers Deceived a Top Medical Journal (NYTimes) (NEJM)
  • Have a Problem? Contact the New Ombudsman in the Office of Regulatory Affairs (FDA Voice)
  • FDA Science Board Addresses US Opioid Epidemic (Focus) (AP)
  • FDA and Product Jurisdiction: Time for Reforms (FDLI)
  • Did The FDA's Actions On The Essure Contraceptive Go Far Enough? (Forbes)
  • Drug ad backlash doesn't deter Cambridge biotech (Boston Globe)

In Focus: International

  • Meeting growing Asia–Pacific demand for medical technology (McKinsey)
  • UK cost agency rejects leukaemia drug from J&J and AbbVie (Reuters)
  • Merck begins late-stage trials of Humira biosimilar (Pharmafile)
  • Ezetimibe gets new backing from MHRA and NICE (PharmaLetter-$)
  • Chinese Heparin Sourcing Questions Resurface After ANSM Inspection (Focus)
  • Hepatitis C cures available today for as low as $6.20 a prescription in Australia (PharmaLetter-$)
  • DNDi Begins Quest For Sub-$200 Hep C Combo With Malaysia Trial Plan (PharmAsiaNews-$)

US: Pharmaceuticals & Biotechnology

  • How this 'map' of chemicals could help reduce animal testing (Washington Post)
  • Pioneering apoptosis-targeted cancer drug poised for FDA approval (Nature-$)
  • Oncology Trial Design Is Improving, But Still Has a Ways to (Thomson Reuters)
  • Mylan's EpiPen Exclusivity Saved Again As Teva Reports CRL (Pink Sheet-$)
  • Drug delivery market to reach $251bn by 2019 (In-PharmaTechnology)
  • IBM's Cancer Moonshot: Using Computer Science To Battle Tumors (Forbes)
  • Duchenne patient advocacy group lauds Sarepta for 'transparency' (Boston Business Journal)
  • FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT (Harvard Bill of Health) (Focus)
  • Dr. Holbrook Kohrt, Hemophiliac Who Made the Condition a Crusade, Dies at 38 (NYTimes)
  • Breast cancer only pharma pipeline with over 1,000 drug in development (PharmaLetter-$)
  • Juno and Kite fight it out to be first to market (EP Vantage)
  • Using old drugs to treat new viruses (MNT)
  • Therapy focus – PARP inhibitor class set to come of age in 2016 (EP Vantage)
  • Five Questions For Boehringer Ingelheim's Data Boss (SCRIP-$)
  • Electronic records didn't eliminate medical errors, they just created some new ones (MedCityNews)
  • Novo Nordisk and AstraZeneca seek tonic from key drug trials (Reuters)
  • Quality by Design Part 1: You Can't Design Something You Don't Understand (GxP Lifeline)
  • Tarantula toxin may yield non-opioid treatments for chronic pain (BioPharma-Reporter)

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

  • Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea (PLoS)
  • Aurina Receives FDA Fast Track Designation for Voclosporin for the Treatment of Lupus Nephritis (Press)
  • BioMarin Receives Orphan Drug Designation From FDA for First AAV-Factor VIII Gene Therapy, BMN 270, for Patients With Hemophilia A (Press)
  • Genentech: FDA Accepts For Review Supplemental BLA Of Xolair (RTTNews)
  • CEL-SCI Reports Monthly Patient Enrollment in February for Its Phase 3 Head and Neck Cancer Trial (Press)
  • GlycoMimetics Announces Initial Clinical Data from Phase 1 Portion of Clinical Trial of GMI-1271 in AML Patients (Press)
  • Nordic Nanovector: Late-Breaking Abstract on Betalutin Phase 1/2 Study Accepted for Presentation at American Association for Cancer Research Annual Meeting 2016 (Press)

US: Medical Devices

  • New NIST Method May Find Elusive Flaws in Medical Implants and Spacecraft (NIST)
  • FDA warns of dangerous errors made during implantation of Abbott's MitraClip (Fierce) (MedpageToday) (FDA) (Abbott)
  • Recent US FDA regulatory updates you should know about (Emergo)
  • Endo to terminate vaginal mesh manufacturing to avoid litigation (Fierce)
  • FDA accepts HDE submission from InVivo for Neuro-Spinal scaffold (MassDevice)
  • Whole-exome sequencing: A rational approach for 'diagnostic odyssey' patients (MNT)
  • Novel device measures stiffness and stickiness of red blood cells (MNT)
  • Dell, Zebra Medical offer machine learning algorithms for medical image analysis (Fierce)
  • Philips receives 510(k) clearance of Care Orchestrator, next generation cloud-based clinical management software for patients with sleep and respiratory conditions (Press)
  • Thermo Fisher Scientific Announces Expanded FDA Clearance for its B·R·A·H·M·S PCT Sepsis Biomarker (Press)
  • Tyber Medical Announces FDA 510(k) Clearance Of BioTy, A Modified Surface Treatment (Press)
  • NEC Display MD211G5 Diagnostic Display Receives FDA Clearance for Use in Tomosynthesis (Press)
  • Edwards SAPIEN XT Valve Receives FDA Approval For Pulmonic Procedures (Press)
  • Dictum Health's IDM100 Tablet FDA Cleared (medGadget)

US: Assorted & Government

  • Donald Trump, bad science, and the vitamin company that went bust (STAT)
  • HHS Announces Agreement on Health Data Interoperability (MedpageToday)
  • PhRMA suit seeks to thwart Ohio drug price initiative (BioCentury)
  • Key Securities Litigation Issues For Life Science Cos. (Law360-$)
  • U.S. group prepares Ohio ballot push for medical marijuana (Reuters)
  • Chicago panel explores the world of drug pricing (AHCJ)

Upcoming Meetings & Events


  • WHO Director-General addresses UK medicines regulatory authority (WHO) (MHRA)
  • Top 10 medicines issued in England by prescription cost in 2014-15 (Pharmafile)
  • Notified Body Resource Problems? We Know, Says TEAM-NB, But There Is 'No Easy Fix' (Clinica-$)
  • Added benefit of Eylea in choroidal neovascularization not proven, says IQWiG (PharmaLetter-$)
  • EU Patent Court System Nears - But Would A Brexit Stymie The Schedule? (SCRIP-$)
  • Becton Dickinson wins CE Mark for blood separation tech (MassDevice)
  • Nivolumab recommended for advanced kidney cancer by European Medicines Agency (Pharmaceutical Journal-$)
  • Russia Rebuffs Latest Move To Remove Local Clinical Trial Requirement For Drugs (SCRIP-$)
  • Aveo's Tivozanib Lives to Fight Another Day With EU And Russian Filings (SCRIP-$)
  • Health Programme 2014-2020: Commission adopts Work Programme for 2016 (European Commission)


  • Asia Regulatory Roundup: CFDA Builds Priority Review Pathway for Drug Approvals (Focus)
  • CFDA releases draft of inspection guidelines (BioCentury)
  • Chi-Med initiates sulfatinib Phase II clinical trial in thyroid cancer (Press)


  • India Sovaldi Opposition Hearing Ends; EU Case Looms (SCRIP-$)
  • US Medtech Wants More Clarity On India's New Rule For Ablation Devices (SCRIP-$)
  • Notices issued over imposition of excise duty on medicines (Economic Times)
  • Heart and lung diseases are the top killers in the country (Economic Times)
  • Pharmexcil wants govt to devise strategy for payment realizations of exporters from some countries (PharmaBiz)
  • Maha FDA directs hospitals not to force patients to buy medicines from in-house pharmacies (PharmaBiz)
  • Aurobindo & Zydus Cadila Announce USFDA Approvals For Generic Acetadote & Glucovance (24 Insight)
  • Cadila Receives Indian Process Patent For Sitagliptin (Januvia) (24 Insight)


  • Valeant CEO Races to Repair Drug Maker's Reputation (WSJ-$)
  • Canada Has Just Approved This Drug For HIV Prevention (BuzzFeed)

Zika Virus

  • Cuba reports first case of Zika in Venezuelan doctor (Reuters)
  • Slovakia confirms first case of Zika virus in country: minister (Reuters)

Other International

  • Medicines New Zealand says PHARMAC model needs updating (PharmaLetter-$)
  • Statement on the 8th IHR Emergency Committee meeting regarding the international spread of poliovirus (WHO)
  • Promoting inclusive growth through better regulation (OECD)

General Health & Other Interesting Articles

  • Scott Kelly: A Giant Step for Health and Medicine? (Forbes)
  • Want To Change Someone's Mind About Vaccines? Here's A Start (Forbes)
  • This Gene Could Turn Your Hair Gray (NPR)
  • Keeping the brain active may not delay signs of Alzheimer's (Reuters)
  • U.S. panel not sure elderly need routine vision checks during physicals (Reuters)

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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