Regulatory Recon: FDA Clears Xarelto Despite Faulty Trial Device Sen. Markey Calls on FDA to Curb Off-Label Fentanyl Prescribing (12 October 2016)

Posted 12 October 2016 | By Michael Mezher 

Regulatory Recon: FDA Clears Xarelto Despite Faulty Trial Device Sen. Markey Calls on FDA to Curb Off-Label Fentanyl Prescribing (12 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA clears Xarelto blood thinner despite faulty trial device (Reuters) (CardioBrief) (FDA)
  • Generation Adderall (NYTimes)
  • FY 2016 Generic Approvals by FDA: A New Record Under GDUFA (Focus)
  • Is Biopharma Productivity In A Sharp Decline? (Forbes)
  • Use of controversial prostate cancer test may be holding steady (Reuters)
  • Making heparin safe (C&EN)
  • Senator Markey Calls for Swift Action to Curb Off-Label Fentanyl Prescribing (Markey) (Letter)
  • 5 retractions and a sack for Pfizer lead cancer researcher Min-Jean Yin (ForBetterScience) (Fierce)
  • FDA Accepts Coherus's ABLA For Neulasta Biosimilar (BigMoleculeWatch)
  • Rekindling cancer vaccines (Nature)
  • There is no such thing as "free" vaccines: Why we rejected Pfizer's donation offer of pneumonia vaccines. (MSF)
  • Say what? Compassionate use program? What compassionate use program? (Endpoints)
  • Where We Are/What We Have Done – Two Years After Releasing Our FDASIA 907 Action Plan (FDAVoice)
  • Sanofi-Pasteur's Southern Strategy Gets Its Own FDA Advisory Committee (Pink Sheet-$)
  • HHS Sponsors Commercial Manufacturing Tests for Ebola Vaccine (PharmaTech)
  • Regeneron and Vertex board members rake in highest pay in the S&P 500: Report (Fierce)
  • Diabetes, Diet and Shame (NYTimes)
  • How Tiny Are Benefits From Many Tests And Pills? Researchers Paint A Picture (KHN)
  • FDAAA Asked & NIH Answered: The Final Rule on Clinical Trials Registration and Results Reporting (FDA Law Blog)
  • Employers Shift Higher Health-Care Costs to Workers (WSJ)
  • Hospitals Say They're Being Slammed By Drug Price Hikes (KHN) (Forbes)
  • IBM Offering US Employees Watson Technology to Identify Cancer Treatments (WSJ) (IBM)

In Focus: International

  • Experts warn global goal to cure or treat Alzheimer's by 2025 is at risk (PharmaLetter-$) (Press)
  • Brexit turns UK earnings upside down (Financial Times)
  • The Chinese and European Pharmacopoeias – The new editions (EDQM)
  • Brexit: How To Avoid UK Regulatory Divergence And Medicines Access Delays (Pink Sheet-$)
  • IQWiG says added benefit of AstraZeneca's Onglyza not proven (PharmaLetter-$)
  • UK cancer cases to increase sharply, study finds (PharmaTimes)
  • Count Me In! China To Update Drug Coverage After Long Wait (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Highlights Of The FDA's Abbreviated New Drug Applications (Law360-$)
  • Envelope-specific antibodies and antibody-derived molecules for treating and curing HIV infection (Nature)
  • Pew: Problematic Antibiotic Labels Will Remain After FDA Guide Implemented (InsideHealthPolicy)
  • Synairgen slumps by a third as AstraZeneca ditches asthma drug study (Reuters)
  • AstraZeneca snaps up second Amgen biologics plant in Colorado (BioPharmaReporter)
  • Even partial steroid treatment can benefit extremely preterm infants, NIH study suggests (NIH)
  • PD-1 Drug Stakes First-Line Claim in NSCLC (Medpage)
  • Improving the Science of Measles Prevention—Will It Make for a Better Immunization Program? (PLOS) (PLOS)
  • Leveraging Real-World Evidence With Observational Studies (Cutting Edge Info)
  • Life Science Leaders Who Feel the Right Kind of Fear (Xconomy)
  • Transgene announce key partnership with Merck KGaA and Pfizer (Pharmafile)
  • Bispecific interest reaches a Crescendo (EPVantage)
  • Biotrial opens headquarters in North America (OutsourcingPharma)
  • Therapy focus – SMA pipeline contenders await nusinersen news (EPVantage)

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

  • Supernus clears PhII ADHD drug hurdle, but shares drip downward (Fierce) (BioCentury)
  • Priority Review for Neurocrine's valbenazine (Biocentury)
  • Regulatory T Cell Responses in Participants with Type 1 Diabetes after a Single Dose of Interleukin-2: A Non-Randomised, Open Label, Adaptive Dose-Finding Trial (PLOS)
  • Preliminary Phase Ib Clinical Study Results For Lenvatinib In Combination With Pembrolizumab In Selected Solid Tumors Presented At ESMO 2016 (Press)

US: Medical Devices

  • BioFire Gets 510(k) Clearance, CLIA Waiver for FilmArray Respiratory Panel EZ (GenomeWeb)
  • Illumina sinks on preliminary 3Q miss (BioCentury)
  • Medical Devices; Custom Devices; Technical Amendment (FDA)
  • FDA Finalizes Guidance On Medical Device Safety Evaluation (MassDevice)
  • 3 tips for managing your medical device design history file (MedCityNews)
  • Lupin, MonoSol Rx ink licensing deal for pediatric products (MassDevice)
  • U.S. Special Forces test Oska's Pulse anti-pain device (MassDevice)
  • BioStable Science & Engineering seeks FDA de novo indication for Haart 300 annuloplasty device (MassDevice)
  • St. Jude wins FDA nod, launches PressureWire X FFR system (MassDevice)
  • Titan Medical CEO Hargrove is out | Personnel Moves, Oct. 11, 2016 (MassDevice)
  • Medical device CRO expands footprint to meet growing demand (OutsourcingPharma)

US: Assorted & Government

Upcoming Meetings & Events


  • Bone Therapeutics long-serving CEO steps down, leaving interim successor in charge (Fierce)
  • ICMRA Capacity Building Project Schedule (ICMRA)
  • UK Diabetes prescriptions have risen by a third since 2011 (Pharmaceutical Journal)
  • France opens its first supervised injection center for drug users (Reuters)


  • Philippines set to roll out tough no-smoking law (Reuters)


  • Maha FDA trains officials for effective inspection of blood banks (PharmaBiz)
  • IPA Bengal branch holds workshop on 'Ensuring Data Integrity' (PharmaBiz)
  • TSPCB issues closure notice to polluting chemical unit in Hyderabad (PharmaBiz)


  • Compliance and education for listed medicines (TGA)
  • Consultation: diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen for oral use: proposed additional advisory statement for medicines (TGA)


  • As babies stricken by Zika turn 1, health problems mount (AP)
  • FDA Issues Emergency Use Authorization for Zika Virus Detection by RT-PCR Test to ARUP Laboratories (FDA)

Other International

  • More cholera cases registered in Yemen but disease not spreading: WHO (Reuters)
  • W.H.O. Urges Tax on Sugary Drinks to Fight Obesity (NYTimes)

General Health & Other Interesting Articles

  • Tradeoffs in Introduction Policies for the Anti-Tuberculosis Drug Bedaquiline: A Model-Based Analysis (PLOS)
  • Orthostatic Hypotension and the Long-Term Risk of Dementia: A Population-Based Study (PLOS)

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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