Regulatory Recon: EU Reaches Agreement on Medical Device, IVD Regulations Sen. Alexander Opposes FDA Funding Boost (26 May 2016)

Posted 26 May 2016 | By Michael Mezher 

Regulatory Recon: EU Reaches Agreement on Medical Device, IVD Regulations Sen. Alexander Opposes FDA Funding Boost (26 May 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

  • Approving Sarepta's Muscular Dystrophy Drug Could Force FDA To Get Creative (Forbes)
  • Angry customer files class action suit against Theranos (The Verge)
  • Most Drugs Aren't Tested on Pregnant Women. This Anti-nausea Cure Shows Why That's a Problem (ProPublica)
  • Reproducibility: Crisis or Not? (In the Pipeline)
  • Could Alzheimer's Stem From Infections? It Makes Sense, Experts Say (NYTimes)
  • Sen. Alexander opposes FDA funding surge (BioCentury)
  • The Drop in OPDP Enforcement (Eye on FDA)
  • Craving Growth, Walgreens Dismissed Its Doubts About Theranos (WSJ-$)
  • Washington Grapples with a Thorny Question: What Is a GMO Anyway? (MIT Technology Review)

In Focus: International

  • EU Reaches Agreement on New Medical Device, IVD Regulations (Focus) (MedicalDevicesLegal)
  • Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations (Focus)
  • Korean Regulatory Overhaul To Cut R&D, Approval Periods (PharmasiaNews-$)
  • He Survived Ebola. Now He's Fighting to Keep It From Spreading (NYTimes)
  • Nice does not recommend Eli Lilly's lung cancer drug in draft guidance (Pharmafile)
  • NICE backs Sanofi's Jevtana in prostate cancer (PharmaLetter-$)
  • World Health Assembly agrees new Health Emergencies Programme (WHO)
  • WHO Aims To Reform Itself But Health Experts Aren't Yet Impressed (NPR)

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US: Pharmaceuticals & Biotechnology

  • PureTech Enters CAR-T With Vor BioPharma (Start Up-$)
  • Changing The Subject (Part 1): Stop Trying To "Win" The Drug Pricing Debate (RPM Report-$)
  • Changing the Subject (Part 2): Turning Turing Around By Offering A "National Center Of Pharmaceutical Supply" (RPM Report-$)
  • The American Heart Association's Strong Stance Against Science (CardioBrief)
  • Company Calls on FDA to Speed Authorization of Genetically Modified Mosquitoes to Fight Zika Virus (Focus)
  • US FDA Advisory Committee Supports Sanofi's iGlarLixi (Insulin Glargine and Lixisenatide) Injection for Type 2 Diabetes – MAY 25, 2016 (Tarius)
  • After Failed Trial, Forum CEO Dunsire Leaves, Company's Fate Unclear (Xconomy)
  • What Comes First In Consumer Sector: FDA Excessive Claims Finding Or Facility Inspection? (Pink Sheet-$)
  • Shift from blockbuster biologics driving single-use uptake, GE Healthcare (BioPharma-Reporter)
  • Lung cancer patients at bigger cancer centers may have better outcomes (Reuters)
  • Some OTC Switch Benefits Are Intangible, But Influential – CDER's Ganley (Tan Sheet-$)
  • Harnessing nature's vast array of venoms for drug discovery (MNT)
  • Opioids Often Ineffective for Low Back Pain (NYTimes)
  • CGT to test scaffold tech for commercial-scale T-cell production (BioPharma-Reporter)
  • Biomarkers triple clinical trial success rate, says report (Outsourcing-Pharma)
  • Regeneron Pharmaceuticals Takes Over Sponsorship Of America's Top Science Contest (Forbes)
  • Sam Eldessouky named new senior vice president and corporate controller at Valeant (Pharmafile)
  • Polio-free world? Not if scientists refuse to destroy their research specimens (STAT)

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

  • Galapagos, Gilead include high dose in PhIII RA trial following talk with FDA (Fierce) (Press)
  • Chugai's Bispecific Antibody "ACE910/Emicizumab" Phase l Data in Patients with Hemophilia A Published in The New England Journal of Medicine Online (Press)
  • Ionis Pharmaceuticals Provides Update on IONIS-TTR Rx Program (Press)
  • Acucela Announces Top-Line Results from Phase 2b/3 Clinical Trial of Emixustat (Press)
  • AVEO Announces Dosing of First Patient in the Pivotal Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma (Press)

US: Medical Devices

  • Just How Accurate Are Fitbits? The Jury Is Out (NYTimes)
  • Roche CMV Test for Hematopoietic Stem Cell Transplants Gets FDA OK (GenomeWeb)
  • Google Glass Gets a Second Life in the ER (IEEE)
  • Mammography Facility Adverse Event and Action Report - May 25, 2016: Delano Regional Medical Center (FDA)
  • Medtronic taps Qualcomm to build smaller, cheaper continuous glucose monitors (MobiHealthNews)

US: Assorted & Government

  • On Capitol Hill, CHIME, HIMSS push for cybersecurity leadership at HHS (MedCityNews)
  • Health Startup Led by Ex-United Manager Goes Where Rivals Quit (Bloomberg)
  • Insurers Seek Big Premium Boosts (WSJ-$)
  • It's Still Hard To Get Birth Control Pills In California Without A Prescription (NPR)
  • FDA issues final food defense regulation (Press)
  • Opportunities for Increased Drug Sales to Department of Veteran's Affairs (National Law Review)

Upcoming Meetings & Events


  • The Hepatitis C Trust considers legal action over cap on NHS patients allowed to seek treatment (Pharmaceutical Journal-$)
  • Transatlantic deal could increase EU pharma exports by $10 billion, report says (PharmaLetter-$)
  • Europe Floats Proposal On Drug Cooperation In TTIP (Law360-$)
  • Device Makers To Prepare For Big Changes Under EU Radio Equipment Directive (SCRIP-$)
  • ACT wins expanded CE Mark for esophageal cooling device (MassDevice)


  • WuXi NextCODE unit launches China Precision Medicine Cloud with Huawei (Fierce)


  • Indoco Receives USFDA Nod For Its Goa Plant (24 Insight)
  • Jubilant Life gets nod for Sodium Chloride injection (Economic Times)
  • NPPA cuts antibiotic, stomach ulcer and abortion drug prices by 30% (Economic Times)
  • Strides Shasun gets US health regulator tentative nod for HIV treatment drug (Economic Times)


  • Prescription medicine clinical units (TGA)
  • Consultation: Proposed amendments to the Poisons Standard - ACCS and Joint ACCS/ACMS, July 2016 (TGA)
  • Half Yearly Performance Report Snapshot - July to December 2015 (TGA) ( Infographic)
  • Illumina Registers MiSeqDx for Clinical Use in Australia (GenomeWeb)
  • Australian small cap biotech Biotron ticks higher on Zika screen news (Fierce)


  • Health Canada to Develop Better Risk Communications on Essure Contraceptive Devices (Focus)
  • Ortho Kinematics wins Health Canada nod for VMA system (MassDevice)

Other International

  • NZ Plans Revamp Of "Outdated" Rules To Attract More Clinical Trials (Clinica-$)

General Health & Other Interesting Articles

  • After skin cancer, sun protection is still spotty (Reuters)
  • A Low-Salt Diet May Be Bad for the Heart (NYTimes)

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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