Regulatory Focus™ > News Articles > Regulatory Recon: France Gets New Top Regulator (4 August 2014)

Regulatory Recon: France Gets New Top Regulator (4 August 2014)

Posted 04 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: France Gets New Top Regulator (4 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • FDA approves BI's Jardiance to treat type 2 diabetes (FDA)
  • Sanofi/Genzyme Pompe drug Lumizyme gains expanded use, loses REMS (FDA) (SCRIP-$) (Press)
  • FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It Again (FDA Law Blog)
  • FDA’s Plaisier: GMP Oversight Must Shift To Outcomes Model (Pink Sheet-$)
  • Woodcock: To Revolutionize Antibiotic Pipeline Start With Rapid Diagnostics (Pink Sheet-$)
  • EPO biosimilar to be submitted to US FDA in next 12 months, says Hospira (BioPharma Reporter)
  • FDA suggested deregulation affects smart scales, fertility thermometers, and more (MobiHealthNews)
  • FDA panel narrowly OKs Cohera Medical's TissuGlu (Mass Device)

In Focus: International

  • France Appoints Dominique Martin to Head of ANSM (ANSM)
  • EMA Out With Concept Paper on "Good Biomarker Practices" (EMA)
  • September wait for unveiling of EU parliament’s new medtech reg rapporteur (Clinica-$)
  • Italian presidency earmarks drug/device borderline guidance update as a priority (Clinica-$)
  • Transluminal Tech lands E.U. win for bioabsorbable vascular closure (Mass Device) (Press)
  • New China FDA Device Regs Have Companies Scrambling To Comply (Gray Sheet-$)
  • Is the WHO's "biological qualifier" really needed? (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • FDA approves BI's Jardiance to treat type 2 diabetes (FDA)
  • Sanofi/Genzyme Pompe drug Lumizyme gains expanded use, loses REMS (FDA) (SCRIP-$) (Press)
  • FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It Again (FDA Law Blog)
  • FDA’s Plaisier: GMP Oversight Must Shift To Outcomes Model (Pink Sheet-$)
  • Woodcock: To Revolutionize Antibiotic Pipeline Start With Rapid Diagnostics (Pink Sheet-$)
  • FDA issues statement regarding call to expedite process for Ebola vaccine (WSBTV)
  • USP, Apotex and researchers weigh in on FDA’s draft guidance on biosimilarity (BioPharma Reporter)
  • FDA Approves Baxter’s FLEXBUMIN 5%, First and Only 5% Human Albumin Solution in a Flexible Container (Press)
  • New FDA Mapp on Phone Meetings With the Office of Pharmaceutical Science (FDA)
  • FDA AdComm to Discuss Novo Nordisk's Liraglutide for Weight Management (FDA) (Pink Sheet-$)
  • California Pharmacy Board Postpones Decision on Rx Label Translations (CA Healthline)
  • Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014 (RxTrace)
  • Sarepta Restores CEO's Ability to Communicate With FDA (Fierce)
  • Dr. Kent Brantly, American With Ebola, Got Experimental Serum, Group Says (NBC) (But Not Tekmira)

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

  • EPO biosimilar to be submitted to US FDA in next 12 months, says Hospira (BioPharma Reporter)
  • AbbVie Brain Tumor Treatment Gets U.S., EU Orphan Designation (WSJ-$) (Press)
  • Amgen blood cancer drug succeeds in late-stage study (Reuters) (Fierce)
  • NanoViricides to Restart its Anti-Ebola Virus Drug Development Program (Press)
  • Biota’s disappointing flu medicine no bettter than placebo in mid-stage trials (MedCity News) (SCRIP-$)
  • NIH planning Phase I Ebola vaccine trial (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Start-Ups Work on Biotech Drugs for Pets (NYTimes)
  • Teva gets more than half of U.S. Copaxone patients converted to long-lasting version (Fierce)
  • US Capitol Capsule: NIH chief 'cranks it up' with captains of industry (SCRIP-$)

US: Medical Devices

  • FDA suggested deregulation affects smart scales, fertility thermometers, and more (MobiHealthNews)
  • FDA panel narrowly OKs Cohera Medical's TissuGlu (Mass Device)
  • Special Commentary: Food and Drug Administration and American Glaucoma Society Co-sponsored Workshop: The Validity, Reliability, and Usability of Glaucoma Imaging Devices (PubMed)
  • Intellijoint’s Hip Replacement Positioning System Cleared in U.S. (MedGadget)
  • No frills here: Smith & Nephew to offer cheap hip and knee replacement services in U.S. (MedCity News) (Mass Device)
  • ElMindA Announces FDA Clearance of BNA Analysis System (Press)

US: Assorted And Government

  • New FDA Guidances for July 2014 (CATO)
  • A Look Into the Influence of OIRA (ProPublica)
  • FDA Anticipates 600 Submissions for its Commissioner's Fellowship Program (FDA)
  • President Signs Veterinary Medicine Mobility Act into Law (Congress)
  • Who Invited Ebola to Atlanta? (Bloomberg View) (NYTimes)
  • Why you’re not going to get Ebola in the U.S. (WaPo) (NPR) (Forbes)

Europe

  • France Appoints Dominique Martin to Head of ANSM (ANSM)
  • EMA Out With Concept Paper on "Good Biomarker Practices" (EMA)
  • EMA revises guidance on developing flu vaccines (BioPharma Reporter)
  • September wait for unveiling of EU parliament’s new medtech reg rapporteur (Clinica-$)
  • Italian presidency earmarks drug/device borderline guidance update as a priority (Clinica-$)
  • Adaptive Licensing: Could patients be the answer to the data problem? (PharmaPhorum)
  • EMA Reflection Paper on Use of Cocrystals (EMA)
  • EMA Q&A Document on Gluten Excipients (EMA)
  • Concept paper on revision of guideline on epidemiological data on blood-transmissible infections (EMA)
  • Draft concept paper on guideline on the clinical investigation of human normal immunoglobulin for intravenous administration and core summary of product characteristics (EMA)
  • Transluminal Tech lands E.U. win for bioabsorbable vascular closure (Mass Device) (Press)
  • Fewer ‘pay-for-delay’ agreements are likely but they might not disappear altogether (Pharma Letter-$)
  • ABPI president: NICE needs political reform (Pharmafile)
  • Insmed Preparing EMA Filing in 2014 for Lung Infection Drug Arikayce (Press)
  • Vertex scores 250 new Kalydeco patients with EMA approval (Fierce)
  • U.K. and Novartis begin price negotiations on Bexsero (Fierce) (DOH)
  • Germany gives an initial 'no additional benefit' on Biogen Idec's Tecfidera (Fierce)
  • Busted! Tainted EU supplements exposed (Nutra Ingredients)
  • Biosimilars’ Next Hurdle In EU Is Physician Opposition To Extrapolation (Pink Sheet-$)

India

  • Pfizer Locks Down Plant After Safety Concerns Raised (Economic Times)
  • Different drugs with same name pose danger to patients (DNA India)

China

  • New China FDA Device Regs Have Companies Scrambling To Comply (Gray Sheet-$)

Japan

  • Kyowa submits application in Japan for antithrombin product (BioCentury)

Australia

  • TGA Doesn't Follow FDA on Power Morcellators (TGA)

Other International

  • Is the WHO's "biological qualifier" really needed? (SCRIP-$)

Clinical Trials

  • Cancer Trials & Tribulations: Combinations Are Easier Said Than Done (PAM-$)
  • Pfizer and Roche join ADDPLAN DF consortium (BioCentury)

General Regulatory And Interesting Articles

  • Ebola Vaccine Possible, but Many Doubts Persist (NYTimes)
  • Why Treating Ebola With An Experimental Serum Might Help (NPR)
  • The case for medical LSD, mushrooms, and ecstasy (Vox)

Regulatory Reconnaissance #371 – 4 August 2014

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 @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe