Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 December 2013)

Regulatory Reconnaissance (20 December 2013)

Posted 20 December 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

Your editor will be on break for the Holiday starting 21 December 2013, and returning on 2 January 2014. Regulatory Reconnaissance will not be published during this time.

In Focus: US

  • FDA task force aims to shorten lag time between device approval, insurer coverage (Modern Healthcare) (Gray Sheet-$)
  • Novartis Recalls About 5.3 Million Bottles of Sample Drugs (WSJ-$) (Market Watch)
  • Makers of tainted supplements have criminal pasts (USA Today)
  • FDA delays decision on approval for wider use of Amarin's Vascepa (Reuters) (AP)
  • Gilead's $1,000 Pill Could Eradicate Hepatitis C, But Ethical And Financial Challenges Loom (Forbes)
  • Conflicts over API Starting Materials Persist Despite ICH Q11 Guide (Gold Sheet-$)

In Focus: International

  • EU Clinical Trials Regulation Signed by Legislators (EU2013) (EFPIA)
  • French Constitutional Council gives the all-clear to biosimilar substitution (SCRIP-$)
  • "Teething Problems" Seen with FMD Implementation: No Shortages but Much Confusion (Gold Sheet-$)
  • Merck Fined $21M By French Regulators For Bad Behavior (Pharmalot) (Reuters)
  • CHMP Recommends Five Medicines for Approval (EMA)

US: Pharmaceuticals/Biotechnology

  • Novartis Recalls About 5.3 Million Bottles of Sample Drugs (WSJ-$) (Market Watch)
  • Baxter's Feiba gains FDA approval for prophylactic treatment of hemophilia A and B (Press) (Pharma Letter-$)
  • FDA delays decision on approval for wider use of Amarin's Vascepa (Reuters) (AP)
  • Gilead's $1,000 Pill Could Eradicate Hepatitis C, But Ethical And Financial Challenges Loom (Forbes)
  • Conflicts over API Starting Materials Persist Despite ICH Q11 Guide (Gold Sheet-$)
  • Industry Responds to FDA's Quality Metrics Initiative with Proposal to Report Trends, not Values (Gold Sheet-$)
  • FDA approves new label indications for Bayer's Advantage Multi (imidacloprid + moxidectin) in the U.S. (Press)
  • J&J Fights NAD Neutrogena Decision Assailing Sunscreen "Barrier" (Tan Sheet-$)
  • Warner Chilcott Sues Torrent To Block Generic Enablex (Law 360-$)
  • Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance (FDA)

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

  • Auxilium Pharmaceuticals, Inc. Submits Application To FDA Requesting Approval Of XIAFLEX For Concurrent Treatment Of Multiple Palpable Cords (Press)
  • FDA Accepts For Review ELIQUIS (apixaban) Supplemental New Drug Application for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the Reduction in the Risk of Recurrent DVT and PE (Press)
  • Onconova drops Ph III trial of rigosertib in pancreatic cancer (Pharma Letter-$)
  • Amgen reports more positive results for cholesterol drug (SCRIP-$) (BioCentury)
  • Hanmi does not infringe AstraZeneca's Nexium: U.S. court (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • 'Let the Crime Spree Begin': How Fraud Flourishes in Medicare's Drug Plan (ProPublica)
  • Doxil update: J&J strikes deal to manufacture Doxil itself at Ben Venue plant (Fierce)
  • Hypertension Guide May Affect 7.4 Million (NYTimes)
  • PBS Debate: Should doctors be paid by pharmaceutical companies to promote their drugs? (Policy and Medicine)
  • Florida Supreme Court rules execution drug is effective sedative (Reuters)
  • Poll: Americans Favor Age Restrictions On Morning-After Pill (NPR)

US: Medical Devices

  • FDA task force aims to shorten lag time between device approval, insurer coverage (Modern Healthcare) (Gray Sheet-$)
  • US FDA initiative to encourage regulatory DIY among firms (Clinica-$)
  • HHS Names New Health IT Czar (MedPage Today) (Fierce) (GovHealthIT)
  • Greatbatch submits PMA for spinal cord stim (Mass Device)
  • Philips receives FDA clearance for First-Ever Spectral Breast Density Measurement Application (Press)
  • Solana Surgical Receives FDA Clearance for the CrossCHECK Plating System (Press)

US: Dietary Supplements

  • Makers of tainted supplements have criminal pasts (USA Today)
  • Montana dietary supplement maker found in contempt of court (FDA)

US: Assorted And Government

Upcoming Meetings And Events

  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU Clinical Trials Regulation Signed by Legislators (EU2013) (EFPIA)
  • French Constitutional Council gives the all-clear to biosimilar substitution (SCRIP-$)
  • "Teething Problems" Seen with FMD Implementation: No Shortages but Much Confusion (Gold Sheet-$)
  • Merck Fined $21M By French Regulators For Bad Behavior (Pharmalot) (Reuters)
  • BIA: Political compromises could undermine EU trial reform (PMLive)
  • CHMP Recommends Five Medicines for Approval (EMA)
  • EU agency recommends J&J's new tuberculosis drug Sirturo (Reuters) (EMA)
  • European Medicines Agency (EMA) Continues Marketing Authorization Application (MAA) Review for Lymphoseek (Press)
  • Nearly 8% of hip implants not backed by safety evidence (MNT)
  • CHMP backs Exelixis' Cometriq (BioCentury) (Press) (SCRIP-$)
  • CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen (EMA)
  • CMDh: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels (EMA)
  • ENVI Discharges EMA's 2012 Budget (ENVI)
  • Baxter Completes CE Mark Approval for VIVIA Hemodialysis System in Europe (Press)
  • Pfizer, Germany agree on prices for Bosulif, Xalkori (BioCentury)
  • Zelboraf Pricing In Germany Still Tied Up By Crossover Trial Design (Pink Sheet-$)
  • ABPI reprimands for four pharma firms (PMLive)
  • Second pilot rapid assessment on 'Renal denervation systems for treatment-resistant hypertension' available (EUnetHTA)

Asia

  • Japan sees first filings for edoxaban in SPAF, VTE (SCRIP-$)
  • Daiichi may get Japanese experts to help Ranbaxy meet USFDA norms (India Times)
  • Approval of Additional Indication for Astellas' Hypnosedative, Dormicum in Japan (Press)

Other International

  • Improving the affordability, availability, and acceptability of health technologies for low- and middle-income countries (GHTC)

General Regulatory And Interesting Articles

  • Survey reveals regulatory agencies viewed as unprepared for nanotechnology (Press)
  • Who Says Laughter's the Best Medicine? (NYTimes)
  • New Optimized Coatings for Implants Reduce Risk of Infection (ICT)

Regulatory Reconnaissance #226 - 20 December 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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