Regulatory Focus™ > News Articles > Regulatory Reconnaissance (19 November 2013)

Regulatory Reconnaissance (19 November 2013)

Posted 19 November 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.

In Focus: US

  • Woodcock, Other FDA Regulators Weigh in on Breakthrough Therapy Designation Progress (NEJM)
  • Compounding Law: How Many "Outsourcing Facilities" Will Emerge? (Pink Sheet-$)
  • What's driving the surge in new-drug approvals? (McKinsey)
  • Teva withdraws balugrastim BLA (BioCentury) (PMLive)
  • New Scrutiny for Preamendment Medical Devices (NYTimes)
  • Nine diet supplements contain amphetamine-like compound (USA Today)

In Focus: International

  • EMA Publishes 19 Bioequivalence Guidances (EMA)
  • UK Weighs in on EMA Transparency Plans (UK)
  • NICE sending "difficult" signals over antibiotics, says ABPI (Pharma Times)
  • GlaxoSmithKline's asthma drug Relvar approved in Europe (Reuters) (Press) (SCRIP-$) (Pharma Letter-$) (BioCentury) (Pharma Times)
  • Boston Scientific Vercise™ Deep Brain Stimulation System Receives CE Mark Approval for Treatment of Dystonia (Press)

US: Pharmaceuticals/Biotechnology

  • Woodcock, Other FDA Regulators Weigh in on Breakthrough Therapy Designation Progress (NEJM)
  • Compounding Law: How Many "Outsourcing Facilities" Will Emerge? (Pink Sheet-$)
  • What's driving the surge in new-drug approvals? (McKinsey)
  • Merck's Noxafil IV solution gains FDA priority review  (SCRIP-$) (Press) (BioCentury)
  • US FDA accepts AstraZeneca's NDA for naloxegol (Pharma Letter-$) (Press)
  • Teva withdraws balugrastim BLA (BioCentury) (PMLive)
  • Breakdown of FDAAA Completed Pediatric Studies (FDA)
  • FDA Approves Pfizer's SNDA for Xeljanz (Press)
  • Kythera Readies NDA For Double Chin Drug ATX-101 (Pink Sheet-$)
  • No Evidence That Statins Impact Cognitive Function (Forbes)
  • P&G Asks FDA For Blanket Limits On PPI Labeling (Tan Sheet-$)
  • AbbVie hepatitis C drugs show high cure rate ahead of filing  (Reuters) (SCRIP-$) (Pharma Letter-$) (BioCentury) (Fierce)
  • Actavis seeks approval for generic testosterone-replacement drug (DSN)
  • Pradaxa antidote works fast, completely in small trial (Reuters) (Press)
  • Merck trial shows more melanoma cancer patients respond to drug (Reuters) (SCRIP-$) (PMLive) (Pharma Times) (Fierce)
  • J&J's Janssen Loses $11 Million Jury Verdict Over Topamax (Bloomberg)
  • Bayer's $74M Cipro Pay-For-Delay Deal Approved In Calif. (Law 360-$)
  • Gilead's Idelalisib Significantly Reduces Rate of Disease Progression or Death in Phase 3 Chronic Lymphocytic Leukemia Study (Press)

US: Pharmaceuticals and Biotechnology: General

  • Medicare's Failure to Track Doctors Wastes Billions on Name-Brand Drugs (ProPublica)
  • Obamacare Failure May Shave 30% From U.S. Drug Sales (Bloomberg)
  • Trade talks spur fears of unchecked drug prices (The Hill)
  • Bavarian Nordic delivers smallpox vaccine to US under $549m contract (SCRIP-$)
  • Cialis (tadalafil) marks 10 years since U.S. approval (Eli Lilly)

US: Medical Devices

  • New Scrutiny for Preamendment Medical Devices (NYTimes)
  • Medical Device Innovation Consortium Works to Reform Approval Process (MDDI)
  • Key Open Questions for FDA's Upcoming Report on Regulation of Health IT (Inside Medical Devices)
  • Cohera Medical, Inc. Completes Fourth and Final Module in the Premarket Approval (PMA) Application for TissuGlu Surgical Adhesive (Press)

US: Dietary Supplements

  • Nine diet supplements contain amphetamine-like compound (USA Today)
  • Hi-Tech Pharmaceuticals Sues The FDA For "Bullying Tactics" (Press)

US: Assorted And Government

  • U.S. Senate votes to extend worldwide anti-AIDS program (Reuters)
  • Dems propose back pay for furloughed contract workers (The Hill)

Upcoming Meetings And Events

  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA Publishes 19 Bioequivalence Guidances (EMA)
  • GlaxoSmithKline's asthma drug Relvar approved in Europe (Reuters) (Press) (SCRIP-$) (Pharma Letter-$) (BioCentury) (Pharma Times)
  • Boston Scientific Vercise™ Deep Brain Stimulation System Receives CE Mark Approval for Treatment of Dystonia (Press)
  • Gilead's Vitekta gains European Commission approval (Pharma Letter-$) (BioCentury) (Pharma Times)
  • UK Weighs in on EMA Transparency Plans (UK)
  • NICE sending "difficult" signals over antibiotics, says ABPI (Pharma Times)
  • EMA Reflection Paper on the use of Pleuromutilins in Food-Producing Animals (EMA)
  • Gentium Receives EMA Orphan Drug Designation for Defibrotide for the Prevention of GvHD (Press)

Asia

  • Eight kids die in Kashmir due to suspected adverse events of pentavalent vaccine (PharmaBiz)

Other International

  • Health Canada: Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices (HC)

General Regulatory And Interesting Articles

  • Futuristic "Human-on-Chip" Models Will Help Drug Development (Xconomy)
  • Taking birth control pill for years may double glaucoma risk (CBS) (NPR)
  • Salk scientists for the first time generate 'mini-kidney' structures from human stem cells (EurekAlert)

Regulatory Reconnaissance #205 - 19 November 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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