Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Will EU Adaptive Licensing Changes Mean Less Market Exclusivity? (14 May

Regulatory Reconnaissance: Will EU Adaptive Licensing Changes Mean Less Market Exclusivity? (14 May 2014)

Posted 14 May 2014 | 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

  • FDA Study Offers Reassurance About Boehringer Ingelheim's Pradaxa (Forbes) (WSJ-$) (FDA) (FDA)
  • Nearly 60% of Firms with 510(k) Submissions Got FDA's Refuse-to-Accept Letters in 2013 (MDDI)
  • Bayer provides patient-level clinical trial data (BioCentury) (Pharma Letter-$) (Press)
  • Doubts Raised About Off-Label Use of Subsys, a Strong Painkiller (NYTimes)
  • Teva's Copaxone Suit Is "Absolutely Unprecedented," FDA Says (Pink Sheet-$) (Law 360-$)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • FDA Study Offers Reassurance About Boehringer Ingelheim's Pradaxa (Forbes) (WSJ-$) (FDA) (FDA)
  • Bayer provides patient-level clinical trial data (BioCentury) (Pharma Letter-$) (Press)
  • The Draft Guidance on Clinical Pharmacology Studies for Biosimilars - Is FDA Moving Forward, Sideways or Backwards by Retracing Steps Covered in the 2012 Draft Guidances? (FDA Law Blog)
  • Doubts Raised About Off-Label Use of Subsys, a Strong Painkiller (NYTimes)
  • Teva's Copaxone Suit Is "Absolutely Unprecedented," FDA Says (Pink Sheet-$) (Law 360-$)
  • Opinion: FDA Draft Guidance Takes the "Social" Out Of Social Media (Forbes)
  • Actavis Receives Final Approval for Generic Version of Exalgo (Press)

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

  • Kythera submits ATX-101 NDA for submental fat (BioCentury) (PBR)
  • Janssen files NDAs for long-acting antipsychotic drug to treat schizoaffective disorder (Press)
  • FDA Transfers Pain Med Orphan Drug Designation to Sorrento (Press)

US: Pharmaceuticals and Biotechnology: General

  • Drug Pricing: The root cause of the internet pharmacy debacle (S4S)
  • Why More Indian Generic Drugs Will Make Their Way to the U.S. (WSJ)

US: Medical Devices

  • Nearly 60% of Firms with 510(k) Submissions Got FDA's Refuse-to-Accept Letters in 2013 (MDDI)
  • Weight loss: EnteroMedics has a June date with the FDA (Mass Device)
  • Conflict Minerals in Medical Devices: SEC Reporting Update (Inside Medical Devices)
  • Medical devices high on $9B list of wasteful Medicare spending (Mass Device)
  • Guided Therapeutics Set to File Amended PMA Application for LuViva Advanced Cervical Scan After Meeting with FDA (Press)

US: Dietary Supplements

  • Q&A with NPA's New CEO, Daniel Fabricant, Ph.D. (Whole Foods)
  • NPA Dusts Off DSHEA Coalition To Expand Industry's Political Clout (Tan Sheet-$)

US: Assorted And Government

  • Artifacts Tell the Story of Our Culture and FDA's History (FDA)

Europe

  • Firms May Lose Data Exclusivity Earlier Under Planned EU Adaptive Licensing Regime (Pink Sheet-$)
  • NICE: Drug development costs should be more transparent (OnMedica)
  • When measuring European regulatory approval, the timestamp matters (PharmaPhorum)
  • NICE won't back early use of Zytiga in prostate cancer (PMLive) (Reuters) (Pharma Times) (Pharmafile) (SCRIP-$) (BioCentury)
  • Stakeholders decry EU pediatric plan timing & class waiver system (SCRIP-$)
  • BfArM: Production of Active Substances should partially be brought back home from Asia (ECA)
  • Drugmakers sign pledge on animal research transparency (Pharma Times)
  • The PPRS - new UK medicines pricing system reviewed (PharmaPhorum)
  • A Bad Debt That Will Shake Big Data (Harvard BOH)
  • Questions and answers on the withdrawal of the 'Guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A)' (EMA)

India

  • Ambiguities dot India's proposed SAE compensation norms (SCRIP-$)
  • Track & trace system for domestic drug supply chain likely to be ready in nine months (PharmaBiz)

Japan & China

Other International

  • BSI Update on ISO 13485:201X - 3rd Revision (Eisner) (BSI)
  • Biolyse vs. Health Canada: Battle brewing after cancer drug maker's license suspended (Canada.com) (Globe and Mail)
  • Vertex's Kalydeco, Approved by Health Canada, Not Available due to Lack of Funding (Global News)
  • Health Canada: DuPont Packaging Material Changes to Impact Sterile Medical Device Manufacturers (Emergo)

General Regulatory And Interesting Articles

  • Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Review (PLoS)
  • The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example. (PubMed)
  • Should you trust the latest health news? Here's how to tell. (Vox)

Regulatory Reconnaissance #318 - 14 May 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.

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.

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


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