Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 April 2013)

Regulatory Reconnaissance (5 April 2013)

Posted 05 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. The topic of the day seems to be data transparency, with Roche announcing that it will at long last release its Tamiflu data to researchers and an excellent article in the Financial Times exploring why EMA's transparency measures are making industry nervous.

In the US, AstraZeneca's PhIII candidate fostamatinib gets mixed results, FDA cracks down harder on compounding pharmacies, Mercks Suvorexant gets an AdComm date, Pfizer recalls a smelly drug, J&J wins a $482 million patent verdict, a St. Jude lawsuit could fundamentally alter protections for many device makers, FDA approves CryoLife's HeRO Graft device, and new data standards from HL7 are released by FDA.

Abroad, an Australian group wants the country to do away with incremental patent extensions, the heads of medicines agencies release a new eCTD pilot, India might require new warnings on antibiotics to cut down on drug resistance, Medtronic gets UK approval for its Sentrant, ABPI releases new data on pharmaceutical promotion, ten companies run afoul of the ABPI marketing code, and the UK's cancer drugs fund removes 65 drugs from its list of approved pharmaceuticals.

Plus: Larger patients create design challenges for medical devices, US officials are keeping a close eye on an emerging flu strain, and a rare disease search engine looks to assist with diagnosis.

Five in Focus

  1. Patient Advocates Hail an Emerging Era of Open Clinical Study Data, But Companies Fear its Effects (Financial Times)
  2. St. Jude Hit by Suits, Could Fundamentally Alter Protections for all Device Makers (WSJ)
  3. Meningitis Deaths Prompt FDA Crackdown on Drug Mixing (Bloomberg)
  4. After long fight, Roche to release all Tamiflu drug data (Reuters) (PMLive) (Pharma Times) (BMJ)
  5. J&J Wins Reversal of $482 Million Patent Verdict Over Stents (Bloomberg) (Mass Device) (WSJ)


  • Yervoy-Zelboraf combo trial stopped on toxicity worries (Fierce Pharma) (The Pink Sheet) ($)
  • Meningitis Deaths Prompt FDA Crackdown on Drug Mixing (Bloomberg)
  • Upcoming FDA Advisory Committee to Discuss NDA for Merck, Sharpe and Dohma's Suvorexant (FDA) (BioCentury)
  • Pfizer has another recall tied to smelly drugs (Fierce Pharma Manufacturing) (Letter)
  • Hadasit Bio obtains FDA orphan drug status (Med City News)
  • Mixed top-line results for AstraZeneca's RA drug candidate fostamatinib (Reuters) (The Pharma Letter) (AstraZeneca) (The Street) (RTT)
  • Drug shortages cause delays for patients, headaches for pharmacists (Med City News)
  • U.S. says following new bird flu closely, preparing vaccine (Reuters) (NYTimes) (SCRIP Intelligence)
  • Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice (FDA)
  • Adimmune, other vax makers alert to stealthy bird flu (Fierce Vaccines)
  • GlobeImmune Kicks Off Phase 2 Trial (Drug Discovery and Development)
  • Ariad CEO Strikes Back, Insists Leukemia Drug Is Fine (The Street)
  • Biogen Idec shares surge on positive multiple sclerosis drug data (Fierce Biotech)
  • InBrief: Can ePedigree Be Deferred Until Mid-2016? (RxTrace)
  • Liver Toxicity Halts Melanoma Study (Med Page Today)
  • Florida Senate committee passes biosimilar bill (DSN)
  • Dr. Reddy's launches generic osteoporosis drug (DSN) (The Pharma Letter) ($)
  • Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran (CardioBrief)
  • Bill Keating gives keynote at National Prescription Drug abuse Prevention Summit (Cape Cod Today)
  • Pharmaceutical Companies Need to Revamp YouTube Presences (FDA News)
  • Emcure Pharmaceuticals USA Inc. - Citizen Petition for Generic Benadryl (FDA Docket)
  • FDA Approves ANDAs for Sun Pharma's Eszopiclone, Myland's Acyclovir, ACS Dobfar SPA's Ampicillin Sodium (FDA)
Medical Devices
  • J&J Wins Reversal of $482 Million Patent Verdict Over Stents (Bloomberg) (Mass Device) (WSJ)
  • St. Jude Hit by Suits, Could Fundamentally Alter Protections for all Device Makers (WSJ)
  • Bausch + Lomb gets FDA date for eye implant (Fierce Medical Devices)
  • InVivo Therapeutics' spinal cord scaffold wins FDA nod (Mass Device)
  • CryoLife says FDA approves new HeRO graft (Bloomberg Businessweek) (BioSpectrum)
  • Navidea touts PhIII data on Lymphoseek for head and neck cancer (Fierce Medical Devices)
  • Dako gains FDA blessing for breast cancer antibody Dx agent (Fierce Medical Devices)
  • Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose (FDA)
  • FDA Calls for Comments on its Agreement for Shipment of Devices for Sterilization (FDA)
  • FDA Calls for Comments on its Decision to Allow Extensions for Unapproved Devices Intended for Export Only (FDA)
  • Larger U.S. patients means larger medical devices | On Call (Mass Device)
  • FDA Releases Updated Stability Data Standards from Health Level 7 (HL7) (FDA)
  • Compromise On "Pay For Delay"? Supreme Court Hunts for Middle Ground (RPM Report) ($)
  • FDA 101: Product Recalls (video) (FDA)
  • New website makes finding a clinical trial easier (Boston Globe) (Outsourcing Pharma)
  • Is Size the next big thing in epidemiology? (Mini-Sentinel / Journal of Epidemiology)
  • Meetings: 2013 Medical Countermeasures Initiative Regulatory Science Symposium (FDA)
  • 2013 PDA/FDA Joint Regulatory Conference: Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory Environment (FDA)
  • Meetings: Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Conference with Society of Clinical Research Associates (FDA)
  • Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food (FDA) (CPG)
  • Laboratory of DNA Viruses subject up upcoming FDA Advisory Committee Meeting (FDA)
  • FDA to hold meeting on the international cooperation on cosmetics (FDA)
  • Complex Structure Function Claims: A case study of inflammation claims (Natural Products Insider)
  • What We Learn From Clinical Trials (PhRMA)
  • Incremental Innovation in the Development of Biopharmaceuticals Part 2 (PhRMA)
  • Literature Review Approach "Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid"; Request for Information and Comments (NIH)
  • Court Cracks Down On Multiple Shareholder Derivative Suits (Washington Legal Foundation)
Government and Budget
  • Obama to propose changes to Medicare and Social Security in new budget (CNN) (NYTimes)
  • Sunstein's 'Simpler Government' Is Legally Suspect, Overly Secretive And Politically Unaccountable (Think Progress)
  • Reminder: President's FY2014 Budget Due out Around 8-10 April 2013
Meetings and Events This Week
  • 4 April 2013: Hamburg to Deliver Keynote to 2013 National Rx Drug Abuse Summit (NRxDA Summit)
  • 4 April 2013: NIH's Francis Collins to Appear on Stephen Colbert's 'The Colbert Report' (Colbert Nation) (Video)
  • 5 April 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Postponed)
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • After long fight, Roche to release all Tamiflu drug data (Reuters) (PMLive) (Pharma Times) (BMJ)
  • Technical validation of eCTD submissions for new MAAs in DCP - Start of pilot phase (voluntary) (CMDh)
  • New UK 5-year Antimicrobial Resistance Strategy and Action Plan is in development, expected to be published in the summer (UK GOV)
  • IP Australia Calls For End To Incremental Drug Patent Extensions (PharmAsia News) ($)
  • India Considers Requiring Anti-OTC Cautions On Antibiotics, TB Drugs (PharmAsia News) ($)
  • Japanese AIDS Vaccine Trials Start In Rwanda (PharmAsia News) ($)
  • TGA Consultation: Cetirizine: proposed advisory statements for medicines (TGA)
  • Medtronic lands U.K. approval, plans global launch for Sentrant introducer sheath (Mass Device) (Medtronic)
  • 'Excessive hospitality' lands ten pharma firms in hot water (Pharma Times)
  • Pharma paid UK healthcare professionals £40m in 2012 (PMLive) (ABPI)
  • UK's Cancer Drugs Fund: approved drugs culled (Pharma Times) (The Telegraph)

General Regulatory and Interesting Articles

  • Patient Advocates Hail an Emerging Era of Open Clinical Study Data, But Companies Fear its Effects (Financial Times)
  • World experts debate case for new bird flu vaccine (Reuters)
  • Deadly new bird flu vindicates controversial research (Reuters)
  • Bioethicist: Drug makers should focus on affordability, not preserving patents (NBC)
  • Scientists Develop Monkey Model to Study Novel Coronavirus Infection (Science Daily)
  • Innovative startup's rare disease search engine could accelerate diagnoses (Med City News)

Regulatory Reconnaissance #39 - 5 April 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.

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