Regulatory Focus™ > News Articles > Regulatory Reconnaissance (30 October 2013)

Regulatory Reconnaissance (30 October 2013)

Posted 30 October 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

  • FDA Throws More Cold Water On Amarin's Hopes For Vascepa (Forbes) (SCRIP-$) (BioCentury)
  • Merck works toward bringing Zilmax back to the U.S., Canada market (Reuters)
  • FDA Lays out its Policy for Making Staff Available to the Media in a Citizen Petition Response (FDA)
  • FDA's Pazdur: FDA willing to take risks (BioCentury)
  • Medtronic's CoreValve to Skip FDA panel review on path to U.S. market (Reuters) (Mass Device) (Mass Device) (Gray Sheet-$)
  • Lawrence G. Foster Dies at 88; Helped Lead Tylenol Out of Cyanide Crisis (NYTimes)

In Focus: International

  • Neglected Diseases Still Are, Well, Neglected (NYTimes) (MNT) (BIO)
  • Indian Patent Office Rejects Sprycel Compulsory License Application (PharmAsia-$)
  • S Korean police net ring smuggling diet pills containing human flesh (Nutra Ingredients)
  • Proposed EU Data Protection Rules Give Patients New Data 'Erasing' Powers (FDA News-$) (Reed Smith)
  • UK health research body backs wider trial disclosure & access to patient data (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • FDA Throws More Cold Water On Amarin's Hopes For Vascepa (Forbes) (SCRIP-$) (BioCentury)
  • Merck works toward bringing Zilmax back to the U.S., Canada market (Reuters)
  • FDA Lays out its Policy for Making Staff Available to the Media in a Citizen Petition Response (FDA)
  • FDA's Pazdur: FDA willing to take risks (BioCentury)
  • Impax Laboratories and TOLMAR, Inc. Announce Final FDA Approval for Generic Solaraze Gel (Diclofenac Sodium-3%) (Press)
  • US orphan status for Pharmalink's Busulipo (Pharma Letter-$) (SCRIP-$) (DD&D)
  • FDA Therapeutic Area Standards Would Have To Clear Industry Testing (Pink Sheet-$)
  • Pfizer Initiates Phase III Trial For PCSK9; Raises Doubts About Regulatory Pathway (Pink Sheet-$)
  • U.S. FDA Grants Orphan Drug Designation for KaloBios' KB001-A in Treatment of Cystic Fibrosis Patients (Press)
  • FDA aims to train docs to spot misleading drug ads--and report them (Fierce)
  • Actavis seeks approval for generic acne drug (DSN)
  • Speakers at GPhA Fall Technical Workshop Warn that Firms Best Understand GDUFA Review Penalties (Lachman)
  • Merrimack cancer drug fails mid-stage study (Reuters)
  • FDA bans suck sales out of Ranbaxy, Wockhardt (Fierce)
  • MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA (Press)
  • CVM Clarifies Use of Melengestrol Acetate in Combination with Monensin and Tylosin, and with Monensin Alone, in Animal Feed (FDA)
  • RTI Surgical Announces Successful Resolution to FDA Warning Letter for Alachua, Fla. Facility (Press)
  • Probe into Questcor's promotional activities widens (SCRIP-$) (AP)
  • Lantheus reports Phase III data for imaging agent (BioCentury)
  • Incyte's JAK inhibitor effective in PhII arthritis; dosing uncertainties remain (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Top Court Looks at Law Curbing Drug-Induced Abortion (WSJ-$)

US: Medical Devices

  • Medtronic's CoreValve skips FDA panel review on path to U.S. market (Reuters) (Mass Device) (Mass Device) (Gray Sheet-$)
  • Medical Device Firm iTraumaCare Receives Expanded Indication from FDA for iTClamp Hemorrhage Control System (Press)
  • Takeaways From McPhee V. DePuy's Preemption Pronouncement (Law 360-$)
  • Consultants: Device Industry Should Adopt Patient-Centric Business Model (IHP-$)
  • Raumedic Announces FDA Clearance of Neurovent-PTO; a Multimodal Catheter for Monitoring of Brain Tissue pti02, ICP and ICT. (Press)

US: Dietary Supplements

US: Assorted And Government

  • Lawrence G. Foster Dies at 88; Helped Lead Tylenol Out of Cyanide Crisis (NYTimes)
  • NIH Chief: Get Ready for Testing Whole Genome (MedPage Today)
  • CMS Has Adjusted the Reporting Threshold for Payments or Other Transfers of Value Pursuant to the Sunshine Act (Porzio)

Upcoming Meetings And Events

  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 1 November 2013: Blood Products Advisory Committee Meeting  (FDA)
  • 4-5 November 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 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

  • Proposed EU Data Protection Rules Give Patients New Data 'Erasing' Powers (FDA News-$) (Reed Smith)
  • UK health research body backs wider trial disclosure & access to patient data (SCRIP-$)
  • New Marketing Authorisation Application Submitted to EMA for Ibrutinib for the Treatment of Two Forms of Blood Cancer (Press)
  • UK To Ban Hospitals' Use Of Many Metal Hip Implants (Law 360-$)
  • Workshop on the patient's voice in the evaluation of medicines (EMA)

Asia

  • Indian Patent Office Rejects Sprycel Compulsory License Application (PharmAsia-$)
  • S Korean police net ring smuggling diet pills containing human flesh (Nutra Ingredients)

Other International

  • Neglected Diseases Still Are, Well, Neglected (NYTimes) (MNT) (BIO)

General Regulatory And Interesting Articles

  • Vaccine Stability Improvements Sought By GSK, Sanofi And Gates Foundation (Pink Sheet-$) (BioCentury) (Fierce)
  • Study Shows Beta-Blockers Associated with Increase in Coronary Adverse Events (DSM)
  • Study: Flu Vaccines Containing Mercury Safe (Wiley)
  • Contributions of Robert T. O'Neill to the Evolution of Regulatory Statistical Science (Taylor Francis)
  • Statistical Considerations for Noninferiority Trial Designs Without Placebo (Taylor Francis)

Regulatory Reconnaissance #191 - 30 October 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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