Regulatory Focus™ > News Articles > Regulatory Recon: BMJ Investigation Claims Pradaxa Data Withheld from Regulators (24 July 2014)

Regulatory Recon: BMJ Investigation Claims Pradaxa Data Withheld from Regulators (24 July 2014)

Posted 24 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: BMJ Investigation Claims Pradaxa Data Withheld from Regulators (24 July 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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In Focus: US

In Focus: International

  • SK seeks approval for world's first malaria vaccine (GSK) (Reuters) (Bloomberg)
  • Do Risk Management Schemes Influence HTAs? (Context Matters)
  • Plegridy Approved in EU for the Treatment of Multiple Sclerosis (Press)
  • Indian Medical devices exporters upset over harassment by regulatory officials at ports (PharmaBiz)
  • India Price Cuts May Cause Broad Fallout, Industry Warns (PharmAsia-$)
  • How a Jewish Doctor Duped the Nazis: The astonishing, untold story of the Buchenwald vaccine scam (Politico)

US: Pharmaceuticals and Biotechnology

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

  • UCB's brivaracetam meets in Phase III epilepsy trial (BioCentury) (SCRIP-$)
  • Humacyte Receives Fast Track Designation for HumaGraft for Vascular Access in Hemodialysis Program (Press)
  • Cystic Fibrosis Drug Combination May Be Counteracting Itself (CEN)

US: Pharmaceuticals and Biotechnology: General

  • How to Pay for the Next Sovaldi (NCPA)

US: Medical Devices

  • FDA Regulation of Mobile Health Technologies (NEJM)
  • Edwards Lifesciences CEO asks Congress for better device regulation (Fierce)
  • FDA Mobile Apps Loophole Hazardous For Healthcare (Information Week)
  • FDA warns CareFusion over modified devices, quality control (Mass Device)
  • Surgical Robot Fails to Show Advantages in Treating Bladder Cancer (WSJ-$) (Reuters)
  • FTC commissioner warns on mobile health-data gathering (Reuters)
  • Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system (Press)
  • Cynosure Receives Expanded FDA Clearance to Market PicoSure for Treatment of Acne Scars (Press)

US: Dietary Supplements

  • Supplement Company Hit Over Unapproved Claims (FDA) (NI-USA)

US: Assorted And Government

  • Invoking Anti-Fraud Law, Some Serial Whistleblowers Get Rich (WSJ-$)

Europe

  • GSK seeks approval for world's first malaria vaccine (GSK) (Reuters) (Bloomberg)
  • Do Risk Management Schemes Influence HTAs? (Context Matters)
  • PLEGRIDY (Peginterferon beta-1a) Approved in the European Union for the Treatment of Multiple Sclerosis (Press)
  • CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone (EMA)
  • European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia (Press)
  • Europe Moving To Restrict Sovaldi’s Indication To Curb Its Cost (Pink Sheet-$)
  • APPG warns of continued UK meds shortages (Pharma Times)
  • Sorin Group Announces CE Mark Approval for CROWN PRT Heart Valve (Press)

India

  • Indian Medical devices exporters upset over harassment by regulatory officials at ports (PharmaBiz)
  • India Price Cuts May Cause Broad Fallout, Industry Warns (PharmAsia-$)
  • Pharma cos refuse to cut prices of 108 products despite NPPA order on July 10 (PharmaBiz)
  • Health ministry bans manufacture, sale of controversial anti-depressant drug Deanxit (PharmaBiz)

Other International

  • Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries (Press)

Clinical Trials

  • When Should you Be Able to Subpoena Clinical Trial Data? “Clinical Trials and the Right to Remain Silent” in JAMA Internal Medicine (Harvard BOH)
  • Inadequacy of remote desktop interface for independent reanalysis of data from drug trials (BMJ)

General Regulatory And Interesting Articles

  • How a Jewish Doctor Duped the Nazis: The astonishing, untold story of the Buchenwald vaccine scam (Politico)
  • Acetaminophen No Better Than Placebo for Back Pain (NYTimes) (Reuters)

Regulatory Reconnaissance #364 – 24 July 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.

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.


Categories: Recon, Regulatory News

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