Regulatory Focus™ > News Articles > Regulatory Recon: Is FDA Hiding Scientific Fraud from the Public? (10 February 2015)

Regulatory Recon: Is FDA Hiding Scientific Fraud from the Public? (10 February 2015)

Posted 10 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Is FDA Hiding Scientific Fraud from the Public? (10 February 2015)

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

In Focus: US

  • The FDA doesn't tell you when it finds scientific fraud (The Verge) (Slate) (JAMA) (Reuters) (MNT)
  • Experts say industry interactions with US FDA improving (In-Pharma) (BIO)
  • Why the sum of 21st Century Cures draft provisions would paralyze FDA (BioCentury-$)
  • FDA clears system to reduce stroke risk during stent and angioplasty procedures (FDA) (MPR) (Press) (Fierce) (Gray Sheet-$) (Mass Device)
  • U.S. DOJ probes Olympus over kickbacks, false marketing claims (Fierce) (Mass Device)
  • Outgoing FDA Commissioner Margaret Hamburg discusses her tenure, accomplishments, concerns (BioCentury-$)
  • “21st Century Cures” By Year’s End? Its Backers Want More Ideas (Xconomy) (BIO)
  • High NDI failure rate putting more emphasis on GRAS status for new ingredients (NI-USA)

In Focus: International

  • Drug withdrawal delays are causing avoidable deaths, investigation finds (PharmJournal)
  • Medical group challenges Sovaldi's EU patent (PharmaPhorum) (PharmaTimes) (Reuters)
  • French health reform bill to address drug shortages, clinical trials (SCRIP-$)
  • Mylan confirms it is being sued by Bayer over Nexavar patent challenge (PharmaLetter-$)
  • China FDA orders respiratory API recalled after 'fur' like impurities found (Fierce)
  • Brazil Establishes Clinical Trial Review Times (FDAnews-$)

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US: Pharmaceuticals and Biotechnology

  • The FDA doesn't tell you when it finds scientific fraud (The Verge) (Slate) (JAMA) (Reuters) (MNT)
  • Experts say industry interactions with US FDA improving (In-Pharma) (BIO)
  • Why the sum of 21st Century Cures draft provisions would paralyze FDA (BioCentury-$)
  • Remicade Biosimilar Review: Where 351(k) Pathway Bumps Into Orphan Drug Rules (Pink Sheet-$)
  • The mysterious nicotine lozenge that ex-smokers are hoarding (Washington Post)
  • BIO Heaps Praise on Legislative Efforts (The Hill)
  • Flonase Allergy Relief Exclusivity Sliced Up By Label Carve-Out (Tan Sheet-$)
  • Proposed Rule to Save FDA Postage (Lachman)
  • FDA's Mini Sentinel Preparing Look at Gardasil (Mini-Sentinel)
  • 'Right to try' meds measure advances in Utah (SLT)
  • Oregon: Right to Try bill raises questions about safety, FDA (Statesman Journal)
  • Pet tear-stain removers still widely available despite FDA warnings (Fierce)
  • Pa. Judge Won't Strike $2M Actos Verdict Against Takeda (Law 360-$)
  • Sanofi-Aventis Hit With Class Suit Over Drug Sales Practices (Law 360-$)

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

  • Inspirion Delivery Technologies Announces FDA Acceptance of MorphaBond ER (morphine sulfate extended-release) New Drug Application; Its Investigational Abuse-Deterrent, Extended-Release Opioid (Press)
  • Investigators link Novartis' would-be cardio blockbuster to Alzheimer's risk (Fierce) (Forbes)
  • Takeda says its 'breakthrough' cancer drug came through in Phase III (Fierce) (Press)
  • FDA grants orphan drug status for AIT's high dose nitric oxide formulation to treat CF (PBR)
  • New wave of drugs poised to shake up glaucoma treatment (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • BIO: venture funding favors novel R&D (BioCentury) (SCRIP-$)
  • Big Pharma Faces Some Big Patent Losses, but Pipelines are Improving (Pharmalot)
  • New Report: Forecasts for Specialty Medicines Have Been Overstated (PhRMA)
  • Oklahoma Debates Use of Nitrogen Gas for Executions (NYTimes)

US: Medical Devices

  • FDA clears system to reduce stroke risk during stent and angioplasty procedures (FDA) (MPR) (Press) (Fierce) (Gray Sheet-$) (Mass Device)
  • U.S. DOJ probes Olympus over kickbacks, false marketing claims (Fierce) (Mass Device)
  • FDA Clears New 3-D-Printed Bone Device (TMD)
  • Agendia Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test (Press)
  • Nanotherapeutics Receives Expanded 510(K) Marketing Clearance From the FDA For NanoFUSE DBM (Press)
  • FDA Clears New Blood-Draw Technology from Velano Vascular Designed to Reduce Needle Exposures for Hospitalized Patients and Healthcare Providers (Press)
  • Dexcom CGM app will be ready when Apple Watch launches (MobiHealthNews)

US: Dietary Supplements

  • High NDI failure rate putting more emphasis on GRAS status for new ingredients (NI-USA)
  • Five Dietary Supplements Recalled Due to Hidden Drugs (MPR) (FDA)
  • Industry Demands NY AG to #ReleaseTheReport (NPI)

US: Assorted And Government

  • Outgoing FDA Commissioner Margaret Hamburg discusses her tenure, accomplishments, concerns (BioCentury-$)
  • “21st Century Cures” By Year’s End? Its Backers Want More Ideas (Xconomy) (BIO)
  • How FDA Commissioner Hamburg left behind a better FDA (BioCentury-$)
  • What the next FDA commissioner - whoever that is - is walking into (BioCentury-$)
  • Rep. DeGette predicts bipartisan 21st Century Cures bill (BioCentury)

Upcoming Meetings

Ebola Outbreak

  • The search for an Ebola cure is gearing up — but there may be too few patients. (Washington Post)
  • Persevering Past Roadblocks to Build a Promising Ebola Vaccine (AP)
  • Drug targeting ebola virus protein VP24 shows promise in monkeys (Press)

Europe

  • Drug withdrawal delays are causing avoidable deaths, investigation finds (PharmJournal)
  • Medical group challenges Sovaldi's EU patent (PharmaPhorum) (PharmaTimes) (Reuters)
  • French health reform bill to address drug shortages, clinical trials (SCRIP-$)
  • Celltrion To Launch Biosimilar Remicade in More European Countries (PharmAsia-$)
  • SMC no for Zytiga but four new meds are in (PharmaTimes)
  • SMC Gives Celgene's Abraxane a Position Recommendation (Press)
  • Scottish Medicines Consortium (SMC) recommends Bosulif (bosutinib) for the treatment of chronic myeloid leukaemia (Press)
  • CHMP issues positive opinion on new schedule for Sanofi Pasteur's Hexyon (PharmaLetter-$)

India

  • Mylan confirms it is being sued by Bayer over Nexavar patent challenge (PharmaLetter-$)
  • U.S.-India Strategic & Commercial Dialogue (Two-Four Insight)
  • India’s Drug Act aiding harmful combination drugs without clinical trials: Study (IndiaTV)

China

  • China FDA orders respiratory API recalled after 'fur' like impurities found (Fierce)

Canada

  • With its ban on assisted death lifted, will Canada become a ‘suicide tourism’ destination? (WashingtonPost)

Australia

  • Australia Alert Over Biomet M2a metal-on-metal total hip replacement implants (TGA)

Other International

  • Brazil Establishes Clinical Trial Review Times (FDAnews-$)

General Regulatory And Interesting Articles

  • Vaccines Are Profitable, So What? (The Atlantic)
  • Vaccines: Delays, Too, Pose Risks (WSJ-$)
  • STIs no more likely in girls after HPV jab (OnMedica)
  • Men with prostate trouble should avoid some cold medicines (Reuters)

Regulatory Reconnaissance #490 – 10 February 2015

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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