Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 December 2013)

Regulatory Reconnaissance (6 December 2013)

Posted 06 December 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 raises PML concerns with Takeda's colitis, Crohn's drug vedolizumab (SCRIP-$) (BioCentury) (Pink Sheet-$) (Reuters) (Fierce)
  • AllTrials: Pfizer, Industry's Clinical Data Sharing Plans Have Off-Label Study Loopholes (AllTrials)
  • Government Files Statement of Interest Distinguishing Caronia in Off-Label Promotion False Claims Act Case (Jones Day)
  • Genetic Tester 23andMe to Stop Providing Data on Health Risks (NYTimes) (WSJ-$) (Forbes) (Press)
  • How A Recalled Medical Device Killed A Vet At Seattle's VA Hospital (KUOW)
  • PhRMA, BIO shun House-passed patent bill (SCRIP-$) (BioCentury) (Pink Sheet-$)

In Focus: International

  • European drug trial secrecy case hit by delay (Reuters) (Pharmafile) (PMLive) (BioCentury) (SCRIP-$)
  • New EU laws could halt life-saving research (OnMedica)
  • PMDA Sends Out Notice Regarding GMP Inspection To Confirm Manufacturing Process (PharmAsia-$)
  • Brazil's regulatory processes impair the growth of pharma industry (Pharma Letter-$)
  • EU agency starts in-depth review of Ariad leukaemia drug (Reuters) (EMA)

US: Pharmaceuticals/Biotechnology

  • AllTrials: Pfizer, Industry's Clinical Data Sharing Plans Have Off-Label Study Loopholes (AllTrials)
  • Government Files Statement of Interest Distinguishing Caronia in Off-Label Promotion False Claims Act Case (Jones Day)
  • Reckitt Benckiser Pharma Unit In The US Is Raided By The Feds (Pharmalot)
  • Opinion: FDA's Disrespect for the First Amendment (and Federal Courts) Dips to a New Low (WLF)
  • Lilly depression drug fails late-stage trials (Reuters) (IBJ) (Press) (SCRIP-$) (Fierce) (Pharma Letter-$) (PMLive) (Pharma Times) (BioCentury)
  • FDA raises PML concerns with Takeda's colitis, Crohn's drug vedolizumab (SCRIP-$) (BioCentury) (Pink Sheet-$) (Reuters) (Fierce)
  • Novartis bone marrow cancer drug meets goal in late-stage study (Reuters) (Pharma Times)
  • Puma Biotech rockets on positive results with neratinib in I-SPY 2 TRIAL (Pharma Letter-$) (BioCentury)
  • Shire's new dry eye drug disappoints in pivotal trial (Reuters) (BioCentury)
  • The Hardship of GDUFA Facility Fees (Lachman)
  • FDA MAPP: Management of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee Proceedings (FDA)
  • Management of CDER Carcinogenicity Assessment Committee and Communication of Committee Proceedings (FDA)
  • Should Biosimilars Have Distinct INNs? (Drug Wonks)
  • DEA Moves Swiftly in Issuing Final Rule Placing FYCOMPA In Schedule III (FDA Law Blog)
  • Genocea brings 2nd vaccine to clinic to rival $4B-a-year Prevnar (BioFlash)
  • FD's Marciniak: "clinical trial system is broken" (BMJ)
  • Jubilant slumps 10% on FDA warning (SCRIP-$)
  • Pacira Pharmaceuticals, Inc. Announces Submission of Prior Approval Supplement for Additional Exparel Manufacturing Suite (Press)
  • Teva expects big things from improved drug programme (PMLive)
  • IOM: Human Gene Transfer No Longer Requires Additional Review (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Genetic Tester 23andMe to Stop Providing Data on Health Risks (NYTimes) (WSJ-$) (Forbes) (Press)
  • How A Recalled Medical Device Killed A Vet At Seattle's VA Hospital (KUOW)
  • What Really Drove 23andMe And The FDA Apart (Fast Company)
  • FDA's Culture Is Genetically Dominant Over 23andMe's Business Model (Xconomy)
  • Smith & Nephew victory: Federal judge throws out metal-hip lawsuit (Fierce)
  • Cardiac stents fall short versus surgery, drugs in 2 new JAMA studies (Fierce)
  • Cochlear Limited Receives FDA Clearance for Magnetic Bone Conduction Hearing Device (MedGadget)
  • FDA clears Android-based continuous ECG monitor (Mobi Health News)

US: Dietary Supplements

  • Is My New Dietary Ingredient Really New? (NPI)

US: Assorted And Government

  • PhRMA, BIO shun House-passed patent bill (SCRIP-$) (BioCentury) (Pink Sheet-$)
  • Innovation Act Passed By House -- A Closer Examination (Patent Docs)
  • FDA Enforcement Report - Week of December 4, 2013 (FDA)
  • Boehner: House is done next Friday (The Hill)

Upcoming Meetings And Events

  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 10-11 December: FTC Meeting on Biosimilars (FTC)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • Taiwan Orders Recall Of 33 Drugs By Four Makers For Mislabeling Issues (PharmAsia-$)
  • Jarvik Heart's Japan regulatory win gives Thoratec a new heart pump challenge (Fierce)
  • PMDA Sends Out Notice Regarding GMP Inspection To Confirm Manufacturing Process (PharmAsia-$)

Other International

  • New Spanish documentation requirements for Argentina (Mass Device)
  • Brazil's regulatory processes impair the growth of pharma industry (Pharma Letter-$)
  • The TPP negotiations could be a bitter pill to swallow for Australians (Guardian)

General Regulatory And Interesting Articles

  • Treating Allergies With Pills or Drops Instead of Shots (NYTimes)
  • HIV virus returns after cure hope rose (Boston Globe)
  • Antiviral Nasal Spray Reduces Duration of Common Cold (Press)
  • A new method of wirelessly recharging medical device batteries with ultrasound (MNT)
  • International study finds lower-dose IUDs are safe and effective (Press)
  • Prostate Cancer Study Finds Success With Drug Combo (WSJ-$)
  • Sharks Do Get Cancer: Tumor Found in Great White (Scientific American)

Regulatory Reconnaissance #216 - 6 December 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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