Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Court Says GSK Liable for Safety of its Generic Competitors (17 March 201

Regulatory Reconnaissance: Court Says GSK Liable for Safety of its Generic Competitors (17 March 2014)

Posted 17 March 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • Court Rules GSK Liable for Injuries Suffered by Patient Who Took Generic Version of its Drug (Law 360-$)
  • CMC Reporting Changes Could Mean Fewer Supplements, But Bulkier Annual Reports (Pink Sheet-$)
  • Revised ANDA Checklist - The New Requirements Keep on Coming (Lachman)
  • FDA Launches Webpage for eSubmission Standards for Biological Products (FDA)
  • Wanted: Evenhanded FDA Enforcement on Preorders (MDDI)
  • Novel Materials In Devices May Require Additional Biocompatibility Testing (Gray Sheet-$)
  • Are Internal Compliance Investigations Privileged? D.C. District Court Rules No (GRE Law Blog)
  • Informa purges Elsevier unit staff in wake of buyout (Fierce)

In Focus: International

  • Boehringer's first cancer drug gains NICE yes (Pharmafile) (PMLive)
  • Italy prosecutors open probe against Roche, Novartis executives (Reuters)
  • Patented Drugs Cheaper In India, But Less Affordable, Study Says (India Times)
  • Drugs sold by company in the Indian market are safe: Ranbaxy (India Times)
  • CFDA Orders Surprise Inspections Of Capsule Makers After Bad Gel Found (PharmAsia-$)
  • Japan targets "faster than FDA" medtech approvals, but reimbursement issues remain (Clinica-$)

US: Pharmaceuticals/Biotechnology

  • Court Rules GSK Liable for Injuries Suffered by Patient Who Took Generic Version of its Drug (Law 360-$)
  • CMC Reporting Changes Could Mean Fewer Supplements, But Bulkier Annual Reports (Pink Sheet-$)
  • Revised ANDA Checklist - The New Requirements Keep on Coming (Lachman)
  • Novartis gave doctors thousands to prescribe pills, feds allege (Newsday)
  • FDA Launches Webpage for eSubmission Standards for Biological Products (FDA)
  • FDA Keeps Calcitonin Products On The Market But Narrows Osteoporosis Claim (Pink Sheet-$)
  • How FDA Plans To Stop Worrying And Love Globalization (Pink Sheet-$)
  • Former FDA Associate Commissioner Slams Legislators for Trying to Overturn Approval of Zohydro (DrugWonks)
  • FDA Sends Lettter to Hundreds of Antiseptic Drug Companies Seeking Labeling Changes (FDA)
  • Elizabeth Warren Questions FDA Rules for Limiting Antibiotics on Farms (Businessweek)
  • FDA Approves New Blood Clot Use for Eliquis (Press) (Pharma Times) (PMLive) (Pharma Letter-$) (SCRIP-$) (Forbes)
  • FDA Puchases $200k Genomic Information Management System (FDA)
  • FDA approves IV formulation of Merck's Noxafil (BioCentury) (Press) (SCRIP-$)
  • FDA meeting this week to discuss a new method for making borderline donor lungs acceptable for transplant (MedPage Today)
  • PhRMA, GPhA Submit Comments to FDA on Proposed Rule (Lachman) (Pink Sheet-$)
  • Shire Recalls Batch of Gaucher Disease Drug due to Particulate Matter (FDA) (PharmPro)
  • Forest Labs Hit With Suit Over Antidepressant Marketing (Law 360-$)

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

  • Amgen melanoma vaccine shrinks tumours (Pharmafile) (Fierce) (Pharma Times) (Reuters)
  • Novartis Plans to Submit NDA for Bexsero in 2Q 2014 (NBC)
  • Intercept scores a PhIII win for lead drug following Friday night frights (Fierce) (The Street) (Xconomy) (Reuters)
  • FDA Awards Fast Track Status to Edison Pharmaceuticals' EPI-743 for Friedreich's Ataxia (Press)
  • Medivir: New Phase III Data from Once-Daily Simeprevir Presented (Press)

US: Pharmaceuticals and Biotechnology: General

  • Informa purges Elsevier unit staff in wake of buyout (Fierce)
  • With protections set to lapse on advanced drugs, U.S. presses strict rules overseas (Washington Post) (SCRIP-$) (Pharma Letter-$)
  • Glaxo to Bring Doctors In-House as Educational Speakers (Bloomberg)
  • DSCSA: Transaction Information (RxTrace)
  • NIMH Rethinks Psychiatry Experiments (Scientific American)
  • NYTimes Editorial Board: How Much Should Hepatitis C Treatment Cost? (NYTimes)
  • Inside The Barely Legal World Of Designer Drugs (NPR)
  • Here Comes the Office of Export Enforcement! Are You Ready? (Pharma Compliance Monitor)
  • Gilead's hot-selling Sovaldi draws more patent attacks (Fierce) (The Street) (SCRIP-$)
  • Newsweek Understands Nothing About the Animal Rule or Emergency Use Authorizations (Newsweek)
  • Chimerix started the week as a punching bag, then pulls off a TKO (Fierce)

US: Medical Devices

  • Wanted: Evenhanded FDA Enforcement on Preorders (MDDI)
  • Novel Materials In Devices May Require Additional Biocompatibility Testing (Gray Sheet-$)
  • FDA panel recommends approval of Staar Surgical's novel eye implant (Mass Device)
  • Louis Jacques (ex-CMS) On Coverage, Evidence And IDEs (Gray Sheet-$)
  • FDA approves GenPrime's quick drug test for coke, speed, meth, barbiturates, THC (MedCity News)
  • LVAD Experts Respond To Thoratec HeartMate II Safety Alert (Gray Sheet-$)
  • Abbott Recalls Blood Glucose Monitor FreeStyle Devices (FDA)
  • Computer System Problems Lead to Recall for McKesson Anesthesia Care Device (FDA)
  • Unveiled emails raise eyebrows about J&J's ties to consulting docs (Mass Device)
  • Toshiba's CT Myocardial Perfusion Imaging Technology FDA Cleared (MedGadget)
  • eZono receives FDA 510(k) clearance for eZono 4000 tablet ultrasound system with eZGuide (Press)

US: Dietary Supplements

  • NAD Advertising Policy Purposefully Differs from FTC Legal Standards for Substantiation (FDA Law Blog)

US: Assorted And Government

  • Sunshine Data Could Fast-Track False Claims Act Cases - U.S. Prosecutors (Pink Sheet-$)
  • Are Internal Compliance Investigations Privileged? D.C. District Court Rules No (GRE Law Blog)
  • "Please Congress, We Want Some More!" (For FDA) (Strengthen FDA)
  • Senators introduce regenerative medicines bill (BioCentury)
  • SCRIP's US Capitol Capsule (SCRIP-$)

Europe

  • Boehringer's first cancer drug gains NICE yes (Pharmafile) (PMLive)
  • Italy prosecutors open probe against Roche, Novartis executives (Reuters)
  • Boston Scientific Announces CE Mark Approval and First Implants of Ingevity MRI Pacing Leads (Press)
  • Heart maker Carmat to wait before next transplant: founder (Reuters)
  • Update on the French Sunshine Rules (Inside Medical Devices)
  • Integrity Applications Receives CE Mark Approval for Six-Month Calibration Validity of GlucoTrack DF-F (Press)
  • BioCardia Receives CE Mark for Morph AccessPro Steerable Introducer (Press)

India

  • Patented Drugs Cheaper In India, But Less Affordable, Study Says (India Times)
  • Drugs sold by company in the Indian market are safe: Ranbaxy (India Times)
  • Doctors, pharmacists differ on their role in Pharmacovigilance Programme of India (PharmaBiz)

Japan & China

  • CFDA Orders Surprise Inspections Of Capsule Makers After Bad Gel Found (PharmAsia-$)
  • Japan targets "faster than FDA" medtech approvals, but reimbursement issues remain (Clinica-$)
  • China cracks down on bogus med tech websites (Fierce)
  • China FDA Issues Warning For Drugs Containing Hydroxyethyl For Patients With Severe Sepsis (PharmAsia-$)

Other International

  • Australia: Medtronic Warns About Implanted Stimulation Devices (TGA) (TGA)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #277 - 17 March 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.

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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