Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Endo Hit With New Warning Letter (17 April 2014)

Regulatory Reconnaissance: Endo Hit With New Warning Letter (17 April 2014)

Posted 17 April 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • Endo Hit With FDA Warning Over Vaginal Mesh Facility (Law 360-$)
  • Zohydro Decision: A Blow To State Encroachment On Federal Turf (Law 360-$)
  • Astellas to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine (DOJ) (SCRIP-$)
  • Cancer Doctors Plan to Compare Value of Expensive Drugs (Bloomberg)
  • Medtronic to Court: Many Patients Will Die Without CoreValve TAVR Device (MDDI)
  • FDA makes adverse drug event data public, but this health IT startup makes it useful (MedCity News)

In Focus: International

  • New kind of trial aims to speed cancer drug development (Reuters) (FT-$) (Pink Sheet-$) (Pharmafile) (Guardian) (SCRIP-$)
  • GlaxoSmithKline says it is investigating bribery claims in Jordan and Lebanon (Guardian) (Law 360-$) (GSK) (SCRIP-$)
  • Polish Prosecutors Charge 13 in Connection With Glaxo Bribe Probe (WSJ-$)
  • Adaptive Licensing: How it Impacts Pharma and the Patient (Eye for Pharma)
  • ABPI criticises Roche for withholding Tamiflu data from Cochrane reviewers (PJ Online)
  • FDA Regulatory Actions Hit Indian Pharma Sector Hard (India Times)

US: Pharmaceuticals/Biotechnology

  • Zohydro Decision: A Blow To State Encroachment On Federal Turf (Law 360-$)
  • Astellas to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine (DOJ) (SCRIP-$)
  • New report finds Bydureon safest of new class of diabetes drugs (Fierce)
  • NEJM Talks Regulatory Hurdles With Venture Capitalists (NEJM)
  • FDA Officials: Demographic Subgroup Labeling Could Be Challenging (IHP-$)
  • Boehringer lines up biosimilars of major drugs (PMLive)
  • Glenmark recalls 2,904 bottles of Rantidine tablets in US market (India Times)
  • FDA Proposed Revisions to Orphan Designation Form (FDA)
  • USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance (Patent Docs)

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

  • Baxter's latest bleeding drug hits the mark in PhIII (Fierce) (BioCentury) (SCRIP-$)
  • Dynavax initiates PhIII study it hopes will quell FDA's safety concerns (Fierce)
  • Orphan status for BI leukaemia drug in USA and EU (Pharma Times) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Cancer Doctors Plan to Compare Value of Expensive Drugs (Bloomberg)
  • Should drug firms make payments to doctors? (BBC)
  • Free Drug Samples Prompt Skin Doctors To Prescribe Costlier Meds (NPR)
  • Who Foots the Bill For Expired Medicine? One Proposal: Drug Makers (WSJ)
  • Prediction of 'another whole generation of addicts' in wake of Zohydro (BioFlash)
  • Pharmaceutical Groups Seek Delay of New Generic Drug Payment Rate (CA Healthline)
  • VA, California Panels Urge Costly Hepatitis C Drugs For Sickest Patients (KHN)

US: Medical Devices

  • Endo Hit With FDA Warning Over Vaginal Mesh Facility (Law 360-$)
  • Medtronic to Court: Many Patients Will Die Without CoreValve TAVR Device (MDDI)
  • GS1 Launches UDI Implementation Guide (GS1)
  • Spacelabs Healthcare Recalls Anesthesia Device Over Defective Software (FDA)
  • Prodigy Diabetes Care Moves Forward After FDA "Closes Out" Warning Letter (Press)
  • Breathe Technologies, Inc. Announces FDA Clearance For NIOV System For Use With Compressed Gas (Press)

US: Dietary Supplements

  • Supplement Safety Critic Cohen Suggests Stronger, Responsive AER System (Tan Sheet-$) (NEJM)

US: Assorted And Government

  • FDA makes adverse drug event data public, but this health IT startup makes it useful (MedCity News)
  • Whistleblower Lawsuits On The Rise (PharmaGossip)
  • FDA Wants New Tech to Help it Handle Criminal Investigations (FDA)
  • FDA Enforcement Report - Week of April 16, 2014 (FDA)

Europe

  • New kind of trial aims to speed cancer drug development (Reuters) (FT-$) (Pink Sheet-$) (Pharmafile) (Guardian) (SCRIP-$)
  • Polish Prosecutors Charge 13 in Connection With Glaxo Bribe Probe (WSJ-$)
  • Adaptive Licensing: How it Impacts Pharma and the Patient (Eye for Pharma)
  • MHRA business plan: new products, services, income streams (Pharma Times)
  • ABPI criticises Roche for withholding Tamiflu data from Cochrane reviewers (PJ Online)
  • UK industry/MHRA generics quality forum launches (Pharma Times)
  • NHS England to fund hepatitis C drug Sovaldi (Pharma Times) (Pharma Times)
  • Founder of scandal-hit drugmaker Servier dies at 92 (Reuters) (Bloomberg)
  • ZipLine Medical Receives CE Mark and Regulatory Approvals in Japan and South Korea for Zip Surgical Skin Closure, Begins International Distribution (Press)

India

  • FDA Regulatory Actions Hit Indian Pharma Sector Hard (India Times)
  • Novartis strikes against four more Indian Galvus copiers (SCRIP-$)

Japan & China

  • Needle-Like Item Found In Novartis Japan's Voltaren Suppository (PharmAsia-$)

Other International

  • GlaxoSmithKline says it is investigating bribery claims in Jordan and Lebanon (Guardian) (Law 360-$) (GSK) (SCRIP-$)

General Regulatory And Interesting Articles

  • Niche medicines make up over half of global research pipeline, reveals APBI (PJ Online)
  • Nasal Spray Holds Hope in Fighting Flu Epidemic (NYTimes)
  • Pill developed to fight measles passes key test in animals (Reuters) (Scientific American)
  • New type of barcode could make counterfeiters' lives more difficult (Press)

Regulatory Reconnaissance #300 - 17 April 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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