Regulatory Focus™ > News Articles > Regulatory Recon: GSK Under Investigation for Fraud (28 May 2014)

Regulatory Recon: GSK Under Investigation for Fraud (28 May 2014)

Posted 28 May 2014 | By Alexander Gaffney, RAC

Regulatory Recon: GSK Under Investigation for Fraud (28 May 2014)

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

  • Hyman Phelps Rips FDA Over Ranbaxy Exclusivity (Law 360-$) (HPM)
  • Sanofi, Lilly pursue Cialis over-the-counter approval (Reuters) (WSJ-$) (Lilly)
  • Review of Blood product recalls in the United States (PubMed)
  • Medtronic slips 'death penalty' sanctions in pain pump death suit (Mass Device)
  • Johnson & Johnson commits to $2.5B DePuy ASR settlement deal (Mass Device)
  • Current challenges for clinical trials of cardiovascular medical devices. (PubMed)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Hyman Phelps Rips FDA Over Ranbaxy Exclusivity (Law 360-$) (HPM)
  • Sanofi, Lilly pursue Cialis over-the-counter approval (Reuters) (WSJ-$) (Lilly)
  • FDA Almost Ready To Close Door On Rx Versions Of MiraLAX (Tan Sheet-$)
  • Woodcock on the Role of CDER in Biomedical Innovation (FasterCures)
  • Provectus crumbles on FDA 'breakthrough' rejection (SCRIP-$)
  • Ensuring Patient Access and Effective Drug Enforcement Act (House)
  • Review of Blood product recalls in the United States (PubMed)
  • Report: FDA approves many drugs that predictably increase heart and stroke risk (Press)
  • J&J Hit With Class Action Over Listerine False Labels (Law 360-$)
  • Lupus Therapies Continue to Evolve (FDA)

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

  • Advaxis Osteosarcoma Immunotherapy Granted Orphan Drug Status (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Medtronic slips 'death penalty' sanctions in pain pump death suit (Mass Device)
  • Johnson & Johnson commits to $2.5B DePuy ASR settlement deal (Mass Device)
  • Current challenges for clinical trials of cardiovascular medical devices. (PubMed)
  • Paragonix Technologies Inc., Announces Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Paragonix Sherpa Pak Kidney Transport System (Press)
  • FDA Clears InToneMV for the Non-Surgical Treatment of Male Urinary and Fecal Incontinence (Press)
  • Sonendo Receives 510(k) FDA Clearance For Its Multisonic Ultracleaning System (Press)
  • CMS Proposes Expanding Prior-Authorization Requirements (Gray Sheet-$)

US: Assorted And Government

  • Federal pain research database launched (NIH)
  • Obama picks HUD's Donovan to lead OMB (Federal Times)
  • Bill would give feds 3.3 percent pay raise in 2015 (Federal Times)
  • OIG Releases Spring Semiannual Report Highlighting Major Program Integrity Efforts (Reed Smith)

Europe

  • Europe approves Takeda drug for ulcerative colitis, Crohn's disease (Reuters) (Pharma Letter-$) (BioCentury) (Pharma Times) (PharmaPhorum) (Guardian)
  • Look, But Don't Use: European Medicines Agency Clinical Trial Data Terms Are Pointless (Science20) (Press)
  • GlaxoSmithKline Under Investigation by Serious Fraud Office (NYT) (Pharmafile) (Pharma Letter-$) (SCRIP-$) (Law 360-$) (GSK)
  • NICE yes for Genzyme's Lemtrada, but no for Janssen's Stelara (Pharma Times) (Press)
  • IQWIG finds added benefit in adult patients for VIIV Healthcare’s Tivicay (Pharma Letter-$)
  • EU Parliament election results: who will be next rapporteur for medtech file? (Clinica-$)
  • French Sunshine Act: Public Database Published (Policy and Medicine)
  • Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics (EMA)
  • Why Medicine Is Cheaper in Germany (The Atlantic)
  • European Medicines Agency closed 29-30 May 2014 (EMA)

India

  • Experts call for amendment in D&C Act to make pharma graduates mandatory for technical jobs in pharma cos (PharmaBiz)
  • Expert Panel to Assess 15 FDCs (PharmaBiz)
  • AIDCOC wants Centre to take stringent measures to strengthen regulatory mechanism in states (PharmaBiz)

Canada

  • Adverse Event Reporting Bill Stalls in Canadian Legislature (The Star)
  • Canada Approves Janssen's Novel Diabetes Treatment (DD&D)

Other International

  • Australia launches new portal to distribute information on medicines shortages (Pharma Letter-$)
  • Despite drawbacks, BRIC countries attractive for trials (Pharma Times)

General Regulatory And Interesting Articles

  • Wikipedia Highly Inaccurate When it Comes to Medical Advice (HuffPo)
  • The Role of Open Access in Reducing Waste in Medical Research (PLoS)

Regulatory Reconnaissance #326 – 28 May 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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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