Regulatory Reconnaissance: GSK’s Regulatory Troubles and a Sex Tape (30 June 2014)

Posted 30 June 2014 | By Alexander Gaffney, RAC 

Regulatory Reconnaissance: GSK’s Regulatory Troubles and a Sex Tape (30 June 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is on “vacation” this week. Regulatory Reconnaissance will continue as scheduled, but all other news is on hold until 7 July 2014.

In Focus: US

In Focus: International

  • Report: Sex Tape Led to GSK Pharma Fraud Investigation in China ( Pharma Times) ( FT-$) ( Guardian) ( Pharmafile) ( Bloomberg)
  • European Medicines Agency releases revised guidance on advanced-therapy classification for public consultation ( EMA) ( Guidance)
  • Novartis pulls EMA application for expanded Tasigna use ( PMLive) ( SCRIP-$)
  • India Considers Different Regulation Policies For APIs, Other drugs ( PharmAsia-$)
  • Indian Parliament to Consider New Biologics Regulator ( PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • Third time lucky as MannKind's inhaled insulin is approved ( PMLIve) ( Fierce) ( BioWorld) ( Pharmalot) ( Pink Sheet-$) ( NYT) ( Pharma Times) ( BioCentury) ( SCRIP-$) ( Burrill Report) ( FDA) ( Pharmafile)
  • FDA’s New Interpretation of GDUFA: It Depends Upon What the Meaning of the Word “New” Is ( FDA Law Blog)
  • A Review of FDA Warning Letters and Notices of Violation Issued for Patient-Reported Outcomes Promotional Claims between 2006 and 2012 ( PubMed)
  • Risk Evaluation and Mitigation Strategy (REMS) in Oncology from 2008 to Date ( Reuters)
  • TEAs Fail To Sweeten OTC Monograph Process, Brew Trouble For New Ingredients ( Tan Sheet-$)
  • Did FDA Make the Wrong Call on Ranbaxy and Generic Diovan? ( Pharmalot)
  • Allergan says U.S. FDA sent 2nd letter on acute migraine treatment ( Reuters)
  • “Right to Try” Bill Introduced in New Jersey ( Scout)
  • Ranbaxy To Launch Valsartan Week Of July 7, The Wait Is For Nexium And Valcyte ( PharmAsia-$)
  • ANDA Avalanche: How Will FDA Deal With The 600 Received This Month? ( Pink Sheet-$)
  • Risk-Based Quality Assessment Growing Among ANDA Chemistry Reviews ( Pink Sheet-$)
  • AstraZeneca Takes “Anti-Avastin” Pledge On Accelerated Approval Withdrawal ( Pink Sheet-$)
  • A Shift In Thinking: FDA Moves Toward Easier Neurofibromatosis Endpoints ( Pink Sheet-$)
  • Throckmorton on the Regulation of Opioids ( DrugWonks)
  • U.S. appeals court blocks lawsuits over Darvon, Darvocet painkillers ( Reuters) ( Scout)
  • MA Lawmakers unveil compounding pharmacy bill ( AP)
  • Flamel Technologies Announces FDA Approval of VAZCULEP ( Press)
  • FDA Approves Updated Labeling for Gattex® for Injection to Include Long-Term Data ( PharmPro) ( Press)

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

  • Lundbeck's desmoteplase flunks phase III stroke trial ( PMLive) ( BioCentury) ( SCRIP-$) ( Pharma Times)
  • Arzerra misses in Phase III bulky fludarabine-refractory CLL ( BioCentury)
  • GSK and Genmab’s ofatumumab disappoints in Ph III CLL study ( Pharma Letter-$) ( Press) ( SCRIP-$)
  • Merck nausea drug works in children in late-stage trial ( Reuters) ( Press)
  • Retrophin slips on liver woes in rare disease drug's first trial ( Fierce)
  • InDex's Kappaproct misses primary endpoint in UC trial ( BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • DSCSA: Congress Should Have Mandated Randomization ( RxTrace)
  • Pfizer and J&J Give Each Other Headaches Over an Advil Ad ( Pharmalot)
  • SCRIP US Capitol Capsule ( SCRIP-$)

US: Medical Devices

  • FDA guidance on MDDS raises concerns ( mHealth News)
  • FDA: We like innovation. Just don't mess it up ( Modern Healthcare)
  • 23andMe and FDA find a way to work together in shifting political atmosphere ( MedCity News)
  • 23andMe Customers Ordered To Arbitrate False Ad Claims ( Law 360-$)
  • Siemens seeks FDA approval for next-gen mammograms with tomosynthesis ( Mass Device) ( Press)
  • Class 1 Recall for Medtronic’s Duet External Drainage and Monitoring System ( FDA)
  • Tracking a Medical Device Recall Is No Easy Feat ( Medical Design)
  • WLF: Obama Sides with Plaintiffs’ Bar on Medical Device Preemption ( MDDI)
  • NIH keeps Corgenix Ebola Dx project running with new funding ( Fierce)
  • Encision gets caught in surgical mesh crossfire ( Mass Device)
  • FDA clears Encision’s burn protection system for minimally invasive surgeries ( MedCity News) ( Mass Device)
  • Thermedx Receives FDA 510(k) for Arthroscopy and Hysteroscopy Fluid Warming ( Press)
  • Thoratec launches HeartMate III trial ( Mass Device)

US: Dietary Supplements

  • Pay Now For Better Supplement Industry Enforcement, Or Foot Higher Bill Later ( Tan Sheet-$)
  • Artful Approach Improves NDI Notifications’ Chances At FDA ( Tan Sheet-$)
  • Legally Marketing Researched Supplements ( NPI)

US: Assorted And Government

  • CBO Scores DEA Regulation Bill ( CBO)
  • Prospect For FDA Funding Hike Dims As Appropriations Process Breaks Down, Advocates Say ( IHP-$)
  • Very Real Differences in Proposals for FDA’s FY 15 Budget ( Strengthen FDA)
  • FDA’s FY 16 Budget Already on the Table ( Strengthen FDA)
  • Supreme Court poised to rule on O-Care’s ‘birth control mandate’ ( The Hill)


  • European Medicines Agency releases revised guidance on advanced-therapy classification for public consultation ( EMA) ( Guidance)
  • Novartis pulls EMA application for expanded Tasigna use ( PMLive) ( SCRIP-$)
  • Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses ( EMA)
  • Questions and answers on benzalkonium chloride in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use ( EMA)
  • 149th Session of the European Pharmacopoeia Commission ( EDQM)
  • MSD’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma ( Press)
  • pSivida Corp. Reports Positive Regulatory Outcome for ILUVIEN; Moves to National Phase for Marketing Authorizations in 10 More EU Countries ( Press)


  • India Considers Different Regulation Policies For APIs, Other drugs ( PharmAsia-$)
  • Tit For Tat: A Match For PhRMA Takes Shape To Bat For Indian Generics In U.S. ( PharmAsia-$)
  • US pharma companies want dialogue with India on intellectual property rights ( India Times)
  • As Parliament begins on July 7, several Bills on health & pharma waiting for nod ( PharmaBiz)

Japan & China

Other International

  • Nigeria extends deadline for implementation of National Drug Distribution Guidelines ( PharmAfrica)
  • Australia: Summary of fees and charges at 1 July 2014 ( TGA)

Clinical Trials

  • BioCentury TV Explores Ways to Make Clinical Trials Smarter ( BCTV)
  • Teens miss out on clinical trials due to age limits ( OnMedica)

General Regulatory And Interesting Articles

  • Psychotropic Drugs Affect Men and Women Differently ( SciAm)

Regulatory Reconnaissance #347 – 30 June 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.

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