Regulatory Focus™ > News Articles > Regulatory Recon: Amarin, FDA Consider Settling Off-Label Promotion Case, Kim Kardashian Corrects In

Regulatory Recon: Amarin, FDA Consider Settling Off-Label Promotion Case, Kim Kardashian Corrects Instagram Ad (1 September 2015)

Posted 01 September 2015 | By Michael Mezher 

Regulatory Recon: Amarin, FDA Consider Settling Off-Label Promotion Case, Kim Kardashian Corrects Instagram Ad (1 September 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • EMA’s medical literature monitoring enters into full operation ( EMA)
  • Early access to medicines scheme (EAMS) scientific opinion: sacubitril/valsartan ( MHRA)
  • Europe’s biopharma industry files complaint against French law ( PharmaLetter-$)
  • Clarification of Dutch stance on biological and biosimilar medicines ( PharmaLetter-$)
  • EDQM releases new edition of Technical Guide for the Elaboration of Monographs ( EDQM)
  • India’s generic drug wars ( SciDevNet)
  • How faster USFDA nods will help Indian generic drug makers ( Economic Times)
  • ANVISA Formally Recognizes MDSAP Program for Foreign Quality System Audits ( Emergo)
  • 2015 APEC Health & Economy Ministerial Meeting Joint Statement ( APEC)
  • Saudi FDA Issues Guidance on Conducting Clinical Trials ( FDANews-$)

US: Pharmaceuticals and Biotechnology

  • Amarin, FDA Consider Settling Off-Label Promotion Case ( BioCentury) ( SCRIP-$) ( InsideHealthPolicy-$) ( FDA Law Blog) ( Drug and Device Law)
  • Kim Kardashian corrects her Instagram drug ad ( Washington Post) ( FiercePharmaMarketing)
  • Should riskier drugs be approved for lethal diseases? ( Washington Post)
  • Califf, Nissen, And Others Agree And Disagree About Regulatory Standards ( CardioBrief)
  • Precision medicine, linked to DNA, still too often misses ( Boston Globe)
  • Industry Questions FDA Authority to Enforce Quality Metrics Guidance ( FDANews-$)
  • USP Supports USAID-Funded Effort to Secure Global Health Supply Chain through Quality Assurance ( USP)
  • Priority Review Voucher Updates: Valuation, Eligibility, Reauthorization ( FDA Law Blog)
  • How Big Pharma Can Play To Win In US Biosimilars ( SCRIP-$)
  • Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales ( Outsourcing-Pharma)
  • Sandoz: Don't Block Zarxio Under Amgen-Created 'Emergency' ( SCRIP-$)
  • With ‘female Viagra’ coming, doctor offers five warning signs of bedroom heart trouble ( Washington Post)

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

  • Priority Review for Intercept's OCA in PBC ( BioCentury)
  • Trevena's TRV130 meets in Phase II pain trial ( BioCentury)
  • Bristol-Myers and AbbVie speed toward FDA approval with a 'breakthrough' cancer drug ( FierceBiotech)
  • New Analyses from the IMPROVE-IT Study with VYTORIN ( Press)
  • New Real-World Evidence Reaffirms Low Major Bleeding Rates for Bayer’s Xarelto ( Press)
  • PEGASUS-TIMI 54 sub-analysis shows importance of continuing treatment with BRILINTA beyond one year following a heart attack ( Press)
  • Bristol's Fibrotic Game Plan: Promedior Buy Hinges On Phase II Data ( SCRIP-$)
  • Trevena Announces Positive Results from Phase 2b Study of TRV130 in Acute Postoperative Pain ( Press)
  • Bayer Expands Finerenone Clinical Development Programme with Three Phase III Studies ( Press) ( FierceBiotech)
  • Mitralign Receives FDA Approval for Percutaneous Tricuspid Repair Early Feasibility Study ( Press)
  • US FDA Approves Initiation of ViroMed's VM202 for Phase III Clinical Study of Chronic Non-Healing Ischemic Diabetic Foot Ulcer ( Press)
  • US Food and Drug Administration Accepts for Priority Review the Biologics License Application for Empliciti ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Guidance for Industry ( FDA)
  • Progress seen In addressing US drug shortages, but challenges remain ( In-Pharma Technologist)
  • What Biopharma Should Know When Implementing A Compassionate Use Program ( Life Science Leader-$)

US: Medical Devices

  • openFDA Unveils Cache of Medical Device Data ( openFDA)
  • Precedent from Amarin's off-label promotion victory covers devices too ( FierceMedicalDevices)
  • NovaBone wins PMA for MacroForm bone repair device ( MassDevice)
  • Google Life Sciences to Partner with Sanofi on Diabetes Therapies and Monitors ( BioSpace)
  • ( MobiHealthNews) ( FierceMedicalDevices)
  • St. Jude reports strong U.S. clinical trial results for its leadless pacemaker ( FierceMedicalDevices)
  • Mitralign wins FDA nod for tricuspid valve feasibility trial (MassDevice)
  • Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle East Respiratory Syndrome Coronavirus ( FDA)
  • Knee and hip replacements increase heart attack risk briefly ( Reuters)
  • Mouth Guard Monitors Health Markers, Transmits Information Wirelessly To Smart Phone ( BioSpace)
  • Conducting a Well-Controlled Clinical Study When Clinical Data is Required ( imarc)
  • Surefire Medical Receives FDA Clearance for Precision Direct-to-Tumor Embolization Device ( Press)

US: Assorted and Government

  • 'Innovative' Value-Based Pricing Strategies: Biopharma's Savior? ( SCRIP-$)

Upcoming Meetings and Events

Europe

  • EMA’s medical literature monitoring enters into full operation ( EMA)
  • Early access to medicines scheme (EAMS) scientific opinion: sacubitril/valsartan ( MHRA)
  • Making Britain The "Fastest Place" For Pharma R&D Adoption ( Life Science Leader-$)
  • Europe’s biopharma industry files complaint against French law ( PharmaLetter-$)
  • Clarification of Dutch stance on biological and biosimilar medicines ( PharmaLetter-$)
  • Cerebrotech VIPS Intracranial Fluid Detector Approved in EU ( medGadget)
  • Roche wins first approval for skin cancer drug Cotellic ( PMLive)
  • EDQM releases new edition of Technical Guide for the Elaboration of Monographs ( EDQM)
  • Two treatments developed by ultra-rare disease specialists Alexion Pharmaceuticals are now approved for use in Europe ( Pharmafile)

India

  • India’s generic drug wars ( SciDevNet)
  • How faster USFDA nods will help Indian generic drug makers ( Economic Times)
  • This diagnostics lab in India has come up with a unique test to treat Septicemia ( Business Insider)
  • DoP in discussion with banks to generate dedicated funds for pharma sector ( PharmaBiz)

Japan

  • Zeltia says pharmaceutical council recommends approval of Yondelis in Japan ( Reuters)

Australia

  • Medical Devices Safety Update, Volume 3, Number 5, September 2015 ( TGA)

Other International

  • ANVISA Formally Recognizes MDSAP Program for Foreign Quality System Audits ( Emergo)
  • 2015 APEC Health & Economy Ministerial Meeting Joint Statement ( APEC)
  • Ascletis to start Phase II HCV trial in Taiwan ( BioCentury)
  • Saudi FDA Issues Guidance on Conducting Clinical Trials ( FDANews-$)

General Health and Other Interesting Articles

  • From science fiction to reality—the dawn of the biofabricator ( PhysOrg)
  • Supplements Don’t Fight Cognitive Decline, N.I.H. Study Says ( NYTimes)
  • Here’s what it takes to be the perfect poop donor ( Washington Post)
  • This drug is so valuable it has a CDC pager number — but it didn’t protect one Houston teen from a “brain-eating” amoeba ( Washington Post)

Regulatory Reconnaissance #630 – 1 September 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher 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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