Regulatory Focus™ > News Articles > Regulatory Recon: Abuse-Deterrent Zohydro on its Way (3 July 2014)

Regulatory Recon: Abuse-Deterrent Zohydro on its Way (3 July 2014)

Posted 03 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Abuse-Deterrent Zohydro on its Way (3 July 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

  • Zogenix planning abuse-deterrent Zohydro sNDA ( BioCentury) ( Fierce) ( Pink Sheet-$) ( SCRIP-$) ( AP)
  • Groups call on FDA to protect patient safety, preserve INN for biosimilars ( MNT) ( WSJ-$)
  • Clinical Trial Transparency — Antidote to Weaker Off-Label-Promotion Rules? ( NEJM)
  • Center for Inquiry Chides FDA for Releasing Burzynski Clinical Hold ( CFI)
  • Lawmakers push FDA oversight of lab tests ( The Hill)
  • FDA reveals HeartWare warning letter ( Mass Device) ( Letter)
  • FDA warns Staar Surgical for missing documentation ( Mass Device)

In Focus: International

  • Health Canada to release side-effect data after probe ( The Star)
  • IMDRF Posts RPS Beta Testing Document ( IMDRF)
  • Taiwan TV Network Fined For Airing Pharma Ad As Rule Easement Mulled ( PharmAsia-$)
  • Compliance Issues To Focus On Vetting Employees In China After GSK Sex Tape Revelations ( PharmAsia-$)

US: Pharmaceuticals and Biotechnology

  • Zogenix planning abuse-deterrent Zohydro sNDA ( BioCentury) ( Fierce) ( Pink Sheet-$) ( SCRIP-$) ( AP)
  • Groups call on FDA to protect patient safety, preserve INN for biosimilars ( MNT) ( WSJ-$)
  • Clinical Trial Transparency — Antidote to Weaker Off-Label-Promotion Rules? ( NEJM)
  • Center for Inquiry Chides FDA for Releasing Burzynski Clinical Hold ( CFI)
  • Generics Inquiries ‘Lost in Translation’ ( Gold Sheet-$)
  • Petition calls on FDA to amend informed consent requirements ( Outsourcing Pharma) ( Law 360-$)
  • Januvia Linked To Increase in Heart Failure Hospitalizations ( Forbes)
  • Pfizer, Teva, Causch & Lomb all Hit by Class II Drug Recalls ( FDA)
  • Sun Pharma recalls 200 vials of cancer drug gemcitabine in US: FDA ( India Times)
  • Eagle Pharmaceuticals Receives Tentative Approval for Patented, Ready-to-Dilute Bendamustine Hydrochloride Injection NDA ( Press) ( MedCityNews)
  • Testosterone-Myocardial Infarction Link Questioned ( MedPage Today)
  • Compounders Can Relax, But Not Too Much ( FDA Law Blog) ( FDA Law Blog)
  • FDASIA Heightens Focus on Proactive Communications with FDA; Timeliness, Accuracy and Transparency are Key, GMP Compliance Experts Advise ( IPQ-$)
  • HHS to hold toxicology workshop ( BioCentury)
  • Anti-Infective Incentives: GAIN, LPAD Won’t Be Enough HHS-Commissioned Report Finds ( RPM Report-$)
  • Alternate Hatch-Waxman Strategies For Branded Pharma ( Law 360-$)

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

  • Akashi Therapeutics Receives Fast Track Designation for HT-100 from FDA for the Treatment of Duchenne Muscular Dystrophy ( Press)
  • Files Citizen Petition with the U.S. Food and Drug Administration (FDA) Regarding the Complexity of COPAXONE (glatiramer acetate) ( Press)
  • Priority Review for Boehringer's nintedanib ( BioCentury) ( Fierce) ( Press)
  • Race tight for genital herpes vaccine: Agenus, Genocea announce positive data ( MedCity News)
  • FDA Grants Orphan Designation to Galderma’s Skin Disease Drug ( Press)  ( Press)
  • Insys Cannabidiol Snags Orphan Designation for Rare Epilepsy ( Press)
  • Regado takes a beating as big PhIII study faces safety review ( Fierce)

US: Pharmaceuticals and Biotechnology: General

  • The Price of Vaccines is Skyrocketing ( NYTimes)
  • DEA Sets Proposed Production Quotas for Schedule I, II Substances ( DEA)
  • Pfizer Receives Kosher Certification for Gaucher Disease Drug ( Press)
  • Why Are Some States Prescribing So Many Painkillers? ( Forbes)

US: Medical Devices

  • Lawmakers push FDA oversight of lab tests ( The Hill)
  • FDA reveals HeartWare warning letter ( Mass Device) ( Letter)
  • FDA warns Staar Surgical for missing documentation ( Mass Device)
  • FDA Reclassifies Nonpowered Lower Extremity Pressure Wrap ( FDA)
  • FDA Reclassifies Transcutaneous Electrical Nerve Stimulator to Treat Headache ( FDA)
  • Medtronic issues Class I recall of Duet neuro drainage and monitoring systems ( Mass Device) ( FDA)
  • Preemption Questions Persist: Supreme Court Doesn’t Take Bait In Medtronic Case ( Gray Sheet-$)
  • Guided Therapeutics Anticipates July 2014 PMA Filing for its LuViva Advanced Cervical Scan ( Press)
  • FDA clears EarlySense’s vital sign monitoring chair sensor ( MobiHealthNews)

US: Dietary Supplements

  • Federal judge approves consent decree with New York dietary supplement maker ( FDA)
  • CRN joins with IADSA to broaden reach of supplement safety info ( NI-USA)

US: Assorted And Government

  • FDA Budget Issues Creep Into Strategic Priorities ( Pink Sheet-$)
  • Several Test Labs Awaiting Approval for AAMI ES 60601-1, ed. 3.1 under OSHA NRTL Program ( Eisner)

Europe

  • Eisai Receives European Commission Approval Of Indication Expansion For Anticancer Agent Halaven For Advanced Breast Cancer After Only One Prior Chemotherapy ( Press)
  • Drug groups welcome UK push to tackle superbugs ( FT-$)
  • Removal of an orphan designation ( EMA)
  • IEC 60601-1-12 Just Published – MEE & MES Intended for Use in Emergency Medical Services Environment ( Eisner)

Japan & China

  • Compliance Issues To Focus On Vetting Employees In China After GSK Sex Tape Revelations ( PharmAsia-$)

Other International

  • Health Canada to release side-effect data after probe ( The Star)
  • IMDRF Posts RPS Beta Testing Document ( IMDRF)
  • Upcoming IMDRF Meeting Details, Agenda Set ( FDA)
  • South Africa trade group intensifies efforts on generics access ( Pharma letter-$)
  • Australian Regulators Warn on High Revision Rates for Hip Replacement System ( TGA)
  • Taiwan TV Network Fined For Airing Pharma Ad As Rule Easement Mulled ( PharmAsia-$)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #350 – 3 July 2014

RegulatoryReconnaissance is our daily intelligence briefing for the regulatory affairsspace, bringing you the top regulatory news stories from around the globe. Eachweekday morning, we aim to bring you the latest highlights of new approvals,meetings, legal and political developments, regulations and guidance, and thelatest trends with the potential to impact regulatory affairs professionals andthe 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 ournext edition of Regulatory Reconnaissance. Want this in your inbox eachmorning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact theeditor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


Categories: Recon, Regulatory News

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