Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Long-Awaited Vertex Study Results Show Success (24 June 2014)

Regulatory Reconnaissance: Long-Awaited Vertex Study Results Show Success (24 June 2014)

Posted 24 June 2014 | By Alexander Gaffney, RAC

Regulatory Reconnaissance: Long-Awaited Vertex Study Results Show Success (24 June 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • With Recall of Metoprolol Succinate, Renewed Worries About Generics (NYT)
  • Vertex Pharma Cystic Fibrosis Combo Therapy Hits Key Endpoints in Two Pivotal Trials (The Street) (Fierce) (Forbes) (Press) (Bloomberg) (NYT)
  • Survey: Regulatory Seen By Some As ‘Necessary Evil’ And ‘Deterrent To Revenue’ (Silver Sheet-$)
  • FDA Analysis Shows Women Benefit More from Cardiac Resynchronization Therapy (JAMA) (AP)
  • Filling Information Gaps for Women in Medical Device Clinical Trials (FDA)
  • Clinical Trial Termination at a Glance: Prevalence and Causes (Reuters)

In Focus: International

  • Clinical trials in India: Modi govt plans to clip wings of drug regulator (Indian Express)
  • US company Abraxis BioSciences denied patent on anti-cancer drug (India Times)
  • India likely to extend price caps to more drugs (Reuters)
  • CFDA Shakes Up Leadership (PharmAsia-$)
  • NICE pricing reform 'not radical enough' says ABPI (SCRIP-$)
  • Australia: eCTD submission update (TGA)

US: Pharmaceuticals and Biotechnology

  • With Recall of Metoprolol Succinate, Renewed Worries About Generics ( NYT)
  • NIH, FDA seek solutions to bring antibacterial drugs to market ( BioCentury)
  • Avanir Sues Ranbaxy To Block Generic Nuedexta ( Law 360-$)
  • Using electronic health records to help advance drug development and safety monitoring ( FDA)
  • FDA Balks At Black Box Warnings On Cholesterol Drugs ( Law 360-$)
  • Pediatric Psychopharmacology: Food and Drug Administration Approval Through the Evidence Lens ( Child & Adolescent Psychology)
  • Can Cancer Patients Really Get 'Drunk' From Docetaxel? ( Forbes)
  • Counter: The FDA’s Antidepressant Warning Didn’t Really “Backfire” ( Discover)

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

  • Vertex Pharma Cystic Fibrosis Combo Therapy Hits Key Endpoints in Two Pivotal Trials ( The Street) ( Fierce) ( Forbes) ( Press) ( Bloomberg) ( NYT)
  • FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine ( Merck)
  • Forest planning Viibryd sNDA for GAD ( BioCentury) ( Press)
  • FDA lifts hold on Burzynski's antineoplastons program ( SCRIP-$) ( Press)
  • Ohr Pharma eye drug falls short in trial ( Reuters)

US: Pharmaceuticals and Biotechnology: General

  • NCATS in New Agreement With the University of Delaware ( NIH)
  • What Impact Will Hepatitis C Drugs Have on Medical Costs? ( Pharmalot)
  • Pharmaceutical Companies Accuse Hospitals Of Misusing Discounts ( NPR)

US: Medical Devices

  • Survey: Regulatory Seen By Some As ‘Necessary Evil’ And ‘Deterrent To Revenue’ ( Silver Sheet-$)
  • FDA Analysis Shows Women Benefit More from Cardiac Resynchronization Therapy ( JAMA) ( AP)
  • Filling Information Gaps for Women in Medical Device Clinical Trials ( FDA)
  • FDA: A new posture in digital health? ( Modern Healthcare)
  • Smith & Nephew halts U.S. Renasys sales amid FDA snafu ( Mass Device)
  • ConvaTec in FDA hotseat after patients death, injuries ( Mass Device)
  • Supreme Court refuses to hear Medtronic's pain pump lawsuit appeal ( Mass Device) ( Law 360-$)
  • Devon Medical Products Receives FDA 510(k) Clearance to Market its extriCARE 3600 High-Flow Negative Pressure Wound Therapy (NPWT) Pump and Foam Wound Dressing Kit ( Press)

US: Dietary Supplements

  • John Oliver Delivers Lengthy, Humorous Takedown of the Supplement Industry ( Digg)
  • Producer of tainted dietary supplements sentenced in federal court ( FDA)      

Europe

  • NICE pricing reform 'not radical enough' says ABPI ( SCRIP-$)
  • pSivida Announces ILUVIEN Receives Marketing Authorization in Italy for Treatment of Chronic Diabetic Macular Edema ( Press)

India

  • Clinical trials in India: Modi govt plans to clip wings of drug regulator ( Indian Express)
  • US company Abraxis BioSciences denied patent on anti-cancer drug ( India Times)
  • India likely to extend price caps to more drugs ( Reuters)
  • Pharmaceutical firms find it hard to exit essential drugs market ( India Times) ( PharmAsia-$)
  • Gelatin with high chromium content being imported from China, DCGI yet to ban it ( PharmaBiz)

Japan & China

  • CFDA Shakes Up Leadership ( PharmAsia-$)
  • NeuroMetrix Reports Japan Regulatory Approval for NC-stat DPNCheck ( Press)

Other International

  • Australia: eCTD submission update ( TGA)
  • Australia: Experts warn of spike in number of sudden or accidental deaths involving Xanax ( ABC)
  • Australian clinical trials decreasing despite Phase I rise ( Pharma Letter-$)
  • How Taiwan’s nimble regulatory system measures up against the EU ( Clinica-$)

Clinical Trials

  • Clinical Trial Termination at a Glance: Prevalence and Causes ( Reuters)
  • Ethics and Regulatory Complexities for Pragmatic Clinical Trials ( JAMA)
  • Are Prisoners unfairly excluded from general clinical research? ( MNT)
  • Bristol-Myers Squibb Expands Access to Clinical Trial Data Through Collaboration with Academic Research Institute ( Press)
  • Ohio Clinical Trials Collaborative Launches at BIO2014, Accelerating Pharmaceutical Innovation in Ohio ( Press)
  • Australian clinical trials decreasing despite Phase I rise ( Pharma Letter-$)

General Regulatory And Interesting Articles

  • An Ultra-Simple Tourniquet That’s Saving Soldiers’ Lives ( Wired)
  • Worldwide Prescription Drug Sales to Exceed Trillion Dollar Mark by 2020 ( Press)

Regulatory Reconnaissance #343 – 24 June 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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