Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves First Generic Abilify (29 April 2015)

Regulatory Recon: FDA Approves First Generic Abilify (29 April 2015)

Posted 29 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Approves First Generic Abilify (29 April 2015)

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

In Focus: US

In Focus: International

  • Indian Govt approves programme to safety of medical devices ( India Times)
  • India to strengthen health cooperation with SAARC partners ( PharmaBiz)
  • MHLW says PIC/S membership means high quality drugs will get to patients faster ( In-Pharma)
  • ICH Q3D Metal Impurity Risk Assessments Pose Challenges ( Gold Sheet-$)
  • Sanofi's diabetes drug Toujeo gets EU nod ( PharmaTimes) ( PMLive)
  • Pharmaceutical industry regulation undermines NICE drugs appraisal work ( OnMedica)

Take Your Regulatory Career to the Next Level With Executive Training

  • Now more than ever, senior regulatory professionals must bridge science, regulation, business and strategy. RAPS’ Executive Development Program at the Kellogg School of Management is the only program of its kind that caters exclusively to experienced regulatory professionals. It is an exceptional opportunity to strengthen your management and leadership skills over four intensive days in an intimate learning environment. Register for the Executive Development Program here.

US: Pharmaceuticals and Biotechnology

  • FDA approves first generic Abilify to treat mental illnesses ( FDA) ( Reuters) ( Fierce) ( Law 360-$) ( Press) ( SCRIP-$)
  • FDA bats down Merck's sugammadex in third rejection ( Fierce) ( Reuters)
  • Takeda Agrees to Settle ACTOS Product Liability Lawsuits and Claims ( Press) ( Fierce) ( NYTimes)
  • Industry Comments on Generic Drug Labeling Rule ( FDA)
  • FDA Wants Technology to Mine Adverse Event Reports from WHO ( FDA)
  • Surrogate Biomarkers Gaining Interest but Development Path Still Foggy ( Thomson Reuters)
  • FDA Aims for State of Quality with New Inspection Protocol Project ( Gold Sheet-$)
  • CDER "having desperate time" recruiting neurologists ( BioCentury)
  • FDA’s Patent And Exclusivity Team Aims To Ensure Timely First Generics ( Pink Sheet-$)
  • How BioMarin Chose the Name "Vimizim" for its Drug ( Fierce)
  • Upcoming FDA AdComm on variant Creutzfeldt-Jakob Disease ( FDA)
  • Drug-Induced liver injury: interactions between drug properties and host factors ( PubMed)
  • Identification of drug-induced toxicity biomarkers for treatment determination ( PubMed)
  • 'Right-to-Try' Bill Advances in California ( CA Healthline)
  • BIO Comes Out Against California Price Transparency Bill ( Press)
  • Texas cancer center guilty of selling foreign-made Avastin ( Fierce)
  • Nebraska Governor: Wait for FDA Action on Medical Marijuana ( AP)

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

  • US FDA Grants Priority Review for Potential New Indication for AstraZeneca's BRILINTA ( Press) ( Reuters)
  • FDA Accepts Biologics License Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment of MS ( Press)
  • Galapagos' arthritis drug shines in another PhIIb study as M&A rumors simmer ( Fierce)
  • Cerulean Announces Fast Track Designation Granted for CRLX101 in Metastatic Renal Cell Carcinoma ( Press)
  • Bio-Path Holdings Granted Orphan Drug Designation for Liposomal Grb-2 in Acute Myeloid Leukemia ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Q&A with Chris Garabedian, former CEO of Sarepta Therapeutics ( BioFlash) ( Transcript)
  • 2015 Prescription Drug Prices Jump Another 3.8% in Q1, According to Truveris National Drug Index ( Press)
  • US Supreme Court to Consider Challenge to Execution Drug ( AP)
  • Need for Speed Defines Hepatitis C Race for Gilead, Achillion ( Bloomberg)

US: Medical Devices

US: Dietary Supplements

US: Assorted And Government

  • Senator: FDA Must be Ready for the Medical Breakthroughs that are Coming ( Senate)
  • Draft of 21st Century Cures Act Coming Soon, but Challenges Hit Negotiations ( Politico) ( NIH)
  • 'Don't break what's working,' FDA's Woodcock urges Congress ( SCRIP-$) ( The Hill) ( Pink Sheet-$)
  • Senate to Hold Next Hearing on Precision Medicine in Early May 2015 ( Senate)
  • IOM to rebrand as National Academy of Medicine ( ModernHealthcare) ( IOM)
  • FDA Press Releases – 1st Quarter 2015 ( EyeOnFDA)

Upcoming Meetings and Events

Europe

  • Sanofi's diabetes drug Toujeo gets EU nod ( PharmaTimes) ( PMLive)
  • Pharmaceutical industry regulation undermines NICE drugs appraisal work ( OnMedica)
  • STENTYS’ Next-Generation of Self-Apposing Stent System Receives CE Marking Ahead of Plan ( Press)
  • Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Status from the EMA for Pancreatic Cancer ( Press)
  • Amarantus Granted European Union Orphan Drug Designation for MANF for the Treatment of Retinitis Pigmentosa ( Press)

India

  • Govt approves programme to safety of medical devices ( India Times)
  • AdvaMed: Looming Price Caps In India Detrimental To Patient Access ( PharmAsia-$)
  • India to strengthen health cooperation with SAARC partners ( PharmaBiz)
  • Guidelines for mfg & marketing of dietary supplements, nutraceuticals to be issued soon ( PharmaBiz)
  • AIMED, IMA sign MoU to promote domestic mfg & use of Indian medical devices ( PharmaBiz)
  • Expansion Plans Of Dept Of Pharmaceuticals May Have To Wait ( 24 Insight)

Canada

  • Thalidomide survivors say Health Canada can't provide details on support ( Toronto Sun)

Japan

  • MHLW says PIC/S membership means high quality drugs will get to patients faster ( In-Pharma)

Australia

  • Australian medtech firms get three months' breathing space on conformity assessment recertification ( SCRIP RA-$)

Other International

  • ICH Q3D Metal Impurity Risk Assessments Pose Challenges ( Gold Sheet-$)
  • WHO report finds systems to combat antibiotic resistance lacking ( WHO) ( Reuters)
  • Korea takes measures to fight counterfeit drugs ( BioSpectrum)

General Regulatory And Interesting Articles

  • Drug Testing, Now Without the Chimp ( Bloomberg)
  • As Celiac and Gluten Sensitivities Gain Prominence, Drug Companies Race to Find Treatments ( NYTimes)
  • The Big Battle Over A Little Device: The IUD ( National Journal)
  • Scientists race to beat mosquito resistance in fight against malaria ( Reuters)
  • U.S. officials predict a return of avian flu in the fall ( Reuters)

Regulatory Reconnaissance #546 – 14 April 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@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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe