Regulatory Recon: 21st Century Cures Struggles in the Senate (27 October 2015)

Posted 27 October 2015 By Zachary Brennan

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

In Focus: US

In Focus: International

  • GSK's Malaria Vaccine To Be Piloted In Sub-Saharan Africa (SCRIP-$)
  • Is England's Cancer Drugs Fund Beyond Fixing? (PharmaPhorum)
  • New EMA scheme to optimise development of priority medicines (EMA)
  • MSF urges Indian and African govts to maintain trade in affordable generic medicines (PharmaBiz)
  • Russia's clinical trial approvals 'on the increase' (Outsourcing-Pharma)
  • China to Reform Review and Approval Process for Drugs and Medical Devices (Harvard Bill of Health Blog)

US: Pharmaceuticals and Biotechnology

  • New benefits of old Alzheimer's drug discovered (Reuters) (PharmaTimes)
  • Do You Really Want to Be An Executive In An FDA-Regulated Company? (FDA Law Blog)
  • Exploratory cash for dementia (BioCentury)
  • Easing Cancer Chemotherapy Effects (JAMA)
  • Harvard Drug Pricing Video (Harvard)

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

  • Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints (Press)
  • Keytruda improves lung cancer survival in new study (PharmaTimes)
  • MyoKardia's $75M IPO pitch could be the next big test of biotech's meddle (FierceBiotech)
  • Bio Blast Pharma reports promising data on muscle wasting drug (Reuters) (Press)
  • Merck's star oncology drug posts mixed results in a lung cancer trial (FierceBiotech)
  • Novartis paying $390M to settle kickback charges of inducing specialty pharmacies to recommend its drugs (Press)
  • Pfizer reports Q3 results (Press)
  • Bristol-Myers Squibb reports Q3 results (Press)
  • GSK heart drug disappoints in study, shingles vaccine on track (Reuters) (Press)
  • Alexion sits on Strensiq nest egg (EP Vantage)
  • J&J Oncology Head Confident About Fast-Tracked Daratumumab's Chances (SCRIP-$)

  • US: Medical Devices
  • FDA Likely To Require Imaging Studies In Light Of TAVR Leaflet Findings (Gray Sheet-$)
  • Ex-Biomet sales rep alleges retaliatory firing for blowing the whistle (Mass Device)
  • Allergan Breast Implant Suit Can Be Amended, 9th Circ. Says (Law360-$)
  • An Arizona doctor’s perspective on Theranos (MedCity News)
  • Stryker CEO: With MAKO, Company Is "Not Concerned" About Competition (Med Device Online)
  • Philips Introduces Next-Gen Sleep Apnea Therapy System (Med Device Online)
  • Helius Medical raises $2m, looks for $10m more (Mass Device)
  • AV Medical wins FDA 510(k) for Chameleon balloon catheter (Mass Device)
  • Stanford scientists reveal artificial skin device for prosthetics (FierceMedicalDevices)

US: Assorted and Government

  • Federal Investigators Looking at Valeant’s Contact Lens Dealings (ProPublica) (Law360-$)
  • CMS Releases Snapshot Of 2016 Federally Facilitated Marketplace Premiums (Health Affairs Blog)
  • Our curious Medicare vaccine reimbursement system (Harvard Bill of Health blog)
  • SNBL USA Wins BARDA Contract for Chem and RadNuc Animal Model Development (Press)

Upcoming Meetings and Events              

Europe

  • Two day EMA workshop on ICH Q12 guideline to be broadcast live (EMA)
  • Defective Medicines Report Centre (DMRC): an overview of our work (MHRA)
  • CHMP October meeting gives recommendations for Pfizer and MSD (PMLive)

India

  • Health ministry to upgrade manpower and drug testing infrastructure across country (PharmaBiz)

Other International

  • Consultation on a revised edition of the Uniform Recall Procedure for Therapeutic Goods (TGA)
  • Turkey Cuts Hep A Vaccine Tenders Over Safety, Supply Worries (PharmAsia News)
  • Korean Stem Cell Ventures Pursuing Divergent R&D Strategies (PharmAsiaNews)

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? Send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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