Regulatory Focus™ > News Articles > Regulatory Recon: Trump Victory Boosts Pharma Stocks; Future of Obamacare Uncertain (9 November 2016

Regulatory Recon: Trump Victory Boosts Pharma Stocks Future of Obamacare Uncertain (9 November 2016)

Posted 09 November 2016 | By Michael Mezher 

Regulatory Recon: Trump Victory Boosts Pharma Stocks Future of Obamacare Uncertain (9 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Republican Donald Trump Is Elected President Of United States And Global Markets Plunge (Forbes) (Financial Times)
  • Drugmakers Jump as Trump Victory Eases Pricing Concern (Bloomberg) (Fierce) (PMLive) (Pink Sheet-$) (WSJ)
  • Trump win brings uncertainty to pharma (EPVantage)
  • Drug companies just scored a big election victory (Washington Post)
  • The Future of Obamacare Looks Bleak (NYTimes) (NPR) (Forbes)
  • Valeant's Struggles Are a Bad Omen for the Entire Industry (NYTimes)
  • California drug pricing initiative headed for defeat (Reuters)
  • AstraZeneca walks tightrope of drug trials (Financial Times)
  • Walgreen Sues Theranos, Seeks $140 Million in Damages (WSJ) (Reuters)
  • FDA Taken to Task for Handling of Opioid Crisis (Medpage)
  • U.S. watchdog told Medicare, Medicaid that EpiPen was misclassified in 2009: senator (Reuters)
  • Arrowhead sneaks out pre-election clinical hold news on Hep B candidate (Fierce) (Press)
  • FDA Warns Valeant Over Quality System Violations (Focus)
  • FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals (Focus)
  • Bone Therapeutics cans plan to trial cell therapy in US (Fierce)
  • For FDA, 'Screaming Unmet Need' For Antibiotics May Outweigh Significant Safety Concerns (KHN)
  • Novel Cholesterol Therapy Flops And Company Ends Development (CardioBrief)
  • Railroading at the FDA (Nature)

In Focus: International

  • EMA's Rasi on Brexit: Climate of Uncertainty Straining Worker Motivation (Focus)
  • Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (Focus)
  • European Drugs Companies Get An Injection From Trump Victory (The Street)
  • Pfizer to shut two out of three manufacturing plants in UK (Pharmafile) (PharmaTimes)
  • Japan OKs Medinol stent trial (MassDevice)
  • MP urges UK government to "listen to industry experts" on EMA post-Brexit (PharmaLetter-$)
  • NPPA seeks over Rs 1,000 crore from drug makers following SC win (Economic Times)
  • Andrew Witty leaves GSK with new challenges, robust pipeline (Economic Times)
  • Pig experiment may have exposed Canadian lab worker to Ebola (Reuters)
  • British AI group licenses Janssen drug candidates (PharmaTimes)
  • NICE rejects NHS funding for multiple myeloma drug Kyprolis (PharmaTimes) (PharmaLetter-$)
  • What Makes Asia Appealing For Clinical Trials? (SCRIP-$)

US: Pharmaceuticals & Biotechnology

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

  • FDA reviewing Emmaus' sickle cell therapy (BioCentury)
  • ARIAD Announces Phase 1/2 Trial Data on Investigational Drug Brigatinib Published in The Lancet Oncology (Press)
  • Hallux Announces Start of Phase 2 Clinical Trial (Press)
  • Alkermes Phase III study spell good news for major depressive disorder space, says analyst (PharmaLetter-$)
  • Bristol-Myers Squibb and Infinity Pharmaceuticals Announce Clinical Collaboration to Evaluate Opdivo (nivolumab) in Combination with IPI-549 in Advanced Solid Tumors (Press)

US: Medical Devices

  • Side Head Regulator TT Tablet by Life Rising/Ton Shen Health: Recall - Elevated Levels of Lead (FDA)
  • ECRI lists the top 10 medical device hazards (MassDevice)
  • Getting a pacemaker soon after heart valve replacement linked with worse outcomes (MNT)
  • Boston Scientific launches Dakota nitinol kidney stone retrieval device (MassDevice)
  • Baxter adds $1.5B to share buyback plan (MassDevice)
  • FDA Clearance for joimax® Vaporflex® and Legato® Electrosurgical Probes (Press)
  • Syneron Candela Announces FDA Clearance Of Profound™ SubQ To Improve The Appearance Of Cellulite, As Supported By Long Term Data (Press)

US: Assorted & Government

  • Smoking Out the Scope of Preemption (Drug and Device Law)
  • Mother Sentenced to 120 Months in Prison, Son Sentenced to 30 Months in Prison for Involvement in $9.5 Million Pharmacy Fraud (DoJ)
  • US amicus brief backs reversal of court opinion (PharmaLetter-$)
  • Appeals court reverses AngioScore win over TriReme (MassDevice)
  • Shareholders Sue Cempra Over Pneumonia Drug Safety (Law360-$)

Upcoming Meetings & Events

Europe

  • Rentschler ups capacity again, with second 2,000L single-use bioreactor (BioPharmaReporter)

India

Australia

  • Consultation: The regulatory framework for advertising therapeutic goods - November 2016 (TGA)
  • Medical devices post-market vigilance - statistics for 2015 (TGA)
  • Medicines and vaccines post-market vigilance - statistics for 2015 (TGA)

Zika

  • Could Zika Virus Have Lasting Impact on Male Fertility? (NIH)

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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