Regulatory Recon: Amgen Cholesterol Drug Data Disappoints Investors; German Drugmaker Stada Stokes Private Equity Bidding War (17 March 2017)

Posted 17 March 2017 By Michael Mezher

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

In Focus: US

  • The FDA chief must not be a proxy for industry (Nature)
  • Farewell to drug regulation? Trump nominates a 'bona-fide pharma shill' to head the FDA (Los Angeles Times)
  • My daughter is fighting a rare disease. A 'streamlined' FDA won't help her (STAT)
  • U.S. Biosimilar Rollout Hasn't Been That Slow, Attorney Says (Bloomberg)
  • Science and medicine leaders say Trump budget would be dire for US (Washington Post)
  • Trump NIH Cuts Would Be 'Catastrophic Event,' Says Bush-Era NIH Chief (Forbes)
  • Trump and GOP Work to Win Repeal of Obama's Health Act (NYTimes)
  • Trump and Ryan: Health Bill May Test Marriage of Convenience (NYTimes)
  • AstraZeneca receives fresh blow to potassium drug (Reuters) (Pharmafile)
  • Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance (Focus)
  • Amgen to refund cholesterol drug if patients suffer heart attack (Financial Times) (Endpoints)
  • Amgen Drug Prevents Heart Attacks, Not Deaths, Disappointing Experts (Forbes) (NYTimes) (The Street) (KHN) (STAT) (NEJM)
  • Lessons from immuno-oncology: a new era for cancer nanomedicine? (Nature)
  • Market watch: Upcoming market catalysts in Q2 2017 (Nature)
  • Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs? (FDA Law Blog)
  • The claim that the medical-device tax led to the loss of 20,000 US jobs (Washington Post)
  • GAO: More Information Needed to Oversee Use of Medically Important Drugs in Food Animals (GAO)
  • Four former FDA commissioners urge Congress to reject importing drugs (STAT) (BioCentury)
  • FDA Adverse Events Database: Time to Worry? (Medpage)
  • Circassia strikes deal with AstraZeneca for respiratory drugs (Reuters)

In Focus: International

  • Stada: The Hottest Drugmaker You've Never Heard Of That Everyone Wants to Buy (Bloomberg 1, 2)
  • UN drugs body places fentanyl ingredients on control list (Reuters)
  • NICE agrees £20m cost ceiling for new drugs (PMLive)
  • Novartis and Alexion lead protests at NICE proposals (PharmaLetter-$)
  • Finland throws hat into ring to host EU drug agency after Brexit (Reuters)
  • Coffee Shop Meeting Inspires Novel Way to Kill Cancer (Bloomberg)
  • European Regulatory Roundup: EMA's PRAC Seeks to Suspend Four Imaging Agents (Focus)
  • MHRA Releases Recommendations for Leadless Pacemakers (Focus)
  • CDSCO recruits 147 inspectors to enhance compliance in mfg units (Pharmabiz)
  • Big Pharma CEOs Descend On China: What's The Likely Agenda? (SCRIP-$)
  • NICE set to reject Janssen's Darzalex for multiple myeloma (PharmaTimes)
  • Research paper slams DeepMind/Royal Free NHS Trusts data deal (PharmaTimes)
  • HIV/Aids drugs for developing world face threat of disruption (Financial Times)
  • Indian drugmakers face squeeze in U.S. healthcare market (Reuters)

US: Pharmaceuticals & Biotechnology

  • PDUFA VI: Pediatrics Group Seeks Earlier And Faster Studies (Pink Sheet-$)
  • Biogen swoops to appoint Ex-Roche Vice President (Pharmafile)
  • Zika Vaccines Might Be Approved By 2020 (Pink Sheet-$)
  • Strategies and challenges for the next generation of antibody–drug conjugates (Nature)
  • To cleave or not to cleave: therapeutic gene editing with and without programmable nucleases (Nature)
  • Over-The-Counter Birth Control Pills Would Be Safe For Teens, Researchers Say (NPR)
  • Glenmark Wins 'Milestone' US Nod For COPD Trial In Innovation Push (SCRIP-$)
  • Technology Gap Separates OTC Drug Firms From Self-Care Sales Growth (Pink Sheet-$)
  • Enhancing scientific acumen in the pharma boardroom (Pharmafile)

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

  • First dedicated outcome trials of empagliflozin in chronic heart failure initiated (Press)
  • Pharnext Announces Initiation of Phase 3 Extension Study PLEO-CMT-FU of PXT3003 for Treatment of Charcot-Marie-Tooth Disease Type 1A (Press)
  • AveXis SMA gene therapy advances toward pivotal trial (Fierce)
  • Asana BioSciences Announces FDA Acceptance of the IND Application for its Novel SYK-JAK Inhibitor for Evaluation in Atopic Dermatitis (Press)

US: Medical Devices

  • Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients (NEJM)
  • Can drones deliver emergency defibrillators? (Reuters)
  • Zimmer Biomet shoots for robot-assisted total knee release next year (MassDevice)
  • Experimental blood test could speed autism diagnosis: US study (Reuters)

US: Assorted & Government

  • 3 ways Trump's FDA nominee could reshape digital health (Fierce)
  • HHS Secretary Signals Opening for Anti-Vax Movement (Medpage)
  • How Ryancare `Age Tax' Punishes Older Americans (Forbes)
  • One Way To Force Down Drug Prices: Have The US Exercise Its Patent Rights (NPR)
  • Another Court Tackles Prescription Drug Design Defect (Drug & Device Law)
  • Solicitor General Urges Supreme Court to Reverse California's Ill-Conceived Version of "Specific Jurisdiction" (Drug & Device Law)
  • PTAB Life Sciences Report -- Part III (Patent Docs)
  • Ex-Novartis employee found not guilty of deceitful drug advertising (Pharmafile)
  • Roche, Pharmacies Reach $17M Deal Over Unwanted Faxes (Law360-$)
  • AstraZeneca, Zydus Reach Deal To End Nexium IP Suit (Law360-$)

Upcoming Meetings & Events

Europe

  • MHRA Posts Notice to Online Pharmacies (MHRA)
  • UK Weighs Making Anti-Marlaria Tables Available at Pharmacies (MHRA)
  • Myeloma UK launches 'world first' immunotherapy trial (PharmaTimes)
  • Boston Scientific touts U.K. nod for EnduraLife batteries (MassDevice)
  • Report: Increase in allergy auto-injector scripts, with little guidance on optimal use (MassDevice)

India

  • India's import of medical devices increased by 16.8 %, export by 25.7 % during 2012-16 (Pharmabiz)

Asia

  • Aging population, healthcare costs and generics the backdrop as Japanese pharma comes in focus (PharmaLetter-$)

General Health & Other Interesting Articles

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.

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