Regulatory Focus™ > News Articles > Regulatory Recon: Trump Meets With Silicon Valley Insiders for FDA Pick; Lilly Defeats Teva in Alimt

Regulatory Recon: Trump Meets With Silicon Valley Insiders for FDA Pick Lilly Defeats Teva in Alimta Patent Dispute (13 January 2017)

Posted 13 January 2017 | By Michael Mezher 

Regulatory Recon: Trump Meets With Silicon Valley Insiders for FDA Pick Lilly Defeats Teva in Alimta Patent Dispute (13 January 2017)

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

In Focus: US

  • Trump meets with tech leaders Srinivasan and O'Neill for FDA top job  (Fierce) (STAT) (The Hill) (CNBC)
  • Big Pharma on the Hot Seat (NYTimes)
  • US congressional committee demands answers on WHO cancer agency (Reuters)
  • Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance (Focus)
  • House Expected to Follow Senate's Lead on Rush to Repeal Health Law (NYTimes)
  • Pharma company executives debate drug pricing increases (Reuters)
  • Sanofi confident it can overturn Praluent patent ruling (Financial Times)
  • Eli Lilly defeats Teva appeal over Alimta cancer drug (Reuters) (The Street) (Pharmafile) (Press)
  • CVS slashes price of Impax's EpiPen rival (Reuters)
  • A Nevada woman dies of a superbug resistant to every available antibiotic in the US (STAT) (Medpage)
  • Trump's HHS Nominee Got A Sweetheart Deal From A Foreign Biotech Firm (KHN)
  • Senate reintroduces bill to repeal medical device tax (MassDevice) (Bill)
  • Sens. Reintroduce Bill Regulating Pay-For-Delay Deals (Law360-$) (Bill)
  • Questionable "Young Blood" Transfusions Offered in U.S. as Anti-Aging Remedy (MIT Technology Review)
  • Why Trump Faces Stiff Fight to Slash Drug Prices (Bloomberg)
  • Trump's Strategy for Cutting Drug Prices Is DOA (Bloomberg)
  • Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance (Focus)
  • 180-Day Exclusivity for Generics: FDA Releases Draft Guidance (Focus) (FDA Law Blog)
  • FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs (Focus)
  • FDA Offers Draft Guidance on New Pre-Request for Designation Process (Focus)
  • Trump vow on high drug prices taps into public anger (Financial Times)
  • Zimmer Biomet Holdings Inc. Agrees to Pay $17.4 Million to Resolve Foreign Corrupt Practices Act Charges (DoJ) (MassDevice)
  • Baxter to pay $18 million over mold at North Carolina plant (Reuters)
  • Novartis Resurrects Failed Muscle Wasting Drug In New Obesity Trial (SCRIP-$)

In Focus: International                                                         

  • Germany's Merck Taps Palantir for Big Data Health Initiative (Bloomberg)
  • EU approves Gilead's hepatitis B therapy Vemlidy (PharmaTimes)
  • As Talks Loom, 'Hard Brexit' Option Raises Fear of Tariffs (NYTimes)
  • ICH Offers Reflection Paper on Good Clinical Practice Revisions (Focus)
  • News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents (Patent Docs)
  • Ascletis Eyes Launch Of China's First Oral HCV Drug, Possible IPO (SCRIP-$)
  • Pharma Executives To Watch In China In 2017 (SCRIP-$)
  • Millions of children to receive measles vaccine in north-eastern Nigeria (WHO)
  • Celgene partners with UK's Oxford Sciences Innovation (PharmaLetter-$)
  • NHS misses all major performance targets for November (PharmaTimes)

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US: Pharmaceuticals & Biotechnology

  • Drug price control measures fail in Senate (BioCentury)
  • Advancing the Pharmaceutical Supply Chain (Pharmafile)
  • National Academies: More and Better Cannabis Research Needed (Medpage) (Forbes)
  • Analyst says Celyad takes lead in CAR-T for solid tumors as THINK trial gets underway (Fierce)
  • Merck, Lilly to test new combo for soft tissue sarcoma (PharmaTimes)
  • Nivalis axes CEO, 80% of staff after failed cystic fibrosis trial (Fierce)
  • Good News/Not So Good News II? Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (Lachman Consultants)

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

  • Shionogi's cefiderocol passes Phase II cUTI test (BioCentury)
  • Sunovion Announces Top-line Results from Studies Evaluating Dasotraline in Adults with Binge Eating Disorder and Attention Deficit Hyperactivity Disorder (Press)
  • New Data Show SPINRAZA™ (nusinersen) Significantly Reduces Risk of Death or Permanent Ventilation in Infantile-Onset Spinal Muscular Atrophy (Press)

US: Medical Devices

  • Dexcom surges on Medicare nod for continuous glucose monitors (MassDevice)
  • Johnson & Johnson recalls DePuy Synthes knee component (MassDevice)
  • Can wearable sensors tell when you're sick? (Reuters)
  • Bracco Diagnostics wins another FDA nod for Lumason microspheres (MassDevice)
  • The Serious And Immense Impact Of A Medical Device Hack (Law360-$)
  • Philips Announces New Augmented Reality Spine Surgery Navigation Tech (Medgadget)

US: Assorted & Government

  • U.S. judge blocks rule on financial assistance for dialysis patients (Reuters)
  • Court Finds Fraudulent Joinder by Relying on a Sales Rep's Affidavit and Common Sense (Drug & Device Law)
  • Price Unfit to be HHS Secretary, Doc Groups Say (Medpage)
  • Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised Draft Guidance for Industry (FDA)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee – 17 March 2017
  • eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course – March, April, May
  • European Medicines Agency and Medicines for Europe annual bilateral meeting – 24 January 2017

Europe

  • Biosimilars applications under review by EMA – December 2016 (GaBI)
  • Doctors warn prime minister of threat to patient care (PharmaTimes)

Asia

  • Macau native contracts bird flu after visit to China: Xinhua (Reuters)

India

  • Donald Trump's words spook Indian pharma stocks (Economic Times)
  • Maha FDA to prosecute two Nashik-based firms for purchasing drugs with fake documents (PharmaBiz)
  • Lupin launches generic morphine sulfate tablets in US (Economic Times)

Australia

  • Consultations on adoption of European Union guidelines in Australia: Outcome of previous consultation (TGA)
  • Updates to the Prescribing Medicines in Pregnancy database (TGA)
  • Literature review on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens (TGA)
  • Declaration of conformity templates (IVDs) (TGA)

Zika

  • The race to develop a vaccine: Scientists inch closer to preventing Zika (Washington Post)
  • Scientists don't have a decade to find a Zika vaccine. They need volunteers now. (Washington Post)

Other International

  • As drug supplies run short, Egyptians turn to herbal remedies (Reuters)

General Health & Other Interesting Articles

  • Rural Americans at higher risk of death from five leading causes (CDC)
  • Tom Knight's Ginkgo Bioworks Seeks To Reinvent Moore's Law Through Biochemistry (Forbes)

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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