Recon: GSK, Vir seek EUA for COVID antibody; FDA adcomm votes 19-to-1 against Pfizer’s tanezumab

| 26 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden sets goal of 200 million US COVID-19 shots in his first 100 days (Reuters) (Politico)
  • J&J on track to meet vaccine delivery goal, White House says (Politico)
  • For Biden, a New Virus Dilemma: How to Handle a Looming Glut of Vaccine (NYTimes)
  • ‘Alex Azar Anonymous’: Trump health officials start a club to counter former HHS chief (Politico)
  • Autopsy of a pandemic: 6 doctors at the center of the US Covid-19 response (CNN)
  • GSK and Vir seek emergency use of COVID-19 therapy in United States (Reuters)
  • New study to test Moderna vaccine in transmission prevention among college students (Reuters)
  • FDA expert panel lines up 19-to-1 against Pfizer’s osteoarthritis drug tanezumab (Endpoints) (Press)
  • The Great Undoing: Which of Trump’s Policies Will Biden Reverse? (KHN 1, 2)
In Focus: International
  • EU pledges to keep AstraZeneca doses in the bloc for now (Reuters)
  • EU leaders agree to step up COVID-19 vaccine production in Europe (Reuters)
  • No more vaccine exports until you fulfill your contracts, EU tells AstraZeneca (Reuters)
  • Novavax delays EU vaccine supply deal amid production problems (Reuters)
  • Moderna plans factory in eastern Germany, FAZ reports (Reuters)
  • Moderna delays shipment of about 600,000 COVID-19 vaccine doses to Canada (Reuters)
  • Thermo Fisher to work with Pfizer-BioNtech on vaccine production in Italy (Reuters)
  • EU clears vaccine sites to boost inoculation drive (Reuters) (EMA)
  • EMA advises limited use of Celltrion COVID-19 drug, says benefits still unclear (Reuters) (EMA)
  • Japan's Takeda starts regulatory submissions for dengue vaccine in Europe (Reuters)
  • Commission welcomes entry into force of EU4Health programme (EC 1, 2)
Coronavirus Pandemic
  • Volunteers break rank to raise doubts in trial of Russia's second COVID-19 vaccine (Reuters)
  • Air crews, seafarers should be prioritised for COVID-19 vaccines - WHO, ICAO, IMO (Reuters)
  • Colombia grants emergency use for J&J coronavirus vaccine (Reuters)
  • EU says on track for 70% of adults vaccinated in second quarter (Reuters)
  • UK will have vaccine supply to meet targets, minister says (Reuters)
  • UK study finds strong immune responses from one dose of Pfizer COVID-19 shot (Reuters)
  • Norway keeps AstraZeneca vaccine on hold for another three weeks (Reuters)
  • Iran plans to start making Russia's Sputnik V vaccine in April -RIA (Reuters)
Pharma & Biotech
  • AstraZeneca’s data missteps shows that drug regulation actually works (Quartz)
  • EU Council Agrees Compromise Position On Joint Clinical Assessments (Pink Sheet) (Council)
  • The pandemic dramatically reduced flu cases. That could backfire. (Politico)
  • FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients (FDA)
  • Lawmakers are once again eyeing drug prices—and this time, the threat to pharma is real: analysts (Fierce)
  • Gilead poaches Amgen exec Flavius Martin to run its R&D as 30-year veteran Bill Lee retires (Fierce)
  • EMA begins accelerated review of Gilead’s Trodelvy for triple-negative breast cancer (PMLive)
  • Inspectors grounded - a year of innovation (MHRA)
  • FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients (FDA)
  • FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease (FDA)
  • BrainScope debuts concussion-rating algorithm on its handheld device (Fierce)
  • Boston Scientific links just approved liver cancer device to improved survival (MedtechDive)
  • Stryker, Zimmer make data and analytics a top priority as robotic procedures ramp up (MedtechDive)
Government, Regulatory & Legal
  • Fed. Circ. Denies Another Stanford Genetics Patent Over Alice (Law360)
  • PTAB To Review University Of Calif. Ocular Blade Patent (Law360)
  • Mitsubishi Beats Bid To Invalidate Diabetes Drug Patents (Law360)
  • Cherokees Can't Widen Opioid Discovery, Companies Say (Law360)
  • Hologic Tells Justices Assignor Estoppel Is Settled Law (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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