Regulatory Focus™ > News Articles > 2021 > 11 > Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authoriza

Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'

Posted 17 November 2021 | By Michael Mezher 

Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Plans to Authorize Pfizer Boosters for All Adults This Week (NYTimes)
  • Watchdog group calls on FDA to disqualify Hennepin Healthcare doctors, review board from clinical research (StarTribune)
  • U.S. plans to invest billions in manufacturing COVID-19 vaccine (Reuters) (Politico)
  • Pfizer CFO D'Amelio to retire after 15 years at company (Reuters)
  • U.S. secures GSK-Vir COVID-19 antibody therapy doses worth $1 bln (Reuters)
  • MCIT breakthrough device payment pathway included in Cures 2.0 bill (MedtechDive)
  • Cardinal Health to Test Drone Delivery to Pharmacies (WSJ)
  • Legal battle over Biden Covid vaccine mandate heads to federal appeals court with GOP-appointed majority (CNBC)
  • Vials labeled 'smallpox' found at vaccine research facility in Pennsylvania, CDC says (CNN) (Endpoints)
In Focus: International
  • EU decision on Novavax COVID-19 shot could come 'within weeks' (Reuters)
  • EU watchdog to announce view on vaccine for children next week- Austria (Reuters)
  • Biogen's Alzheimer's drug gets negative European panel vote (Reuters) (FT) (STAT) (Press)
  • Roche walks away from Atea partnership to develop COVID-19 pill (Reuters)
  • Ahead of expected EU objections, Illumina defends Grail acquisition (Endpoints)
Coronavirus Pandemic
  • Factbox: Front runners in development of antibody drugs against COVID-19 (Reuters)
  • Russia's Sputnik V vaccine shows 96.3% COVID-19 efficacy in Belarus – RDIF (Reuters)
  • Trump gave an agency $100 million to fight Covid. Here’s what happened. (NBC)
Pharma & Biotech
  • U.S. drug overdose deaths top 100,000 annually – CDC (Reuters)
  • Pfizer on the hunt for a new CFO as Frank D'Amelio retires after nearly 15 years (Endpoints)
  • OCE 2.0? US FDA Leadership Change May Present Opportunity To Grant Full Review Authority (Pink Sheet)
  • ‘Where’s my prescription?’: California wants to revoke an OptumRx pharmacy license for prescribing lapses (STAT)
  • First Alzheimer’s vaccine human trial set to begin at Boston hospital (NBC)
  • Epizyme rolls out rare blood cancer effort with patients' stories and friendly digital coach (Endpoints)
  • Cassava's problems just got much worse as SEC launches probe into data manipulation claims — report (Endpoints)
  • Atlas, Newpath throw $125M behind a new approach to gene editing from the field’s biggest names (Endpoints)
Medtech
  • FDA grants first approval for a VR system to treat chronic lower back pain (Fierce) (FDA)
  • Globus in takeover talks with NuVasive to boost spine portfolio: reports (MedtechDive)
  • Accelus sizes up $482M SPAC deal to take its minimally invasive spinal surgery tech public (Fierce)
  • Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth (MedtechDive)
  • Don’t Call Them Inspections: EUA Holders Shouldn’t Be Surprised If FDA Shows Up To Investigate (MedtechInsight)
Government, Regulatory & Legal
  • Fed. Circ. Clears Alkem In Horizon Painkiller IP Row (Law360)
  • Pfizer Must Face Trimmed Robitussin Labeling Suit (Law360)
  • Former Generic Industry Exec Who Went Undercover For DOJ No Longer Debarred (Pink Sheet)
  • Merck, Glenmark Want Jury To Decide Zetia Antitrust Market (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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