Regulatory Focus™ > News Articles > 2021 > 9 > Recon: FDA authorizes boosters for at-risk and older Americans; Novavax applies for WHO emergency li

Recon: FDA authorizes boosters for at-risk and older Americans; Novavax applies for WHO emergency listing

Posted 23 September 2021 | By Michael Mezher 

Recon: FDA authorizes boosters for at-risk and older Americans; Novavax applies for WHO emergency listing

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Authorizes Pfizer Booster Shots for Older and At-Risk Americans (NYTimes) (Reuters) (STAT) (FDA)
  • Pfizer CEO rallies staff to fight Democrats’ drug price negotiation (Politico)
  • Moderna chief executive sees pandemic over in a year (Reuters)
  • Novavax applies to WHO for emergency listing of COVID-19 vaccine (Reuters)
  • Biosimilar Drugs Are Cheaper Than Biologics. Are They Similar Enough to Switch? (KHN)
  • The U.S. is discarding millions of Covid vaccines. One cause: Multi-dose vials. (NBC)
  • FDA approves Incyte's Jakafi for cGVHD (FDA)
  • New research cautions about possible risks of acetaminophen use during pregnancy (STAT)
  • Takeda Owes AbbVie for Lupron Breach, as Trial on Damages Looms (Bloomberg) (Law360)
  • Mitch McConnell, top Republicans question Biden on getting ahead of FDA on Covid-19 boosters (Endpoints)
In Focus: International
  • EU regulator to decide on Pfizer booster dose at the start of October (Reuters)
  • Global Leaders Commit Further Support For Global Equitable Access To Covid-19 Vaccines And Covax (WHO) (Reuters)
  • At Covid Summit, Biden Sets Ambitious Goals for Vaccinating the World (NYTimes)
  • Some experts say that Biden’s new plan for donating vaccines falls short. (NYTimes)
  • AstraZeneca invests in Imperial's self-amplifying RNA technology with eye on future drugs (Reuters) (FT)
  • Valneva expands trials on COVID-19 vaccine candidate (Reuters)
  • India likely to allow export of Sputnik Light COVID shot this month – sources (Reuters)
Coronavirus Pandemic
  • Majority of patients with rare coronavirus-related inflammatory disease admitted to ICU (The Hill)
Pharma & Biotech                                                                                                     
  • Do not enter: Biogen reps banned from D.C.-area neurology clinics over controversial Alzheimer's drug Aduhelm (Fierce)
  • Eli Lilly gets behind the latest approach to solving gene therapy's delivery problem (Endpoints)
  • Amgen’s Biosimilar Trends Report shows benefit of competition from biosimilars (PMLive)
  • Allarity Therapeutics partners with Lonza to manufacture Dovitinib (Pharmafile)
  • Faced with generic rivals, Amarin cuts 400-plus sales reps as part of revamped Vascepa strategy (Fierce)
  • Santhera Raises CHF45m Ahead Of Duchenne Drug Filing (Scrip)
  • Oxford Biomedica sees new investment for manufacturing; Twist gets a partner to help build out discovery libraries (Endpoints)
  • Looking to make donor cells obsolete, an ex-Harvard researcher gets off-the-shelf stem cell biotech off the ground (Endpoints)
  • Foresite recruits Principia vet Martin Babler — and his old team — to occupy the C-suite of a startup (Endpoints)
  • Cigna names new CEO of pharmacy benefit management business (Reuters)
  • Roche's Foundation Medicine is getting a new 16-story home in Boston's Seaport District (Endpoints)
Medtech
  • FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event (MedtechDive)
  • Lab platform Opentrons closes $200M series C to build out robotics, diagnostics, cell engineering services (Fierce)
  • Welldoc's Bluestar lands FDA clearance for expanded insulin dosing support (mobihealthnews)
  • FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’ (MedtechInsight)
  • Know Labs unveils pocket-sized glucose monitor that swaps fingersticks for radiofrequency sensors (Fierce)
Government, Regulatory & Legal                                                                                                                                       
  • Elizabeth Holmes’ private texts reveal she described herself as the ‘best business person of the year’ (CNBC)
  • Federal officials move closer to penalizing drug makers for failing to offer discounts to safety-net hospitals (STAT)
  • Pharma Giants' $454M Glumetza Antitrust Deal Gets Initial OK (Law360)
  • Senate Panel Grills Biden's Pick For HHS Watchdog (Law360)
  • Pain Doctor Convicted of Over $100 Million Health Care Fraud Scheme (DOJ)
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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