rf-fullcolor.png

 

October 28, 2021
by Michael Mezher

Recon: US buys 50M doses of Pfizer vaccine for kids; Biden abandons drug pricing plans

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer gets U.S. contract for 50 mln COVID-19 vaccine doses for kids (Reuters)
  • Biden abandons his push to lower drug prices (STAT)
  • Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show (STAT)
  • Merck ready to deploy tens of millions of its Covid antiviral pills if regulators approve, CEO says (CNBC)
  • 1.5 million Americans got a Moderna or J&J Covid booster shot in the first 5 days, White House says (CNBC)
  • Public-private partnership launched to accelerate gene therapies for rare diseases (STAT) (FDA)
  • Feds probe Novartis over Entresto marketing and compensation to doctors (STAT)
  • Some immunocompromised people can receive a 4th Covid shot, CDC says (NBC)
  • Labcorp raises annual profit forecast as demand for clinical trials rebound (Reuters)
  • U.S. CDC panel to discuss COVID-19 shots for younger kids on Nov. 2 (Reuters)
  • Up to 50M doses of J&J vaccine sitting idle in factory: report (The Hill)
In Focus: International
  • EU set to produce over 3.5 billion COVID vaccine doses in 2022 - chief executive (Reuters)
  • A cheap antidepressant lowers the risk of Covid hospitalization, a large study finds. (NYTimes)
  • WHO, partners seek $23.4 bln for new COVID-19 war chest (Reuters)
  • India's Optimus Pharma seeks approval to produce generic Merck COVID-19 pill (Reuters)
Coronavirus Pandemic
  • Should I Mix or Match My Booster Shot? (NYTimes)
Pharma & Biotech
  • HHS unveils drug overdose prevention plan to boost accessibility to care (The Hill)
  • Alnylam’s longtime CEO to depart, new leader named (STAT)
  • Seagen’s breast cancer drug Tukysa turned down by NICE (Pharmaphorum)
  • Looking to win back investor confidence, BioMarin preps for its ‘largest launch’ (Endpoints)
  • BMS reports strong growth as its Q3 results beat predictions (PMLive)
  • Rafael Pharma drug fails to prolong survival of patients with pancreatic cancer in large study (STAT)
  • EMA nod for excessive daytime sleepiness med Ozawade (PharmaTimes)
  • FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing (Endpoints)
  • A pair of partners at Frazier is following early-stage biotechs to the public market with an $830M fund. And they're already doing deals (Endpoints)
  • Koch leads mammoth $215M infusion into AI startup boasting 'largest database' of immune cells (Endpoints)
  • Checkmate CEO hits the exit as Art Krieg's crew struggles to warm investors to TLR9 strategy (Endpoints)
Medtech
  • Patients Must Be Warned of Breast Implant Risks, F.D.A. Says (NYTimes) (FDA)
  • Northwestern spinout Sibel Health scores FDA clearance for patient monitoring system (MobiHealthNews)
  • Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap (MedtechInsight)
  • AdvaMed Launches Ethics Code To Meet ‘Business & Market Realities’ In India (MedtechInsight)
Government, Regulatory & Legal
  • Academics Back Illumina's Grail Buy Against FTC Challenge (Law360)
  • Regeneron Gets PTAB To Review Syringe Patent On 2nd Go (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.