Recon: Pfizer Says COVID Vaccine 90.7% Effective in Children 5-11 Years Old; Oncopeptides pulls Pepaxto from the back

Posted on October 22, 2021 | Through Michel mezher

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

Focus: United States

  • US Walgreens stores start administering Moderna, the J&J COVID-19 booster (Reuters)
  • Americans can mix and match COVID-19 boosters but original vaccine recommended -Fauci (Reuters)
  • CDC recommends Covid Booster injections to millions of Americans (NYTimes) (STAT)
  • Pfizer / BioNTech COVID-19 vaccine shows 90.7% efficacy in trial in children (Reuters)
  • Oncopeptide stock craters as it withdraws cancer drug Pepaxto from the market (endpoints)
  • The four senators who could make or break Democrats’ ambitions for drug prices (STAT)
  • Bat Research Group Failed To Submit Virus Studies Quickly, NIH Says (NYTimes)
  • US Warns of China’s Efforts to Collect DNA Data (NYTimes)

Focus: international

  • Norway chooses not to give second dose of vaccine to 12-15 year olds yet (Reuters)
  • Illumina to launch Grail’s cancer test in Africa and Asia – but not sure when (STAT)
  • Novartis has negotiated access to Zolgensma for half of Europe’s SMA population, the executive said. How did it come to this? (Fierce)

Coronavirus pandemic

  • Delta ‘Plus’ Covid variant could be more transmissible (BBC)
  • Covid-19 rally: White House calls for support for waiver of intellectual property at the WTO; Rare nervous disorder listed as a side effect of AstraZeneca in UK (endpoints)

Pharma & Biotech

  • Sanofi and Regeneron Sign New PhIII Victory for Dupixent, Relieving Severe Itching and Eliminating Lesions (Endpoints)
  • After August meltdown, Zymergen hints at bailouts – job cuts and loan renegotiations (Endpoints)
  • New Treg player emerges with $ 46 million and Takeda backing (Endpoints)
  • Xilio Therapeutics goes public as biopharmaceutical IPOs advance in Q4 (endpoints)
  • Former MIT scientist David Sabatini hits back at Whitehead Institute accuser over ‘false’ harassment claims (Endpoints)
  • Agenus calls FDA for playing favorites with Merck, withdraws BLA from cervical cancer at agency request (Endpoints) (BioPharmaDive)
  • Dupixent meets all parameters of the prurigo nodularis trial (PharmaTimes)
  • Servier colorectal cancer phase III trial fails primary endpoint (Fierce)
  • Sweden tackles regulatory barriers to decentralized testing (pink sheet)
  • Metacrine shares halved as NASH program canceled over mixed bag data and early safety issue (Fierce)

Medtech

  • Hearing aids: Holders have a solid foundation for withstanding disruption (FT)
  • Ocular Therapeutix Hammered By PhII Failure In Dry Eye Disease – Shares Reservoir (Endpoints)
  • FDA panel recommends against approving Integra mesh for breast reconstruction (MedtechInsight)
  • Luminopia Notes FDA De Novo For VR Treatment For Lazy Eyes (Mobihealthnews)

Government, Regulation and Legal

  • Lilly broke contract by not paying royalties on top-selling diabetes drugs, court says (Fierce)
  • Apotex backs Teva’s En Banc offer in fight against skinny labels (Law360)
  • Hill-Rom, Baxter Receive FTC Warning Letters Over $ 12.4 Billion Deal (Law360)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you key regulatory, biopharmaceutical and medical news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

© 2021 Society of Regulatory Affairs Professionals.


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