Recon: Opioid makers score a win in California trial; Pfizer sees 2021, 2022 COVID vaccine sales to hit $65B

| 02 November 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Opioid Makers Win Major Victory in California Trial (NYTimes) (Reuters) (STAT)
  • Pfizer expects 2021, 2022 COVID-19 vaccine sales to total at least $65 bln (Reuters) (FT)
  • U.S. CDC advisers to vote on COVID-19 vaccine in young children (Reuters)
  • FDA extends review of J&J, Legend's cell therapy for multiple myeloma (BioPharmaDive)
  • Progressive Democrats scramble to secure curbs on drug prices (FT) (STAT)
  • Manchin Raises Doubts on Safety Net Bill, Complicating Path to Quick Vote (NYTimes 1, 2)
  • White House says 15 mln COVID-19 shots will roll out to children by next week (Reuters)
  • U.S. buys more doses of Lilly's COVID-19 treatment for $1.29 bln (Reuters)
  • Moderna, making billions from its vaccine, bets on a genome-editing startup (STAT) (Endpoints)
  • Amylyx asks FDA to approve ALS drug, while also preparing late-stage study (BioPharmaDive)
In Focus: International
  • EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly (EMA)
  • AstraZeneca increases COVID-19 vaccine supply to Thailand after row (Reuters)
  • Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says (Reuters)
  • Novartis enlists transatlantic startup to discover new protein degraders in $1.3B+ deal (Endpoints)
Coronavirus Pandemic
  • ‘Not Quite on Board’: Parents Proving a Tough Sell on Covid Vax for Teens (KHN)
  • Bahrain approves Pfizer COVID vaccine for children aged 5-11 (Reuters)
Pharma & Biotech
  • Could Robert Califf’s ties to tech complicate his FDA nomination? (STAT)
  • Pfizer reveals delays across the board for its clinical gene therapy programs (Endpoints)
  • As anti-inflammatory space heats up, Pfizer spins JAK, TYK2 drugs into new startup (Endpoints)
  • Clene's mid-stage ALS drug hits a brick wall, but can an 'efficacy signal' save the day? (Endpoints)
  • US FDA Chief Scientist Hinton’s Departure Leaves Vacancy Atop Makena Decision Tree (Pink Sheet)
  • Fresh off Kite and BeiGene deals, Shoreline ups the ante with a hefty crossover. But the biotech insists it's in no rush (Endpoints)
  • AbbVie, Janssen, Novartis, Pfizer and UCB to jointly advance 'digital' endpoint for atopic dermatitis (Endpoints)
  • Perceptive steers LianBio's globally connected China strategy to $325M IPO (Endpoints)
  • Safety of Endologix endovascular graft device center of FDA panel review (MedtechDive)
  • GV-backed Cambridge Epigenetix lines up $88M to roll out genetic sequencing technology (Fierce)
  • Can Regional Trade Pact Force Change On Chinese Local Medtech Procurement? (MedtechInsight)
Government, Regulatory & Legal
  • Federal Court Orders Tampa Pharmacy to Close in Case Alleging Unlawful Opioid Distribution (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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