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December 6, 2021
by Michael Mezher

Recon: FDA adds warnings on Abbvie, Lilly and Pfizer JAK drugs; EMA recommends Roche arthritis drug for severe COVID

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biden’s free at-home test promise could come with added costs (Politico)
  • Pfizer could have vaccine data for kids under age 5 by year-end, CEO says (NBC)
  • Merck takes aim at Pfizer’s Covid pill as concerns linger over its own drug (FT)
  • Documents reveal the secrecy of America's drug pricing matrix (Axios)
  • Johnson & Johnson Prepares to Untangle Finances Ahead of Planned Split (WSJ)
  • FDA adds strict safety warnings on arthritis drugs from Pfizer, AbbVie and Lilly (Reuters)
In Focus: International
  • UK’s BenevolentAI agrees Europe’s largest Spac deal (FT) (Fierce)
  • WHO advises against use of convalescent plasma for covid-9 (WHO)
  • EU regulator backs Roche's arthritis drug for treating severe COVID-19 (Reuters)
  • Pfizer and Merck Covid-19 Pills Are Coming Soon in the U.S., but Other Countries Will Have to Wait (WSJ)
  • AstraZeneca blocks take-private buyout of Sobi (PMLive)
  • AstraZeneca Studies Listing of New Vaccines Division (Bloomberg) (Fierce)
  • Novartis working on pan-coronavirus oral treatment, CEO says (Reuters)
  • COVID shots are finally arriving, but Africa can't get them all into arms (Reuters)
  • South Africa's Biovac to start making Pfizer-BioNTech COVID-19 vaccine in early 2022 – exec (Reuters)
Coronavirus Pandemic
  • Next pandemic could be more lethal than COVID, vaccine creator says (Reuters)
  • Merck ties up with Thermo Fisher to make its COVID-19 pill in Canada (Reuters)
  • Fauci says booster shots likely give cross protection against ‘wide range’ of Covid variants (CNBC)
  • Is It Time to Change the Definition of ‘Fully Vaccinated’? (KHN)
  • A J.&J. booster works well for people who had Pfizer-BioNTech doses originally, a study finds. (NYTimes)
  • ‘Wall of secrecy’ in Pfizer contracts as company accused of profiteering (The Guardian)
  • Vials of Remdesivir recalled due to glass contamination (The Hill)
  • Russia has sent documents to India for Sputnik M registration, says RDIF (Reuters)
  • Omicron spreads in India, full vaccination in focus (Reuters)
  • Roche launches 3 omicron variant research tests days after TIB Molbiol buy (Fierce)
  • Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant (MedtechDive)
Pharma & Biotech
  • Novartis petitions FDA to block 18 generic competitors for its megablockbuster heart drug until 2024 (Endpoints)
  • Pfizer, Amgen and Janssen seek further clarity on FDA's new benefit-risk guidance (Endpoints)
  • FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma (FDA)
  • The 2022 wave coming? Top analyst says Big Pharma will have more than $1T available to satisfy its growing appetite for biotech M&A (Endpoints)
  • Stoke Therapeutics drug, targeting genetic cause of childhood epilepsy, reduces seizure activity (STAT)
  • Biohaven's migraine therapy shows rapid pain relief in late-stage study (Reuters) (BioPharmaDive)
  • FDA slams Reata's kidney drug as ineffective ahead of adcomm meeting (Endpoints)
  • Recordati acquires EUSA Pharma and its 4 rare disease drugs, but analysts question strategy behind the deal (Endpoints)
  • Bolt Bio goes bust as investors boo single response in early test against HER2-expressing tumors (Endpoints)
  • Even as boom wanes, a new $200M SPAC is still hoping for another big score (Endpoints)
Medtech
  • BD finalizes name and leadership for its billion-dollar diabetes spinoff (Fierce)
  • RefleXion snags FDA breakthrough status for cancer-guided radiotherapy to treat lung tumors (Fierce)
Government, Regulatory & Legal
  • Congress passes on delay to Medicare rate cuts for lab tests, for now (MedtechDive)
  • Zoll Medical Escapes Liability For Alleged Defibrillator Defect (Law360)
  • Mallinckrodt Escapes $320M Acthar Antitrust Claim In Ch. 11 (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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