Recon: FDA panel to weigh in on Merck’s COVID antiviral pill; Aspen signs deal for J&J COVID vaccine

| 30 November 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters (FDA)
  • U.S. FDA panel to weigh Merck's COVID-19 antiviral drug (Reuters) (NYTimes) (NPR)
  • Biden says he will direct FDA, CDC to use ‘fastest process available’ to clear Covid vaccines targeting omicron (CNBC)
  • Merck says its COVID-19 drug should be effective against any variant (Reuters)
  • Pfizer to seek authorization for Covid booster for teens 16 and 17 (NBC)
  • All adults should get a Covid booster shot, CDC says (Politico)
  • Pfizer research head envisions a sprint to develop Omicron vaccine, if it’s needed (STAT)
  • Covid-19 Antibody Drugs Are Challenged by Omicron, Preliminary Testing Indicates (WSJ)
  • Shkreli, former company ask judge to find no wrongdoing in Daraprim lawsuit (Reuters)
  • FDA cancels ODAC meeting this week to review two more dangling accelerated approvals — but won't explain why (Endpoints) (Pink Sheet)
In Focus: International
  • Moderna boss predicts current vaccines may be less effective against Omicron (The Guardian)
  • S.Africa's Aspen signs deal paving way for J&J COVID vaccine license (Reuters)
  • GSK names Pfizer scientist Dormitzer as vaccines R&D head (Reuters) (Endpoints)
  • EU could approve shot against new coronavirus variant in 3-4 months (Reuters)
Coronavirus Pandemic
  • Counterfeit Covid Masks Are Still Sold Everywhere, Despite Misleading Claims (NYTimes)
  • Oxford University says no evidence yet that vaccines won't protect against severe disease from Omicron (Reuters)
  • The inside story of the Pfizer vaccine: ‘a once-in-an-epoch windfall (FT)        
  • Doctors hope Omicron causes milder cases of Covid — but it’s still too early to say (Reuters)
  • Abbott, BD join chorus of COVID-19 test makers claiming diagnostics not impacted by omicron variant (MedtechDive)
  • U.S. vaccine diplomacy czar Gayle Smith leaves role (Reuters)
  • China’s top mRNA contender is ready to go. And SoftBank just led a cash infusion pushing it over the $1B line (Endpoints)
  • Slovenia set to ban Janssen vaccine after woman's death (Reuters)
Pharma & Biotech
  • Immunogen study achieves primary goal of shrinking tumors in patients with ovarian cancer (STAT)
  • As lead drug runs into a wall, Deciphera slims down its pipeline, puts 140 jobs on the chopping block (Endpoints)
  • US FDA Cast As Culpable Player In Opioid Epidemic In Hulu’s Dopesick Series (Pink Sheet)
  • FDA raises concerns over TG Therapeutics' survival data, plans to convene ODAC (Endpoints)
  • Blueprint, taking aim at larger drugmakers, becomes a biotech buyer (BioPharmaDive)
  • ImmunoGen touts a PhIII comeback in ovarian cancer, eyeing a 2022 accelerated approval (Endpoints)
  • After Big Pharma sparked interest in the US, Ablaze looks to bring radiopharmaceuticals overseas (Endpoints)
  • After refuting a supposed data leak as 'falsified', Olema reveals first clinical data for lead program — shares crash (Endpoints)
  • Mei, with Bayer and Gilead in its sights, posts pivotal data on blood cancer prospect (Fierce)
  • Precautionary recall of specific batches of blood pressure drug irbesartan (MHRA)
  • FDA updates eSTAR ahead of expanding filing template for De Novo submissions (MedtechDive)
  • First Belgian Notified Body Appointment Brings EU MDR Total To 25 (MedtechInsight)
  • IVDR milestone as EU expert panel delivers first opinion on a diagnostic submission (MedtechDive)
  • Commission Publishes Implementing Regulation That Acts As Basic Starter Manual For Eudamed (MedtechInsight)
  • Owlet pulls baby-monitoring Smart Sock from market after FDA warning (Fierce)
  • Hyperfine’s portable MRI nets FDA clearance for deep learning-powered imaging (Fierce)
  • BD ramps up tech development with new science chief, scientific advisory board (Fierce)
Government, Regulatory & Legal
  • Catalent Can't Duck IP Suit Over Epilepsy Drug Vimpat (Law360)
  • Mallinckrodt Gets Ch. 11 Stay Of Acthar Suits Extended (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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