Recon: FDA weighs another round of COVID boosters for high-risk individuals; Thermo Fisher, Celltrion in running to buy Baxter’s biopharma business

• FDA May Authorize Additional Covid-19 Booster Shots (WSJ) (Reuters)
• US FDA to take steps to help gene therapies get accelerated approval (Reuters) (STAT)
• ALS drug rekindles accelerated approval debate (Politico)
• Thermo Fisher, Celltrion vie for Baxter's biopharma unit (Reuters)
• Moderna expects to price its COVID vaccine at about $130 in the US (Reuters)
• Biden signs bill requiring declassification of COVID origins information (Reuters)
• Candida auris fungus spreading in U.S. hospitals – CDC (Reuters)

• Oxford Nanopore open to possibility of overseas listing (FT)
• Chinese COVID data from animal market gives clues on origins, report says (Reuters)
• BioNTech to develop, produce cancer drugs and vaccines in Jerusalem -Israel Fin Min (Reuters)
• MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years (MHRA)
• One final push: EU pharma industry group demands competition check on incoming legislative overhaul (Endpoints)
• The ICH Q9(R1) Introductory Training Presentation is now available on the ICH website (ICH)

• Biotech AI startup Unlearn adds $15 mln and OpenAI CTO to board (Reuters)
• Altimmune's obesity drug throws up safety concerns, shares plunge (Reuters) (STAT)
• Steroid drug reduces death rate in severe pneumonia, study shows (STAT)
• FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development (Pink Sheet)
• US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends (Pink Sheet)
• As approvals roll in, Takeda details pricing strategy for dengue vaccine launch (Fierce)
• After raising $140M, SPAC will take biotech public with a fraction of planned funds (Endpoints)
• Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma (Fierce)
• AAD: Awaiting FDA decision in psoriasis, UCB touts 48-week data for bimekizumab in hidradenitis suppurativa (Fierce)
• Incyte touts mid-stage data for new JAK inhibitor but stops short of selecting PhIII dose (Endpoints)
• Kite's head of research leaves for Flagship startup Sonata (Endpoints)
• Sobi's PhIII gout win sets up a potential rivalry with future Amgen asset (Endpoints)
• Contraceptive maker Evofem lets commercial chief go, cuts CEO pay 40% to save cash (Endpoints)

• A new Medicare ruling could give virtual reality companies an easier path to payment (STAT)
• Another Class I Recall For Datascope’s Aortic Balloon Pumps (MedtechInsight)
• J&J’s Ashley McEvoy named chair of AdvaMed (MedtechDive)
• Boston Scientific, Medtronic expected to quickly capture new atrial fibrillation market: analysts (MedtechDive)
• Spine robot maker Accelus gains another FDA clearance (MedtechDive)
• Viz.ai snags FDA nod for AI to spot abdominal aortic aneurysms in chest scans (Fierce)

• A sign of what's coming? Presidential hopeful DeSantis targets PBMs and pharma transparency (Endpoints)
• Merck, Viatris agree to settle patent feud surrounding diabetes drugs (Endpoints)
• DOJ Defends Ask For Docs From Drug Price-Fixing MDL (Law360)
• FDA Urges Court To Keep Abortion Drug Regulations Intact (Law360)