Recon: FDA weighs another round of COVID boosters for high-risk individuals; Thermo Fisher, Celltrion in running to buy Baxter’s biopharma business
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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