Recon: HHS ending use of Anthropic’s Claude AI; FDA gives breakthrough designation to AI chatbot for patients undergoing surgery
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- HHS starts phasing out Anthropic’s Claude (STAT)
- CMS' Chris Klomp on what it will take for AI to succeed in healthcare (Endpoints)
- ICER calls on CMS to lower price of Takeda blockbuster Entyvio to Stelara's level (Endpoints)
- Drugmakers Pressure Trump to Withdraw Foreign Pricing Frameworks (Bloomberg Law)
- Moderna agrees to pay up to $2.25 billion to settle COVID vaccine patent dispute (Reuters)
- Eli Lilly on track to launch oral obesity drug in second quarter, pending US approval (Reuters)
- Exclusive: US postpones third consecutive meeting of preventive health panel (Reuters)
- Amid unfolding Middle East war, pharma giants keep close eye on employee safety, supply chains (Fierce Pharma)
- MAHA goes global: Inside the rise of the Make Europe Healthy Again movement (STAT)
- Aspen Pharmacare expects Canada entry with Ozempic generic by third quarter (Reuters)
- African drugmaker Aspen reports 21% earnings decline due to one-off costs (Reuters)
- Boston Scientific gets Farapulse label expansion in Europe (MedTech Dive)
- FDA is ‘not convinced’ UniQure’s Huntington’s therapy has benefit, senior official says (STAT)
- FDA grants ‘breakthrough’ status to generative AI chatbot for surgical patients (STAT)
- 6 key dilemmas as human embryo models get ever closer to the real thing (STAT)
- Geopolitics Now Play Key Role in Boardrooms, Fresenius CEO Says (Bloomberg)
- Theravance ends R&D, lays off half of workforce after repeated Phase 3 fails (Endpoints)
- Boehringer Ingelheim tried to use a tempting, tough cancer target for liver disease. It didn’t work (Endpoints)
- Hims’ pharmacy partner will reintroduce GLP-1 pill pulled from market (Endpoints)
- Esperion to buy Corstasis and its nasal spray for edema for $75M upfront (Endpoints)
- Roche targets double-digit market share in weight loss, aims to catch up with Novo Nordisk, Handelsblatt reports (Reuters)
- Diagnostics startup Droplet Biosciences partners with Nvidia to speed cancer test results (Reuters)
- RadNet to acquire radiology AI company Gleamer (MedTech Dive)
- Fresenius Kabi recalls Ivenix infusion pumps over software problem (MedTech Dive)
- Stakeholders Ask CMS For Additional TAVR Indications (MedTech Insight)
- Mondelēz CEO says M&A is harder as acquisition targets become ‘too expensive’ (Food Dive)
- State officials still finding recalled ByHeart infant formula on store shelves (Food Safety News)
- Federal Medicaid audit finds massive overpayment for autism therapy in Colorado (STAT)
- Cigna Elevates COO Evanko to Lead Major Business Model Pivot (Bloomberg)
- CMS halts enrollment in Elevance’s Medicare Advantage plans, citing years of misconduct (STAT)
- CDC acting director Bhattacharya urges use of measles vaccine (Reuters)
- Decentralized Trials Are On ‘Classic Path Of Normalization’ While ‘Solving Real Problems’ (Pink Sheet)
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