Recon: HHS loses court case affecting 340B rebate pilot program; Eli Lilly to acquire Ventyx for nearly $1.2B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Slashing of US vaccine schedule creates new uncertainty on manufacturers’ legal protections (STAT)
- Trump administration 340B pilot program is thwarted, for now, by a US appeals court (STAT)
- Every FDA drug approval in 2025: Number of new treatments dipped during agency upheaval (Endpoints)
- A Busy Day in the (CDRH) Neighborhood: Updates to the CDS and General Wellness Guidance Documents (FDA Law Blog)
- Measles Cases Hit 34-Year High as US Vaccines Norms Crumpled (Bloomberg)
- AstraZeneca names insider Rick Suarez as head of US biopharmaceuticals unit (Reuters)
- OpenAI launches ChatGPT Health to connect user medical records, wellness apps (CNBC)
- Drugmakers brace for Europe pricing fight after Trump's US price-cut deals (Reuters)
- Where’s The Money Gone? England Spends Just 1% Of IMF On Medicines (Pink Sheet)
- UK’s Economic Plans Could See Pharma Firms Move To US, Biotech Founder Warns (Pink Sheet)
- Daiichi taps Genesis to handle commercialization of leukemia med Vanflyta in 13 European countries (Fierce Pharma)
- After shaky years, Mass. life science companies find glimmers of hope (STAT)
- AbbVie denies media reports of talks to buy Revolution Medicines (Reuters)
- Lilly to pay $1.2B for Ventyx and its NLRP3 drugs (Endpoints)
- Omeros prices transplant complication drug at $36,000 per dose (Reuters)
- Parabilis Medicines raises $305 million as CEO warms to an IPO (STAT)
- Ocular Therapeutix faces looming test of a more durable eye treatment (STAT)
- Rune Labs hires Tempus leader as CEO, plots expansion into Alzheimer’s (STAT)
- Former Genentech leaders’ protein degrader startup nets $107M (Endpoints)
- Secretive Rampart Bioscience shuts down after trying to crack non-viral gene therapy (Endpoints)
- FDA rejects Vanda’s jet lag drug following yearslong dispute and 'long-shot' review (Endpoints)
- Obesity biotech Alveus gains $160M for push into MariTide's backyard — and amylins (Endpoints)
- Inside a digital health startup’s experiment to allow AI to refill prescriptions (Endpoints)
- Obesity, M&A, Biotech Revival: A 2026 Guide to Health Stocks (Bloomberg)
- Less than two years after stopping obesity drugs, weight and health issues return, study finds (Reuters)
- Women are celebrating at-home cervical cancer screening, but might it lead them to get fewer checkups? (STAT)
- 4 medtech topics to watch in 2026 (MedTech Dive)
- FDA exempts more wearable, AI features from oversight (MedTech Dive)
- J&J submits FDA de novo request for Ottava robot in general surgery (MedTech Dive)
- Alcon Walks Away From STAAR After Shareholder Revolt, Refocuses On LASIK And Organic Growth (MedTech Insight)
- US FDA’s Sanitized Clinical Trial Guidance Cuts Gender Language (MedTech Insight)
- The Trump Administration killed a draft proposal to halve alcohol limits, sources say (Reuters)
- Panel behind new dietary guidelines had financial ties to beef, dairy industries (STAT)
- Exclusive: The Trump Administration killed a draft proposal to halve alcohol limits, sources say (Reuters)
- Nestle recalls some baby formula in Ethiopia, regulatory body warns consumers (Reuters)
- US dietary guidelines tell Americans to avoid highly processed foods (Food Dive)
- Medicaid restrictions may lead to a million missed cancer screenings over two years: study (STAT)
- Wyden, Warren expand UnitedHealth nursing home investigation (STAT)
- Do Americans expect too much from drugs? (STAT)
- Independent expert group to review HPV vaccine evidence after US recommendation change (Reuters)
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