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January 8, 2026
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal
  • 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
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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