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November 20, 2025
by Jason Scott

Recon: Abbott to acquire Exact Sciences in $21B deal; Merck KGaA pairs with Valo for AI drug discovery

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Under RFK Jr., CDC reverses course on stance that vaccines don’t cause autism (STAT) (Reuters)
  • Inside RFK Jr.’s first nine months leading HHS (STAT)
  • In new FDA role, Pazdur will decide the future of Sarepta’s Duchenne drugs (STAT)
  • FDA will allow email 'clarifications' after pharma company meetings (Endpoints)
  • New Flu Variant Spreads While Vaccination Rates Fall (Bloomberg)
In Focus: International
  • Flagship and portfolio companies do deals with GSK, Merck KGaA and Saudi Arabia (Endpoints)
  • After Phase 3 hit, Innovent to seek China approval of high-dose obesity shot it got from Lilly (Endpoints)
  • China Boosts South Africa HIV Drive, Huge US Funding Gaps Remain (Bloomberg)
  • Novo Nordisk Powers Denmark’s Fastest Growth in Four Years (Bloomberg)
  • EU health regulator urges immediate vaccinations amid early surge in flu cases (Reuters)
Pharma & Biotech
  • Merck KGaA to draw on Valo's drug discovery AI in potential $3 billion deal (Reuters) (Bloomberg)
  • The anti-aging gold rush should focus on quality of life, not just quantity (STAT)
  • Can GLP-1 drugs treat Alzheimer’s? Novo Nordisk will soon announce key results (STAT)
  • Function Health has won over consumers. When will it publish evidence? (STAT)
  • Aspen gets $115M for Parkinson's cell therapy, potential IPO in sight next year (Endpoints)
  • FDA approves new indication and monthly dose of Regeneron’s Eylea HD (Endpoints)
  • Novartis raises the sales bar for key cancer drugs, tweaks yearly growth guidance (Endpoints)
  • Moderna Gets Breathing Room With $1.5 Billion Loan From Ares (Bloomberg)
  • Bayer Wins US Approval for New Drug Hyrnuo in Lung Cancer (Bloomberg)
Medtech
  • Abbott to buy cancer screening test maker Exact Sciences in $21B deal (STAT)
  • Abbott Inks 2025’s Largest Bridge Loan to Finance Acquisition (Bloomberg)
  • Neuralink Rival Paradromics Cleared to Start Brain Implant Trial (Bloomberg)
  • Roche inks deal for rights to Freenome cancer tests outside US (MedTech Dive)
  • Philips, Edwards team on AI-based guide for mitral valve repair (MedTech Dive)
  • Distalmotion raises $150M to commercialize surgical robot (MedTech Dive)
  • TEAM-NB Spells Out What Needs To Happen When Transferring Legacy Devices (MedTech Insight)
  • Siemens’ 30% Healthineers Spin-Off Signals $23.2 Billion Unwind As Analysts Warn Of Pressure (MedTech Insight)
  • BrainsWay Advances With Expanded Depression Indication, New Alcohol Dependence Trial (MedTech Insight)
  • ResMed’s AirSense 11 Stands To Gain From Philips Recall, But Pricing Risks Remain (MedTech Insight)
Food & Nutrition
  • Tyson to stop selling ‘climate-smart’ beef as part of lawsuit settlement (Food Dive)
  • Lower turkey prices slash Thanksgiving dinner costs in 2025 (Food Dive)
Government, Regulatory & Legal
  • Armed with AI and virtual care, K Health thinks it can make primary care more accessible (STAT)
  • AI spun out of Berkeley proposes to detect hundreds of conditions on medical images (STAT)
  • HHS names authors and releases peer review comments for gender dysphoria report (STAT)
  • AbbVie, Novartis can proceed with legal fight against Utah 340B law (Endpoints)
  • Republican antipathy during key Senate hearing darkens outlook for ACA subsidy extension (MedTech Dive)
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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