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October 21, 2025
by Jason Scott

Recon: CBO estimates orphan drug exemptions will cost Medicare $3.9B; Blackstone, TPG take Hologic private in $18.3B deal

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Government shutdown means many CDC experts are skipping a pivotal meeting on infectious disease (STAT)
  • CBO says revised cost of orphan drug exemptions will add $3.9 billion to Medicare (STAT)
  • FDA review of drugs is slowing while application delays are growing, analysis finds (STAT)
  • CRISPR Therapeutics says its new gene editing tool is 'a significant advance' over prime editing. Prime Medicine disagrees (Endpoints)
  • FDA staffing data show historic numbers of departures in fiscal 2025 (Endpoints)
  • Novo Nordisk fights to keep Medicaid paying for weight-loss drugs (Reuters)
  • Hologic to go private in up to $18.3 billion deal backed by Blackstone, TPG (Reuters)
In Focus: International                                                                                                       
  • A chemistry startup in Scotland raises over $50M Series B to scale its ‘chemputers’ (Endpoints)
  • WHO says India has much to do on toxic cough syrup despite some progress (Reuters)
  • EU weighs ban on ethanol used in hand sanitisers over cancer fears, FT reports (Reuters)
  • France raises bird flu alert level to 'high' after new cases (Reuters)
  • Novo Nordisk's top investor seizes board control in weight-loss drug battle (Reuters)
  • German Pricing System Is Tougher On Drugs Targeting Smaller Patient Populations (Pink Sheet)
  • Persistence Pays Off: New International Clinical Evaluation Standard Is Finally On Horizon (MedTech Insight)
  • Ending polio still possible, health officials say, as funding cut by 30% (Reuters)
Pharma & Biotech
  • Is a battle brewing between Abridge and OpenEvidence? (STAT)
  • Novo Nordisk’s chair to step down (Endpoints)
  • Galapagos to exit cell therapy, with loss of 365 jobs and global sites to shutter (Endpoints)
  • 'Decade of the ADCs' continues as AstraZeneca, Kelun and Merck take the stage at ESMO (Endpoints)
  • Summit plans to take lung cancer drug to FDA, plots combo use and study changes (Endpoints)
  • Celcuity’s shares rally after ESMO readouts; Disc Medicine’s $220M stock sale (Endpoints)
Medtech
  • Duke data scientist launches startup to help hospitals adopt AI (STAT)
  • AMA wades into turbulent debate over AI regulation with new digital health center (STAT)
  • Danaher tops quarterly estimates as diagnostic momentum builds (Reuters)
  • Quest Diagnostics raises annual profit and revenue forecasts on lab test demand (Reuters)
  • Biolinq’s Jared Tangney on making CGMs unintimidating (MedTech Dive)
  • MDMA warns Section 232 tariffs could hurt US medtech manufacturing (MedTech Dive)
  • Walmart to be first US retailer to sell Abbott's continuous glucose monitor (Reuters)
Food & Nutrition
  • Nestlé leaves climate alliance focused on reducing dairy methane emissions (Food Dive)
  • CPGs and suppliers discuss the ‘magic’ of melding food packaging design with policy (Food Dive)
Government, Regulatory & Legal  
  • The origins of Covid and public health’s uncertainty problem (STAT)
  • 10x sues rival Illumina over gene-sequencing patents (Reuters)
  • Kaiser Permanente, DOJ nearing resolution in $1 billion Medicare fraud case (STAT)
  • CMS says it’s cutting fraud. Patients like me may pay the price with our lives (STAT)
  • US Supreme Court won't revive mumps vaccine antitrust case against Merck (Reuters)
  • Where Have All the Good Guidance Gone? (FDA Law Blog)
  • Local health leaders rebuke federal vaccine policy (The Hill)
  • The FDA’s Mifepristone Decision Has Baffled Both Sides (Bloomberg)
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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