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)
- 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)
- 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)
- 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)
- 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)
- 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)
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