Recon: FDA to convene adcomm for Capricor's DMD therapy; Trump wants drugmakers to agree to lower prices to offset tax cuts
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- As financial prospects for gene therapies dim, an ambitious charity picks up the torch (STAT)
- Scientists question NIH project’s use of 20th century technology to make a universal flu vaccine (STAT)
- FDA will ask outside experts to review Capricor’s therapy for Duchenne muscular dystrophy (STAT)
- Exclusive: US FDA asks some fired pharma user fee negotiation staff to return (Reuters)
- Trump Seeks to Squeeze Drugmakers’ Revenues to Pay for Tax Cuts (Bloomberg)
- What Counts as ‘New Vaccines’ for RFK Jr.’s Placebo Testing Order? (Bloomberg)
- Trump 'shows an openness' to Medicaid work requirements, committee chair says (Reuters)
- Pope Francis's popemobile set to become health clinic for Gaza children (Reuters)
- Early bits of in vivo CAR-T human data emerge from biotech trials in China (Endpoints)
- MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains (MedTech Insight)
- What The EMA Can Teach HTA Bodies About Joint Clinical Assessments (Pink Sheet)
- Novo Nordisk strikes telehealth deals for obesity drug, following Eli Lilly (STAT)
- BioNTech says Novartis executive Zapata-Gomez to become CFO (Reuters)
- Zimmer Biomet lowers 2025 profit forecast on acquisition costs, tariff uncertainty (Reuters)
- Exclusive: Deerfield secures $600M+ for third healthcare venture fund to seed new companies (Endpoints)
- Recursion cuts nearly half of its pipeline, including its most advanced program (Endpoints)
- AbbVie’s Skyrizi retakes top TV ad spending spot for the first time all year (Fierce Pharma)
- BioNTech, gearing up for cancer drug approval filing, works to diversify supply base (Fierce Pharma)
- A court decision on lab-developed tests sets a dangerous precedent (STAT)
- Hims Taps Amazon Vet to Lead Operations as Company Expands (Bloomberg)
- Henry Schein misses quarterly revenue estimates on weak demand for dental products (Reuters)
- Iambic debuts next version of AI model Enchant, driving new way for drug R&D (Endpoints)
- Trump policies are upending healthcare. Track the effect on the medtech industry here. (MedTech Dive)
- Cardinal Health cuts employees to offset up to $300M tariff charge (MedTech Dive)
- Intuitive wins new FDA nod for single port robot; Resmed buys diagnostic facility (MedTech Dive)
- Stryker expects $200M tariff hit, lowers earnings forecast (MedTech Dive)
- New Treatment For Chronic Facial Pain Could Launch By Fall 2025 (MedTech Insight)
- 5 food experts making sense of MAHA’s vision for a new way of eating (STAT)
- White House FY2026 Budget Request Includes Sparse Details on 'MAHA' Food Safety (Food Safety)
- FAO Report Examines Potential Safety Concerns Associated with Supplements, Functional Foods (Food Safety)
- CVS Health’s Aetna to abandon Affordable Care Act insurance marketplaces, again (STAT)
- At AACR, leading cancer researchers urge colleagues to ‘fight for your science’ (STAT)
- Overseas grants could be ‘closed down’ by NIH under new policy, internal email suggests (STAT)
- Hospitals and patient groups ramp up opposition to Medicaid cuts as House mulls options (STAT)
- Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources (MedTech Insight)
- After striking out in bankruptcy court, Johnson & Johnson goes after expert witness in talc cases (Fierce Pharma)
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