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May 5, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal
  • 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)
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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