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May 15, 2025
by Jason Scott

Recon: Kennedy defends HHS cuts in contentious hearing; FDA approves Amneal’s self-administered migraine therapy

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

In Focus: US
  • In combative hearings, Kennedy defends HHS cuts, backtracks — and lashes out (STAT)
  • Former FDA head Robert Califf says RFK Jr.’s vaccine rhetoric is ‘doing harm’ to Americans (STAT)
  • Ensuring most-favored nation drug pricing doesn’t sicken us (STAT)
  • Drug compounder Empower was built on risky shortcuts, ex-employees and inspections allege (Endpoints)
  • US FDA approves Amneal's self-administered migraine treatment (Reuters)
In Focus: International                                                                                                       
  • WHO trims top management ranks amid financial crunch (STAT)
  • French trial sponsors are urged to bolster clinical trial transparency (STAT)
  • South Africa has no plan to replace US HIV funds yet, minister says (Reuters)
  • Waters Corp's India business boosted by rush for weight-loss drugs (Reuters)
  • Merck KGaA cautious on 2025 profit on currency effects, tariff uncertainty (Reuters)
  • Exclusive: HIV patient testing falls in South Africa after US aid cuts (Reuters)
  • Abbott India's quarterly profit climbs 28% on strong demand (Reuters)
  • European Commission readies countermeasures to US tariffs (MedTech Dive)
Pharma & Biotech
  • Investment firm RA Capital lays off incubator staff amid industry instability, push into China (STAT)
  • Day 1 at ASGCT: Missing scientists, a gene editing failure, and a gene editing first (STAT)
  • Eli Lilly and AstraZeneca top a consultancy’s ranking of drug company R&D (STAT)
  • Prenatal genetic therapy for SMA shows promise in a mouse study (STAT)
  • What to know about Summit Therapeutics’ looming clinical trial readout (STAT)
  • Novo Nordisk strikes deal with Septerna to develop obesity pills (STAT)
  • Exclusive: Datavant to acquire real-world data specialist Aetion, doubling life sciences team (Endpoints)
  • Pathos AI collects $365M to fuel 'bulletproof' oncology trials and in-license more cancer drugs (Endpoints)
  • FDA Begins Granting Advanced Manufacturing Technology Designations (FDA Law Blog)
  • Biohaven stock sinks on three-month delay for neuro drug's FDA approval decision (Endpoints)
  • Enliven stops work on solid tumor drug; Pulmatrix to divest assets (Endpoints)
  • AGC Bio secures lentiviral contract; Thermo Fisher to make Cybin asset (Endpoints)
Medtech
  • As AI in health care proliferates, so do legal questions concerning its use (STAT)
  • Exclusive: 17 health systems are working with Abundant Venture Partners to develop tech (Endpoints)
  • AdvaMed CEO Scott Whitaker pleads for tariff relief in Senate hearing (MedTech Dive)
  • Philips taps Nvidia to build AI model for MRI (MedTech Dive)
  • A Deregulated Medtech Sector Could Flourish In Merz’s Industry-Friendly Germany (MedTech Insight)
Food & Nutrition
  • Tariffs are slowing ‘what was an active M&A pipeline’ for Post Holdings (Food Dive)
  • Coca-Cola to update recycling labels following EU greenwashing complaint (Food Dive)
  • Food Safety and Regulatory Aspects of State EPR Programs (Food Safety)
Government, Regulatory & Legal
  • Scientific societies call for a moratorium on using CRISPR to create genetically modified children (STAT)
  • Projected number of uninsured from GOP’s bill is nearing levels not seen since ACA repeal effort (STAT)
  • Drug overdose deaths fell sharply in 2024, as fentanyl cases dropped but meth spiked (STAT)
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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