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June 2, 2025
by Jason Scott

Recon: Sanofi to acquire Blueprint in $9B deal; FDA approves Moderna’s next-gen COVID vaccine for older adults

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

In Focus: US
  • The shrewd startup founder who led DOGE’s cost-cutting at HHS (STAT)
  • Phase 3 or bust: Why Lilly won't run mid-stage cancer trials (Endpoints)
  • Sanofi to buy Blueprint Medicines in deal worth more than $9 billion (STAT)
  • mRNA, once lauded as a scientific marvel, is now a government target (STAT)
  • US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older (Reuters)
  • Musk's Neuralink raises $650 million in latest funding as clinical trials begin (Reuters)
In Focus: International                                                                                                       
  • Sanofi’s vaccine tech transfer in Vietnam; Almac’s £1B+ revenue milestone (Endpoints)
  • Korean startup Curogen seeks global expansion, new funding to back autoimmune drugs (Endpoints)
  • Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs (MedTech Insight)
  • Japan Price Cuts For Epkinly and Lunsumio Following CEA (Pink Sheet)
Pharma & Biotech
  • Bristol Myers to partner with BioNTech on experimental cancer drug (STAT)
  • Enhertu, used as first option, stalled tumors for more than a year in women with breast cancer, study finds (STAT)
  • Kymera reports early-stage success for drug meant to rival Sanofi and Regeneron’s Dupixent (STAT)
  • Vera Therapeutics reports positive results from trial of kidney disease drug (STAT)
  • Atai Life Sciences plans to merge with psychedelic startup Beckley Psytech (STAT)
  • AstraZeneca’s CEO balances cancer-fighting opportunities with political uncertainty (STAT)
  • Defying death two years after brain cancer diagnosis: studies build hope in CAR-T (STAT)
  • In race with Merus, Bicara makes the case for two-year survival data (Endpoints)
  • AstraZeneca details its oral SERD 'switching' regimen as feasibility questions remain (Endpoints)
  • Regeneron's weight-loss drug combo helps preserve muscle in study (Reuters)
  • Amgen drug cuts small cell lung cancer death risk by 40% (Reuters)
  • Gilead's CAR-T cell therapy shows promise in deadly brain cancer (Reuters)
Medtech
  • FDA plans to begin rolling out AI tool agency-wide on Tuesday (STAT)
  • Bivacor wins FDA breakthrough nod for titanium total artificial heart (MedTech Dive)
  • Beta Bionics CEO, CFO on how to take a company public (MedTech Dive)
  • Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System (MedTech Insight)
  • SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US (MedTech Insight)
Food & Nutrition
  • Candy makers worry timeline to remove artificial dyes too ‘aggressive’ (Food Dive)
  • JBS USA to build $135M sausage plant in Iowa (Food Dive)
  • Nestlé, Mondelēz leave the US Plastics Pact (Food Dive)
  • AFIA Decries ‘Oversimplification’ of Claims in MAHA Report (Food Safety)
Government, Regulatory & Legal
  • Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier (STAT)
  • FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures (MedTech Insight)
  • Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo (Pink Sheet)\
  • US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE (Pink Sheet)
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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