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June 12, 2025
by Jason Scott

Recon: BioNTech to acquire CureVac for $1.25B; FDA approves Urogen’s bladder cancer therapy

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • A closer look at the new members of the CDC vaccine advisory panel (STAT) (Reuters)
  • Exclusive: Kennedy's new vaccine adviser was expert witness against Merck vaccine (Reuters)
  • Braced for details on Trump’s ‘most favored nation’ policy, pharma industry is still waiting (STAT)
  • Video: Trump’s Drug Pricing Order Threatens Investment, Says Roche CEO (The Wall Street Journal)
  • FDA Head Says OxyContin Was Approved Illegally. Now What? (Bloomberg)
  • US CDC restores jobs for 450 laid-off employees (Reuters)
In Focus: International                                                                                                       
  • Australia's Monash IVF CEO quits days after second embryo mix-up in 2 months (Reuters)
  • Capricor gets Form 483 from FDA; WuXi Biologics' new China factory (Endpoints)
  • Trump says tariff deal with China is ‘done’ (MedTech Dive)
  • ‘UK Must Put Adoption On A Par With Innovation’ (MedTech Insight)
  • Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups (MedTech Insight)
  • EUCOPE Wants Simpler Manufacturing Rules & Framework For Combined Trials Under EU Biotech Act (Pink Sheet)
  • Pharma’s Protests Fall Flat As UK Locks In High Rebate Rates (Pink Sheet)
Pharma & Biotech
  • BioNTech to buy CureVac in $1.25 billion deal, saying it will bolster cancer work (STAT)
  • Novo Nordisk plans to start late-stage trials of obesity drug amycretin next year (Reuters)
  • I’m adopted. I still won’t use genetic testing services like 23andMe (STAT)
  • US FDA approves Urogen's bladder cancer drug (Reuters)
  • Cardinal Health boosts profit view banking on specialty drugs unit growth (Reuters)
  • Insmed aims to raise $750M in one of the largest stock offerings this year (Endpoints)
  • Novavax's COVID-flu combo vaccine shows strong immune response in trial (Reuters)
  • Kura, Kyowa say Phase 1 update supports menin inhibitor combos (Endpoints)
  • ADC Therapeutics reveals layoffs, $100M PIPE; Third Harmonic seeks buyer for asset (Endpoints)
  • Schrödinger says early MALT1 data could lay 'great foundation' for combos (Endpoints)
  • Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown (Pink Sheet)
  • David Hung's Nuvation Bio wins FDA approval for Ibtrozi to challenge Pfizer, BMS and Roche in lung cancer field (Fierce Pharma)
Medtech
  • Exclusive: Commons Clinic raises $26M Series B to offer preventive testing (Endpoints)
  • The $7 Billion Nicotine-Pouch Market’s Next Target? Women (Bloomberg)
  • Medtronic recalls ventilators linked to 2 serious injuries, 1 death (MedTech Dive)
  • FDA schedules first public MDUFA VI meeting ahead of negotiations (MedTech Dive)
  • FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers (MedTech Insight)
Food & Nutrition
  • Lab-grown salmon receives FDA approval (Food Dive)
  • How PepsiCo moves past AI pilot purgatory (Food Dive)
  • Trump tariffs could hike canned food prices up to 15%, trade group says (Food Dive)
  • The Use of UV-C Light in Combination With Hydrogen Peroxide to Disinfect Packages in ESL and Aseptic Beverages (Food Safety)
Government, Regulatory & Legal
  • Medicare Advantage’s supplemental benefits will cost taxpayers $86 billion this year, with little transparency (STAT)
  • Medicaid cuts would devastate mental health, substance use treatment services in red states (STAT)
  • RFK Jr.’s Moves Leave Insurance Coverage of Vaccines in Doubt (Bloomberg)
  • Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation (MedTech Insight)
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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