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)
- 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)
- 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)
- 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)
- 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)
- 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)
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