Recon: GSK to buy Nuvalent for $10.6B; Pentagon labels WuXi AppTec as linked to Chinese military
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Cancer vaccines based on mRNA advance, despite US cuts (Reuters)
- Trump’s health care affordability czar touts Medicaid cuts to hospital leaders (STAT)
- FDA expands sunscreen options with first new ingredient since 1990s (Reuters)
- US NIH names John Powers III as acting director of infectious disease institute (Reuters)
- Long Live the Skinny Label (FDA Law Blog)
In Focus: International
- Health workers at the epicenter of Congo’s Ebola outbreak labor with little pay or rest (STAT)
- WuXi AppTec added to Pentagon list of companies linked to Chinese military (Endpoints)
- Roche sticks to German investment after Eli Lilly cuts (Reuters)
- Europe faces growing synthetic opioids risks as drug market evolves, EU agency warns (Reuters)
- Gavi plans to use US cash for malaria, while meeting Kennedy's conditions (Reuters)
- India’s Top Bank in $1 Billion Funding for Sun Pharma’s US Deal (Bloomberg)
- Indian cancer patients battle shortage of key drugs as platinum costs surge (Reuters)
- Growing Use of External Controls Prompts EMA Push for Clarity (Pink Sheet)
- UK's Boots in talks for $10 billion sale as owners plan to scrap IPO plans, FT reports (Reuters)
Pharma & Biotech
- GSK to buy Nuvalent, maker of targeted cancer drugs, for $10.6B (STAT)
- Trodelvy misses again in lung cancer, but Gilead and Merck have an HIV success to soften the blow (Endpoints)
- AlzeCure signs collaboration, out-licensing deal with Lilly for Alzheimer's drug (Reuters)
- AstraZeneca's obesity pill matches rivals in Phase 2, anchoring $5B franchise push (Endpoints)
- Use of GLP-1 drugs early in pregnancy should not cause alarm, analysis suggests (Reuters)
Medtech
- Wearables, and the flood of data they generate, inch closer to entering the clinic (STAT)
- Medtronic set for Stealth AXiS expansion in Europe (MedTech Dive)
- Dexcom bolsters evidence for glucose sensors for Type 2 diabetes (MedTech Dive)
- Boston Scientific to build Indiana distribution center (MedTech Dive)
- AI Is Going From ‘Abstract To Practical’ For Clinicians, Says Philips’ Future Health Index (MedTech Insight)
- From Genome To RUO In Six Days: Roche’s Playbook For Rapid Outbreak Diagnostics (MedTech Insight)
Food & Nutrition
- Alcohol study discarded by Trump officials is published in scientific journal (STAT)
- A $395 pineapple? How innovation is upending the popular tropical fruit (Food Dive)
Government, Regulatory & Legal
- Ending animal testing could set back xenotransplantation just as the field is poised for a breakthrough (STAT)
- The Broken Backbone of America’s Healthcare System (Bloomberg)
- Lawmakers promised cancer patients would be protected from Medicaid cuts. Now CMS says otherwise (STAT)
- Who pays the best (and worst) in biopharma? A look at typical employee salaries (ST AT)
- MFN Deals Post-Trump: Launch Price Parity Would Be Hardest To Undo (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.
