Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Tempus to buy cancer test maker Personalis for $1.5 billion (Reuters)
- A most-wanted fugitive appears to have been secretly working as a biotech executive (STAT)
- Midsized biotechs take case against CMS' GLOBE and GUARD models to White House (Endpoints)
- US FDA Medical Policy Council’s Role In Breakthrough Therapy Designations Reduced (Pink Sheet)
- US FDA Feeling Layoff Impact? NDA/BLA First Half Approvals Down, But H2 Traditionally Better (Pink Sheet)
In Focus: International
- UK biotech VC funding rebounds and reaches record high (Endpoints)
- Novo Nordisk to launch lower-cost Ozempic copy in South Africa (Reuters)
- Japanese drugmaker Takeda's Qdenga becomes first dengue vaccine approved in India (Reuters)
- Scholar Rock says EU opinion on SMA drug may be pushed to later in 2026 (Reuters)
- SPC Extension Or Not, Europe Must Prove It Can Deliver Returns (Pink Sheet)
- European Commission Sets Expectations On Joint Clinical Assessment AI Use (Pink Sheet)
- Aspen Pharmacare wins Canada approval for generic Ozempic after Novo patent expiry (Reuters)
Pharma & Biotech
- J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal (Endpoints)
- Bristol Myers says it will build pharma's 'most powerful' AI supercomputer with Nvidia (Endpoints)
- Can the shingles vaccine prevent Alzheimer’s? GSK has a big study to find out (Endpoints)
- Celcuity got its cancer drug approved. Then its stock dipped (Endpoints)
- Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs (Endpoints)
- GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout (Endpoints)
- Novartis faces drug pipeline test with valuation premium in focus (Reuters)
- Samsung Biologics to launch $1.8 billion all-cash bid for PolyPeptide (Reuters)
Medtech
- Resmed ventilator safety issue linked to 5 serious injuries (MedTech Dive)
- Abbott discloses cyberattack on cancer diagnostics business (MedTech Dive)
- Intuitive ties Q2 procedure softness to ACA subsidy expirations (MedTech Dive)
- Medtronic completes SPR Therapeutics acquisition (MedTech Dive)
- Large funding rounds help boost digital health investment in H1 (MedTech Dive)
- Intuitive Surgical Posts Strong Q2 Revenues, Moves Into GI Endoscopy With FDA Submission (MedTech Insight)
- Edwards, Genesis To Pay $12M To Settle FTC Claims TAVR-AR Deal Sidestepped Reporting Rules (MedTech Insight)
- Abbott Bets $21bn Exact Sciences Unit Will Help Speed Growth As Bigger CGM Prize Waits On Medicare (Meditech Insight)
Food & Nutrition
- US FDA says data continues to support Taylor Farms' lettuce as cyclospora source (Reuters)
- Taylor Farms, Sysco pull iceberg lettuce from central Mexico linked to US parasite outbreak (Reuters)
Government, Regulatory & Legal
- Quitting smoking is hard. A Medicare change may push doctors to give more help (STAT)
- State audit of Medicaid records points to methods used by PBMs to obscure drug costs (STAT)
- CMS Signals Tighter Pass-through Eligibility As Breakthrough Devices Dominate Applications (MedTech Insight)
- It’s time to treat pandemics as threats to national security (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.
