Recon: Novartis to buy Tourmaline for $1.4B; Trump could offer carve-outs for pharma in future trade pacts
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Vaccine policy threatens to put Kennedy at odds with Trump (STAT)
- Trump may exempt some pharma products from tariffs in future trade deals (Endpoints)
- Regeneron patent deal with Sandoz clears path for new Eylea biosimilar launch in 2026 (Endpoints)
- New FDA approval pathway for n-of-1 therapies coming soon, Prasad says (Endpoints)
- US Hasn’t Started Writing Autism Report, FDA Leader Says (Bloomberg)
- Internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify (FDA Law Blog)
- MAHA report on US children's health targets food and drug marketing (Reuters)
- US FDA deems Sun Pharma's Halol plant not compliant with its manufacturing rules (Reuters)
- EU Critical Medicines Act: Parliament Clarifies ‘Significant Proportion’ Rule (Pink Sheet)
- UK To Formalize ‘Research As Care’ Concept To Boost Clinical Trial Participation (Pink Sheet)
- Switzerland’s swissdamed UDI Goes Live Ahead Of 2026 Mandatory Compliance (MedTech Insight)
- Without A Delayed EU AI Act Application, Medtech Could Be Derailed Again (MedTech Insight)
- Pricing group says weight-loss drugs becoming more cost-effective (Reuters) (STAT)
- Novartis to buy Tourmaline Bio, gaining promising heart medicine (STAT)
- Lilly's blood cancer drug shows promise in trial as early treatment (Reuters)
- Lilly will let small biotechs use its AI models at no cost (STAT) (Reuters)
- Ideaya touts trio of cancer drugs as it eyes spot in precision oncology market (Endpoints)
- Regeneron’s promising antibody for cat, birch allergies; Ascletis targets quarterly GLP-1 shot (Endpoints)
- Bertozzi-advised Ridge Bio lands $25M to help drugmakers come up with better ADCs (Endpoints)
- Summit plays defense for the first time as questions loom over Phase 3 lung cancer readouts (Endpoints)
- Pfizer reports new Covid-19 vaccine data after defending the product (Endpoints)
- Previous CT scans may increase pregnancy risks (Reuters)
- Pulse wins IDE approval; Galvanize pulls in $100M (MedTech Dive)
- Microbot receives 510(k) clearance for endovascular robot (MedTech Dive)
- Investors Want Proof of Big Tech’s AI Progress (Bloomberg)
- Salmonella linked to home-delivery meals sold in 10 states: CDC (The Hill)
- Campbell’s company says it will stop using artificial food dyes (Food Safety News)
- Bringing AI to medicine requires philosophers, cognitive scientists, and ethicists (STAT)
- Epic must face claims it used monopoly power to harm a rival business, judge rules (STAT)
- Former top FDA digital leader lands at Mayo Clinic (STAT)
- What states will be next to end school vaccine requirements? (STAT)
- UnitedHealth sees 78% of members in high-rated Medicare plans (Reuters)
- FCA Enforcement Shows No Signs of Slowing, Attorney Tells Medtech Companies (MedTech Insight)
- Doctors group recommends COVID-19 vaccine for all adults in break with government (The Hill)
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