rf-fullcolor.png

 

September 9, 2025
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal  
  • 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)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.