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March 10, 2025
by Jason Scott

Recon: Novo Nordisk's next-generation obesity therapy falters in diabetes study; Sun Pharma to acquire Checkpoint Therapeutics for $355M

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • On path to likely confirmation as NIH director, Bhattacharya toes the party line (STAT)
  • US FDA to hold off action on weight-loss drug copies pending court ruling (Reuters)
  • Mayo Clinic’s partnership with dairy poses conflict of interest, critics say (STAT)
  • How will the Center for Biologics Evaluation and Research change under RFK Jr.? (STAT)
  • At ‘Stand Up for Science’ rally, Francis Collins warns major NIH research programs ‘at severe risk’ (STAT)
  • Compounders’ motion for preliminary injunction denied in case over tirzepatide shortage (Endpoints)
  • Exclusive: FDA blocks drug and device reviewers from taking HHS' buyout offer (Endpoints)
In Focus: International                                                                                                       
  • Novo Nordisk shares drop after next-gen obesity drug disappoints in diabetes trial (STAT) (Reuters)
  • A U.K. trade group is due to lift its suspension of Novo Nordisk, but critics cite a lack of transparency (STAT)
  • UK MHRA Holds 2025 Device Registration Fee Increase (MedTech Insight)
  • Emergent sells once-troubled manufacturing site to Indian CDMO (Endpoints)
  • Eli Lilly plans to launch weight-loss drug in emerging markets this year (Reuters)
  • India's Syngene International acquires first US biologics facility for $36.5 mln (Reuters)
  • India's Sun Pharma to acquire Checkpoint Therapeutics for $355 million (Reuters)
Pharma & Biotech
  • Mineralys Therapeutics stock soars on blood pressure drug data (STAT)
  • Beam Therapeutics says CRISPR treatment shows encouraging results in lung condition (STAT)
  • BioNTech's shares dip after posting lukewarm revenue guidance (Endpoints)
  • Mired in low expectations, Novo braces for upcoming CagriSema head-to-head trial (Endpoints)
  • J&J, Protagonist outline first IBD win for oral IL-23 with $5B+ sales potential (Endpoints)
  • Trevi’s mid-stage chronic cough data meet ‘home run’ scenario, stock soars (Endpoints)
  • UK's Alliance Pharma accepts DBAY's sweetened final offer (Reuters)
Medtech
  • For Google, health equity becomes ‘health optimization’ as Trump targets DEI (STAT)
  • New Flagship startup aims to trailblaze ‘AI science factories’ (Endpoints)
  • Former an Diagnostics CEO pleads guilty over lead-test device defect (Reuters)
  • New FDA pulse oximetry guidelines could stall under Trump (MedTech Dive)
  • Orthofix’s fired execs’ lewd, ‘graphic’ texts surface in legal battle (MedTech Dive)
  • Dexcom receives warning letter based on FDA inspections of 2 plants (MedTech Dive)
  • The top 3 impacts of Trump’s health data purge (MedTech Dive)
Government, Regulatory & Legal
  • UnitedHealth’s deals and how big hospitals are faring (STAT)
  • Scientists’ suit against top academic publishers lays bare deep frustration over unpaid peer review (STAT)
  • Tariffs will make it even more expensive for Americans to eat healthy (STAT)
  • After-hours CDC email sparked chaos at universities. It turned out to be a mistake (STAT)
  • NIH abruptly terminates millions in research grants, defying court orders (STAT)
  • Doctors push back as parents embrace Kennedy and vitamin A in Texas measles outbreak (Reuters)
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.
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