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)
- 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)
- 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)
- 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)
- 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)
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