Recon: BMS plans $2.3B Houston manufacturing site; MHRA approves Lilly weight-loss drug for weight loss, type 2 diabetes
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Trump demands major changes to childhood vaccine recommendations (Washington Post) (AP) (NYTimes)
- Replimune melanoma drug snags coveted FDA approval after yearlong clash, two rejections (STAT) (FDA)
- FDA to hold adcomm for Grail cancer test that failed in large, randomized trial (Endpoints) (Reuters)
- FDA outlines expedited IND pilot plans, seeking to pick up to 10 programs by year's end (Endpoints)
- US FDA quality management maturity pilot suggests prevention enhances reliability (Pink Sheet)
- Sponsors say NPVP should balance speedy reviews with public trust (Pink Sheet)
- Bristol Myers to build $2.3 billion manufacturing site in Houston (Reuters)
- Judge blocks US decision to add WuXi to list of firms tied to Chinese military (Reuters)
In Focus: International
- Lilly's weight-loss pill gets UK regulator's nod (Reuters) (MHRA)
- Medtronic gets CE mark for ablation to treat ventricular tachycardia (MedTech Dive)
- Lewy body dementia drug neflamapimod wins UK innovation passport after phase 2 hurdle (Pink Sheet)
- CSL and Arcturus split up (Endpoints)
- Congo's Ebola outbreak surpasses 4,000 cases (Reuters)
- CEPI points developers to 45 African trial sites in race for Bundibugyo vaccine (Pink Sheet)
- China’s new five-year plan signals shift to quality and innovation (Medtech Insight)
- Is European withdrawal of Tavneos the start of a global regulatory reckoning? (Pink Sheet)
- Thermo Fisher eyes 15%-20% India customer growth on biopharma research, manufacturing boost (Reuters)
Pharma & Biotech
- Medicare quietly gave blockbuster AbbVie drug seven extra years before price negotiations, advocacy group asserts (STAT)
- Silence Therapeutics aims at Takeda with new data in rare blood cancer (STAT)
- Jazz bets on epilepsy treatment with up to $1.32 billion deal for Actio (Reuters)
- A shortage of two Sanofi medicines for Pompe disease rattles patients (STAT)
- Medicare codifying eligibility reset that delayed price negotiation for ‘deemed’ biologics (Pink Sheet)
- Sionna’s experimental cystic fibrosis pill falls flat in mid-stage trial, scraps drug program (STAT) (Reuters)
- Tenax heart drug fails to improve walking results in pivotal study (STAT) (Reuters)
- Scholar Rock drops Novo Nordisk facility from marketing application for muscle weakness drug (Reuters)
- BioMarin axes asset from $270M Inozyme takeover, ending run in rare metabolic indication (BioSpace)
- BlossomHill, Latigo cap four-IPO week with combined $496M haul (Endpoints)
- China tightens the reins on clinical trials, even as the US looks for ways to replicate its rival’s speed (STAT)
Medtech
- Philips forms 6 patient monitoring partnerships (MedTech Dive)
- ResMed shares tumble as weak 2027 sales forecast eclipses quarterly profit beat (Reuters)
- Solventum plans software separation to become ‘true medtech company’ (MedTech Dive)
- Polen touts ‘new BD,’ product innovation as company raises 2026 earnings outlook (Medtech Insight)
- Zimmer Biomet sales force revamp going better than expected, CEO says (MedTech Dive)
- EU PPWR’s two-role split creates costly compliance trap for device makers (Medtech Insight)
- Clinicians want better battery-life indicators in pacemakers and ICDs, AAMI survey finds (Medtech Insight)
Food & Nutrition
- FDA to require notice of additives in food supply for the first time (STAT) (HHS)
- Taylor Farms recalls salsa and guacamole from Walmart, Kroger over salmonella risk (Reuters)
- Michigan eases lettuce advice as state health department says cyclosporiasis reports decline (Reuters)
Government & Legal
- Trump administration considers order on autism and vaccines (Reuters)
- NIH plans to block international researchers on visas from accessing key funding avenue (STAT)
- ‘An early warning map’: Lawyer explains EU animal phase out roadmap (Pink Sheet)
- Judge signs off on Teva's $35M settlement over delayed inhaler generics (Endpoints)
- Senate bill emerges, adding pressure on Treasury to screen China biotech deals (Endpoints)
- RESULTS Act picks up more bipartisan support as Medicare lab payment reform push continues (Medtech Insight)
- Second time’s the charm: HRSA revives the 340B rebate pilot (FDA Law Blog)
- Republican US Senator Rand Paul asks Justice Department to prosecute Fauci after contempt vote (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.