Recon: Trump announces new pricing deals with midsize biotechs; Novartis pauses CAR-T trials after patient deaths
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Trump announces nine new drug pricing deals, this time with midsize biotechs (Endpoints) (STAT)
- Ex-Justice Department official Clint Narver takes over FDA compounding compliance office (Pink Sheet)
- Alar’s ‘conclusory’ safety, efficacy claims for unapproved ketamine draw FDA censure (Pink Sheet)
- FDA dings Alar over ‘extremely concerning’ ketamine claims (Fierce Pharma)
- Oncology firm Novocure says cyberattack exposed US patient records (Reuters)
In Focus: International
- Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused (Endpoints) (Reuters)
- UK regulator suspends Amgen's Tavneos for new patients over unreliable data (Reuters)
- Turkish regulator sets drug naming rules, breaking away from sole EMA reliance (Pink Sheet)
- Roche signs global licensing pact for Simcere's experimental blood cancer drug (Reuters) (Endpoints)
- Ascendis to pay 20% Yuviwel royalties in patent settlement with BioMarin (Fierce Pharma)
- Novo Nordisk launches Wegovy weight-loss pill in Germany (Reuters)
Pharma & Biotech
- Novartis' Rhapsido safer than rivals, phase 3 multiple sclerosis data suggest (Endpoints) (Reuters)
- ARCH Venture Partners targets $3 billion raise for latest fund (Endpoints)
- AstraZeneca-Hutchmed drug combination shows promise in advanced lung cancer study (Reuters)
- GSK to advance mRNA flu vaccine to late-stage trial (Reuters) (Endpoints)
- Alumis eyes late-stage lupus study despite trial miss (Reuters) (Endpoints)
- Sanofi-backed Electra files for IPO to fund Phase 2/3 immunology drug (Endpoints)
- Jazz’s Ziihera secures 2nd survival win to solidify its HER2-positive stomach cancer status (Fierce Pharma)
- K Health is eyeing an IPO by 2029 (Endpoints)
- Moderna’s twisting path to mFlusiva approval strengthened safety defense (Pink Sheet)
- CDMO Lonza hones commercial focus with company vet's return to new role (Fierce Pharma)
Medtech
- Boston Scientific discontinues Imager II catheter, FDA issues early alert over detachment risk (Medtech Insight) (MedTech Dive)
- Kardium receives $31M investment from Canada for manufacturing expansion (MedTech Dive)
- Medtronic boosts fiscal 2027 forecasts on heart device demand (Reuters)
Food & Nutrition
- India busts firm faking expiry dates, nutrition labels on PepsiCo, Nestle food exports (Reuters)
- EU to suspend Brazilian meat imports from September 3, citing antimicrobial rules (Reuters)
- Reckitt shares rebound as Mead Johnson wins infant formula trial (Bloomberg)
- As MAHA champions nutrition, it’s ignoring the experts, dietitians say (STAT)
Government & Legal
- The Trump administration is burying science and health care in paperwork (STAT)
- NIH proposal to cap research grants draws mixed reception, agency says (STAT)
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.
