Recon: FDA approves Bristol Myers’ schizophrenia drug; Roche targets $3B in annual obesity drug sales
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- J&J backs down on plan to switch payments to some 340B hospitals (STAT)
- J&J, Legend solidify Carvykti's lead in earlier multiple myeloma with strong survival showing (Fierce Pharma)
- Health care CEOs dialed back their pay in 2023. They still made $3.5 billion (STAT)
- Lawmakers call for investigation of former FDA device director (MedTech Dive)
- US FDA approves GE HealthCare's diagnostic drug for heart disease (Reuters)
- US Medicare says Part D and Advantage premiums will fall in 2025 (Reuters)
- Bristol Myers wins US FDA approval for new type of schizophrenia drug (Reuters)
- Sensodyne maker Haleon to raise stake in China JV (Reuters)
- Roche targets more than $3 billion in annual obesity sales (Reuters)
- Grifols plans to invest $402 million in new industrial centre, El Economista says (Reuters)
- UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency (Pink Sheet)
- Moderna rebuked over second successive Spikevax marketing breach (Fierce Pharma)
- Regulatory tracker: Formycon, Fresenius Kabi notch FDA and EU approvals for their Stelara biosimilar (Fierce Pharma)
- Otsuka falls foul of most serious drug marketing breach, again, as Jinarc training site comes under fire (Fierce Pharma)
- A radiopharmaceuticals startup raises $175 million (STAT)
- US FDA approves GE HealthCare's diagnostic drug for heart disease (Reuters)
- DCVC Bio founders look for more quick returns, less overhyped AI, with new $400 million fund (STAT)
- Pfizer to offload about 6% stake in Sensodyne-maker Haleon, says bookrunner (Reuters)
- Steward Health Care CEO Ralph de la Torre will resign (STAT)
- HPV vaccine study finds zero cases of cervical cancer among women vaccinated before age 14 (STAT)
- Prime Medicine shrinks CRISPR ambitions and gets cash infusion from Bristol Myers Squibb (STAT)
- Roche seeks to project confidence on its obesity drugs — and sees room for competition (STAT)
- Why are Genentech cancer researchers worried? (STAT)
- Updated: Roche buys Regor’s CDK inhibitors for $850M upfront amid push to develop 20 ‘transformative’ medicines (Endpoints)
- Poseida shares incremental Phase 1 update for Roche-partnered off-the-shelf CAR-T (Endpoints)
- Kezar halts mid-stage lupus study after four deaths (Endpoints)
- CSPC, Alphamab Oncology make an ADC deal; Visen’s IPO in Hong Kong (Endpoints)
- Rivus details weight loss data in heart failure patients and preps for new fundraise (Endpoints)
- Cereno Scientific details mid-stage results for pulmonary arterial hypertension drug (Endpoints)
- Lundbeck, Otsuka make their Alzheimer’s agitation pitch as Barbara Corcoran joins new campaign (Fierce Pharma)
- US FDA Acknowledges Patient Frustration With CAR-T Boxed Warning (Pink Sheet)
- Sickle cell community scrambles to find safe plan after a drug is pulled from the market (STAT)
- Q&A: Why medical AI and value-based care may be made for each other (STAT)
- Baxter closes dialysis equipment facility due to Hurricane Helene damage (MedTech Dive)
- Establishment Labs wins FDA approval for Motiva breast implants (MedTech Dive)
- What’s next at Masimo after CEO Kiani’s exit? (MedTech Dive)
- Mendaera raises $73M to develop handheld robotics platform (MedTech Dive)
- Bristol Myers beats $6.4 billion lawsuit over delayed cancer drug (Reuters)
- Two reports, two dramatically different views of nonprofit hospitals’ tax breaks (STAT)
- Abbott, Reckitt face trial over premature baby formula amid alarm from doctors (Reuters)
- Knock, Knock. Who’s There? Breakthrough Device. Breakthrough Device Who? Breakthrough Device That Can’t Get to Market (FDA Law Blog)
- CDMOs eye industrywide growth in 2025 as many spurn BIOSECURE Act, CPHI research shows (Fierce Pharma)
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