Recon: Supreme Court won’t review Oklahoma PBM law; Senate passes megabill after marathon voting session
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Supreme Court declines to review Oklahoma law regulating PBMs (STAT)
- HHS to continue funding cancer prevention, tracking work in states after uncertainty (STAT)
- Vance breaks 50-50 tie as Senate passes GOP megabill after voting around the clock (The Hill)
- House committee subpoenas Pfizer executive in probe of alleged Covid vaccine delay (CNN)
- AstraZeneca CEO wants to move listing to the US (The Times of London)
In Focus: International
- European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway (MedTech Insight)
- EU approves Vertex's next-generation cystic fibrosis drug (Reuters)
- China's Innogen expects to complete weight-loss drug trials next year (Reuters)
- China Enlists Commercial Insurers in Bid to Boost Local Biotechs (Bloomberg)
- Torrent Pharma shells out $1.4B to take over controlling stake in India's JB Pharma from KKR (Fierce Pharma)
Pharma & Biotech
- Sage Therapeutics cuts most of its workforce following acquisition (STAT)
- Lessons from Duke’s nuked mega cord blood deal with Cryo-Cell (STAT)
- How Novo Nordisk misread the US market for its weight loss sensation (Reuters)
- Advocates urge J&J to ‘put everything on the table’ for gene therapy despite failed trial (Endpoints)
- Kevin Tang's Concentra snags another buyout, this time for IGM Biosciences (Endpoints)
- Unnatural Products taps argenx's help for ringed molecules, expands internal work into obesity (Endpoints)
- Pfizer ends Phase 2 trial for final Trillium CD47 drug (Endpoints)
- Exclusive: Sama Fertility raises $3.8M to make IVF more accessible (Endpoints)
- How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths? (Pink Sheet)
- FDA weighs regulatory action on argenx's Vyvgart Hytrulo amid reports of 'severe worsening' of disease (Fierce Pharma)
Medtech
- Who benefits from over-the-counter CGMs? (MedTech Dive)
- Carmat files for insolvency amid cash crunch (MedTech Dive)
- New glucose sensors, insulin patch pumps lead ADA’s Scientific Sessions (MedTech Dive)
- Olympus pledges prompt response following FDA import block (MedTech Dive)
- Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring (MedTech Insight)
- Brainlab CEO in internal memo blames geopolitical uncertainties for putting IPO on ice (Reuters)
Food & Nutrition
- Conagra Brands to Remove FD&C Colors from U.S. Frozen Product Portfolio by End-2025 (Food Safety)
Government, Regulatory & Legal
- RFK Jr. says he has a team working on changes to the vaccine injury compensation program (STAT)
- UnitedHealth, Sloan Kettering Resolve Contract Dispute (Bloomberg)
- US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber (Pink Sheet)
- Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews (Pink Sheet)
- SCOTUS ruling paves smooth launch path for Gilead's long-acting PrEP med Yeztugo, analyst says (Fierce Pharma)
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.
