Recon: J&J, Protagonist tout phase 3 study wins for oral IL-23 therapy; Bayer buys Japanese rights to Cytokinetics’ heart drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- The many legal fronts of RFK Jr.’s fight against vaccines (STAT)
- Two drugs look promising for lipoprotein(a), a common genetic risk factor for heart disease (STAT)
- The FDA’s risky action on compounding weight loss drugs (STAT)
- In first meeting of FDA’s digital health advisory committee, generative AI is up for debate (STAT)
- Lawmakers are poking holes in pharma's favorite new way to market medicines (Endpoints)
- J&J, Protagonist reveal two Phase 3 wins for oral IL-23 drug that's expected to be a blockbuster (Endpoints)
- Merck says Keytruda injection on par with approved IV version in trial (Reuters) (STAT)
- Pharma still ‘falling short’ in providing access to low- and middle-income countries, analysis finds (STAT)
- H5N1 bird flu virus in Canadian teenager displays mutations demonstrating virus’ risk (STAT)
- Bayer acquires rights to Cytokinetics' heart drug in Japan (Reuters) (Endpoints)
- EMA Urges Variation Submissions By 30 November Before Holiday Closure (Pink Sheet)
- EMA Says No To Extending Clock-Stops For Immature Marketing Applications (Pink Sheet)
- China Opens Up Non-End-To-End Manufacturing Of Biologics Within, Across Border (Pink Sheet)
- England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo (Fierce Pharma)
- GSK drug meets main goal in late-stage study to treat relentless itch (Reuters)
- A win for Apellis, a setback for Astellas (STAT)
- Bristol Myers takes on autoimmune diseases with cell therapy, plus new data from Cabaletta and Kyverna (Endpoints)
- Lilly’s oral cardio drug that blocks lipids passes mid-stage test (Endpoints) (Reuters)
- Former NCI chief and serial biotech entrepreneur raise $70 million to start companies that fail fast (STAT)
- Incyte’s bet on Escient hits a snag as safety issues hamper Phase 2 chronic hives trial (Endpoints)
- Exclusive: Synapticure raises $25M for its approach to virtual neurodegenerative disease care (Endpoints)
- Exact Sciences ramps up colon cancer outreach to Hispanic community with Carlos Ponce partnership (Fierce Pharma)
- Why the crowded market for ambient AI medical scribes might be ripe for consolidation (STAT)
- Medtronic lifts annual profit view on steady demand for medical devices (Reuters)
- Medtronic’s ablation sales slowed by PFA supply issues (MedTech Dive)
- Abbott opens plant in Ireland to boost Libre 3 sensor production (MedTech Dive)
- The PFA race is heating up. Here’s where the market stands after J&J’s approval (MedTech Dive)
- Smart ring maker Ōura valued at over $5 bln after Dexcom funding (Reuters)
- Boston Scientific’s Watchman could be new option for patients post ablation: study (MedTech Dive)
- First U.S. case of new mpox strain detected in California (STAT)
- Exclusive: Activist investor Ananym Capital pushes for changes at Henry Schein, sources say (Reuters)
- Gene/Cell Therapies: US FDA Clarifies INTERACT, Pre-IND Meeting Timing In FAQ Guidance (Pink Sheet)
- FDA warns providers on Getinge devices tied to 17 serious injuries (MedTech Dive)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
