Recon: J&J, Protagonist tout phase 3 study wins for oral IL-23 therapy; Bayer buys Japanese rights to Cytokinetics’ heart drug

• 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)