Recon: FDA approves Kura-Kyowa blood cancer drug; Pfizer completes Metsera acquisition

• FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s (STAT) (Endpoints) (Reuters)
• Pazdur vs. Prasad: Can the CDER-CBER dynamic change under new leadership? (Endpoints)
• US FDA approves Kura-Kyowa's blood cancer therapy (Reuters)
• Lilly Drops CVS Drug Plan for Workers After Novo Deal (Bloomberg)
• Merck KGaA still in tariff talks with the White House, weeks after deal was announced (Endpoints)
• Pfizer completes up to $10 billion acquisition of Metsera (Reuters)
• Congratulations: The Shutdown Left Health Care’s Mess Intact (Bloomberg)
• US vaccine panel may vote on hepatitis B shots in December (Reuters)

• Chinese biotechs are shedding their fast-follower reputations as innovation surges (Endpoints)
• WuXi AppTec plants 'flag down' in Europe with new Munich headquarters (Endpoints)
• Africa experiencing worst outbreak of cholera in 25 years, Africa CDC says (Reuters)
• Why has wild polio been found in Germany and what does it mean? (Reuters)
• EUDAMED Official Readiness Notice Due Any Day (MedTech Insight)
• US proposal to halve biosimilar development costs for India's Biocon, top exec says (Reuters)
• Tuberculosis rates fall for the first time since COVID-19 pandemic, WHO report (Reuters)

• Q&A: BioNTech co-founders discuss bispecific efforts, Bristol Myers deal, and the irony of competing with Pfizer (Endpoints)
• Inside Moderna’s rapid rise — and precarious future (STAT)
• AbbVie cuts ties with Google-backed longevity company, lays off scientists (STAT)
• Alkermes shares tumble as sleep disorder drug shows limited advantage over rival (Reuters)
• Uniqure’s CEO dined with investors. Here’s what he said (STAT)
• Why is Eli Lilly worth nearly $1 trillion? (STAT)
• Q&A: Brent Saunders on pushing Bausch out of neutral, scrutinizing new hires and why TrumpRx matters (Endpoints)
• Korro Bio abandons lead genetic disease drug candidate after disappointing data (Endpoints)
• Zealand pauses development of GLP-1/GLP-2 obesity candidate (Endpoints)
• Novartis says Phase 3 data prove new antimalarial could address resistance (Endpoints)
• Gate Bioscience captures another $65M with new take on protein degradation (Endpoints)
• The Fight to Save the $2.7 Billion Botox Empire (Bloomberg)
• Mangoceuticals partners with Lilly, Novo Nordisk to sell weight-loss drugs (Reuters)
• 'Not been pretty': Novo Nordisk faces rare shareholder rebuke over board shake-up (Reuters)
• WeightWatchers to offer Novo Nordisk's Wegovy pill after 2026 launch (Reuters)

• Mental health companies, once wary of AI, are building chatbots (Endpoints)
• Stereotaxis nets FDA clearance for redesigned surgical robot (MedTech Dive)
• Medtech VC funding slows in Q3: PitchBook (MedTech Dive)
• BD Names First CRO To Drive Commercial Overhaul As ’New BD‘ Strategy Builds Toward 2026 Launch (MedTech Insight)
• Tandem Gears Up For Mobi Tubeless Launch In 2026 After ‘Year Of Transformation’ (MedTech Insight)

• Creatine-filled swag bags and an embrace from Vance: MAHA marks its ascendance in Trump’s Washington (STAT)

• New patent office polices may make it harder for lower-cost medicines to reach consumers (STAT)
• Republicans want to replace enhanced ACA tax credits with direct payments. Their think tank allies aren’t so sure (STAT)
• Testing Trump’s Idea to Replace Obamacare (Bloomberg)
• Judge denies FTC’s bid to block $627M Surmodics buyout (MedTech Dive)