Recon: FDA adcomm recommends Eisai-Biogen Leqembi; Novartis inks deal to buy Chinook for $3.5B

• US FDA panel backs approval for Eisai-Biogen Alzheimer's drug Leqembi (Reuters) (Fierce)
• US FDA Sees Leqembi Data As Vindicating Its Approach To Alzheimer’s Drugs (Pink Sheet)  
• COVID shots should target XBB variants in 2023-24 campaign, US FDA staff say (Reuters)
• Bristol Myers’ cell therapy manufacturing site in Massachusetts is good to go, FDA says (Fierce) (Endpoints)
• FDA wants more data from Abeona Therapeutics as it pushes for BLA (Endpoints)
• US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program (Pink Sheet)
• FDA shakes up top leadership around generic drugs (Endpoints)
• Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
• (BioSpace) (Fierce)
• FDA sets December approval decision for first CRISPR therapy, with 94% of patients free of sickle cell crises (Endpoints)
• Top health officials call for more research to support fentanyl test strips (STAT)
• AMA Urged to Do More to Safeguard Adolescent Gender-Affirming Care (MedPage Today)

• COVID-19 Has ‘Permanently Changed’ How The EMA Works (Pink Sheet)
• Furious patients demand action against Sandoz (MedWatch)
• MHRA Explains Interim Plans For Granting UK-Wide Approvals Until 2025 (Pink Sheet)
• China Proposes Tighter MAH Manufacturing Rules (Pink Sheet)
• AMR Alliance Follows Up Global Industry Standard With Responsible Manufacturing Certification (Pink Sheet)
• Canadian HTA Ups Industry Fees To Fund Review Process Improvements (Pink Sheet)
• EU grants million-euro funding to Danish-Swedish fertility research (MedWatch)

• Novartis buys Chinook for $3.5 bln in race to treat rare kidney disease (Reuters) (STAT)
• Novo Nordisk to invest $2.3B for API production, but not for semaglutide (Fierce) (Endpoints) (Reuters)
• Eisai cyber attack leads to investigation of potential data leaks amid growing industry threat (Endpoints)
• AstraZeneca fleshes out pivotal data on $930M rare blood disorder drug it wants to pair with Soliris, Ultomiris (Endpoints)
• Kura Oncology highlights leukemia remission data as it enrolls larger trial (STAT)
• Patients attack-free a year after receiving Intellia’s hereditary angioderma CRISPR med (Fierce)

• MedTech Forum 2023: Why The Commission Must Not ‘Shoot For The Moon’ With EHDS Plans (MedTech Insight)
• EPA’s proposed ethylene oxide regulations may cost sterilizers more than estimated: Moody’s (MedTech Dive)
• DTA Standardizes Definition Of Digital Therapeutics (MedTech Insight)
• Getinge’s packaging problems continue with recall of circulatory support devices (MedTech Dive)
• Foundation Medicine’s latest companion diagnostic nod pairs its blood test with Pfizer’s Braftovi combo (Fierce)
• Huma nabs FDA nod for AI-backed disease management platform (Fierce)
• SunMed soaks up Avanos’ respiratory health business for $110M (Fierce) (MedTech Dive)
• Illumina CEO deSouza resigns after proxy battle with Icahn (Reuters) (BioSpace)
• Francis deSouza’s tenure at Illumina is a lesson in how not to handle CEO succession (STAT)

• Drug companies and pharmacies reach $17.3 billion settlement over opioid crisis (STAT) (Washington Post)
• BioNTech faces first German lawsuit over alleged COVID vaccine side effects (Reuters)
• US judge rejects 3M effort to resolve earplug lawsuits in bankruptcy (Reuters)
• Johnson & Johnson inks another Stelara patent settlement, this time with Alvotech and Teva (Fierce)
• Boston Scientific Wins $158 Million From Cook in Patents Trial (Bloomberg)
• DOJ Probing Covid Test Fraud Including Kits Sent to Dead People (Bloomberg)
• US Chamber of Commerce sues over government's drug pricing power (Reuters) (STAT)