Pharmas Write Big M&A Checks Again as Patent Urgency Seizes C-Suites

pharma M&A 2025; biotech acquisitions; patent cliff; pharma patent expirations; Novo Nordisk Akero deal; Johnson & Johnson Intra-Cellular acquisition; Merck Verona Pharma deal; Sanofi Blueprint Medicines acquisition; FGF21 MASH deals; 2025 healthcare deals

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

Updated Efficacy Data of Ivonescimab Plus Chemotherapy as First-Line Treatment for TNBC at ESMO IO 2025

ivonescimab; Yidafan; PD-1/VEGF bispecific antibody; triple-negative breast cancer; TNBC; first-line treatment; ESMO IO 2025; Phase II trial; chemotherapy combination; objective response rate; progression-free survival; disease control rate; PD-L1 CPS subgroups; safety profile; Breakthrough Therapy Designation; HARMONi-BC1; AK112-308

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices