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AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices
FDA reviews safety of approved RSV antibodies for infants
FDA; RSV; nirsevimab; Beyfortus; palivizumab; RSV antibodies; infant safety review; Sanofi; AstraZeneca; Merck; respiratory syncytial virus
Apple Tree files for bankruptcy as it seeks fresh funding from Russian billionaire backer
Apple Tree; bankruptcy filing; insolvency; Russian billionaire backer; restructuring; financing deal; debt obligations; investor rescue
Novartis antibody ianalumab helps prolong control of rare blood disorder ITP
Novartis; ianalumab; primary immune thrombocytopenia; ITP; rare blood disorder; antibody; VAYHIT2 trial; time to treatment failure; disease control; ASH 2025; Promacta; eltrombopag
SanegeneBio raises over $110M Series B after Lilly RNAi deal
SanegeneBio; Series B financing; $110 million; Eli Lilly; RNA interference; RNAi therapeutics; metabolic diseases; Lilly collaboration; clinical-stage assets; liver-targeted RNAi; extrahepatic RNAi; biotech fundraising 2025
Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited
Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy
J&J-backed Cellular Origins raises $40M for cell therapy manufacturing
Cellular Origins; Johnson & Johnson; Series A; $40 million; cell therapy manufacturing; Constellation platform; robotic automation; ATMP; TTP Group; scalable manufacturing
FDA Broadens COVID-19 Vaccine Safety Probe to Adults Under New Health Leadership
FDA; COVID-19 vaccines; safety review; adults; Robert F. Kennedy Jr.; vaccine deaths; public trust; Pfizer; Moderna; myocarditis
UK cuts 2026 new-medicine rebate rate to 14.5% under VPAG
United Kingdom; VPAG; Voluntary Scheme for Branded Medicines Pricing Access and Growth; rebate rate; clawback rate; new medicines; NHS; drug pricing; pharmaceutical industry; 2026
Ansa Biotechnologies Appoints Geoff Hamilton as Chief Financial Officer and Chief Business Officer
Ansa Biotechnologies; Geoff Hamilton; Chief Financial Officer; Chief Business Officer; CFO; CBO; executive appointment; synthetic biology; DNA synthesis; biotech leadership