December 10, 2025

FDA reviews safety of approved RSV antibodies for infants

20 hours ago talkbio0Tagged AstraZeneca, Beyfortus, Infant, Merck, nirsevimab, palivizumab, Respiratory syncytial virus, RSV antibodies, safety review, sanofi, United States Food and Drug Administration

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

20 hours ago talkbio0Tagged backer, Bankruptcy filing, debt obligations, financing characteristics, insolvency, investor rescue, Malus domestica, restructuring, Russian language

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

1 day ago talkbio0Tagged Antibodies, Asymmetric Septal Hypertrophy, Autoimmune thrombocytopenia, disorder control (procedure), eltrombopag, ianalumab, Inosine Triphosphate, ITP, Novartis, Promacta, rare blood disorder, treatment failure, VAYHIT2 trial

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

1 day ago talkbio0Tagged clinical-stage assets, eli lilly, extrahepatic RNAi, Fund Raising, Lilly collaboration, liver-targeted RNAi, Metabolic Diseases, RNA, RNA Interference, SanegeneBio, Series B financing

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

1 day ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

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

1 day ago talkbio0Tagged cell therapy manufacturing, Cellular Origins, Constellation platform, cyclic adenosine-5'-trimetaphosphate, Groups, Johnson & Johnson, Manufacturing, Purpura, Thrombotic Thrombocytopenic, robotic automation

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

1 day ago talkbio0Tagged Adult, COVID19 (disease), Moderna, Myocarditis, Pfizer, public trust, safety review, United States Food and Drug Administration, vaccine deaths, Vaccines

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

1 day ago talkbio0Tagged branded medicines, clawback rate, Drug Industry, drug price, Growth, Nance-Horan syndrome, rebate rate, United Kingdom, valproic acid glucuronide, Voluntary Scheme

United Kingdom; VPAG; Voluntary Scheme for Branded Medicines Pricing Access and Growth; rebate rate; clawback rate; new medicines; NHS; drug pricing; pharmaceutical industry; 2026

PathAI’s AIM-MASH AI Assist Receives Historic FDA Qualification for MASH Clinical Trials

2 days ago talkbio0Tagged AI Assist, AIM-MASH, biomarker qualification, Biopsy of liver (procedure), Clinical Trials, Drug Development Tool, EMA qualification, Histology, MASH, MASLD, metabolic dysfunction-associated steatohepatitis, Nonalcoholic Steatohepatitis, PathAI, Pathology, Qualification, United States Food and Drug Administration

PathAI; AIM-MASH; AI Assist; FDA qualification; Drug Development Tool; biomarker qualification; MASH; MASLD; NASH; metabolic dysfunction-associated steatohepatitis; AI pathology; clinical trials; EMA qualification; liver biopsy; histology

Pluri Appoints Alejandro Weinstein as Chairman of the Board to Lead Strategic Shift and Unlock Value, Backed by Additional Investment

2 days ago talkbio0Tagged Alejandro Weinstein, Biotechnology, Boards (medical device), commercialization, Corporate, governance, Health care facility, Investments, M&A transactions, ownership increase, Pluri, strategic shift, Surgical construction, Zami Aberman

Pluri; Alejandro Weinstein; Chairman of the Board; strategic shift; additional investment; ownership increase; Zami Aberman; Vice Chairman; biotechnology; healthcare; M&A transactions; value creation; commercialization; corporate governance