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Regulatory action on late-stage assets
European regulators moved to pull Amgen’s vasculitis drug Tavneos from the market after the European Commission canceled its marketing authorization. The recall orders all batches of Tavneos...
US FDA clearance for Alzheimer’s blood testing
The FDA cleared PrecivityAD2, a blood test designed to help evaluate Alzheimer’s disease by detecting amyloid pathology. Developed and validated from technology pioneered at Washington University...
China NMPA advances first-in-class immuno-oncology strategy
China’s NMPA accepted the NDA for opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for previously treated advanced extrapulmonary neuroendocrine carcinoma. The CDE granted priority...
Phase 2/early clinical readouts in solid tumors
NeoZanHER phase 2 data in early-stage HER2-positive breast cancer continue to validate zanidatamab as a next-generation approach for pre-surgical treatment. The Nature Communications-published...
New clinical evidence on GLP-1s and infection risk
A Nature Communications study examined whether GLP-1 receptor agonists affect tuberculosis risk in people with type 2 diabetes. The analysis focused on the intersection of commonly prescribed...
AI and deep-learning tools move toward oncology decision support
Researchers used a deep-learning pathology model to predict nivolumab outcomes in gastric cancer, building toward pathology-derived risk stratification before immunotherapy begins. The work,...
Drug development finance: Amylyx funds ahead of filing
Amylyx moved closer to a potential filing milestone by banking $500 million ahead of submission, according to a finance report. The update positions the company to fund late-stage and...
Clinical development momentum via NMPA clearances in solid tumors and retina
China’s NMPA cleared Akeso’s AK-157D1 to begin a phase I study in advanced solid tumors, allowing the program to enter first-patient dosing. In a separate retina-focused update, Shanghai Matwings...
Biotech business operations: AI platform expansion at EVERSANA
EVERSANA expanded its AI-powered commercialization platform, adding medical affairs and commercial capabilities. The update includes agentic AI orchestration plus workflow automation for content...
Preclinical mechanistic research in cancer immunology and targeted protein control
A Stanford Medicine-led study described TCIP3, a two-headed experimental molecule that eliminated aggressive human lymphoma tumors in mice by converting a cancer growth driver into a built-in kill...
Regulatory action and recall in Europe
European regulators have ordered a recall of all batches of Amgen’s Tavneos (avacopan) after the European Commission canceled the drug’s marketing authorization for the vasculitis treatment...
China NMPA review moves immunotherapy target forward
China’s NMPA accepted the NDA for opamtistomig (LBL-024), a PD-L1/4-1BB–directed bispecific antibody, for patients with previously treated advanced extrapulmonary neuroendocrine carcinoma...
US FDA clears a blood test for Alzheimer’s evaluation
The FDA cleared PrecivityAD2, a blood test intended to help evaluate Alzheimer’s disease by detecting amyloid pathology. Developed and validated through technology pioneered at Washington...
High-impact trial and pipeline finance signals
Silence Therapeutics reported positive Phase II results for divesiran, an siRNA targeting TMPRSS6 in polycythemia vera (PV). In the SANRECO trial (NCT05499013), the company said the study met its...
Stem-cell platform funding for Type 1 diabetes research
Breakthrough T1D awarded Greenstone Biosciences a $1.2 million, three-year Industry Discovery and Development Partnership grant to study biologic variations across type 1 diabetes patients. The...
Cancer biology: precision immune-organoid modeling
A new study in the British Journal of Cancer reports an organoid system designed to recapitulate basal-classical diversity in pancreatic cancer using a dual-oxygen approach. The work uses organoid...
Immunotherapy prediction using deep-learning pathology
Researchers in the British Journal of Cancer described a deep-learning-derived risk score intended to predict outcomes for patients treated with nivolumab in gastric cancer. Using...
Oncology drug development: novel targeting strategy in breast cancer
Australian researchers reported a molecular vulnerability that may help explain the spread of triple-negative breast cancer, and they described how an existing drug could potentially be repurposed...
Biotech AI tooling: commercialization and toxicology atlas launch
DeepCyte launched DeeTox Atlas, a single-cell metabolomic reference atlas intended to map drug toxicity mechanisms. The company said the foundation dataset combines perturbation studies spanning...
Med-tech and care delivery innovation in breast cancer
A study in JAMA Network Open evaluated a telemedicine-supported home injection model for breast cancer patients receiving injectable gonadotropin-releasing hormone agonist therapy. The research...