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China clears dual APRIL/BAFF candidate for IgA nephropathy trials
Changchun Genescience Pharmaceutical received NMPA clearance to begin clinical trials of Gensci‑136, a dual APRIL/BAFF antagonist formulated for injection to treat immunoglobulin A nephropathy...
FDA accepts IND for CSPC’s GLP‑1/GIP dual agonist for weight management
CSPC Pharmaceutical Group announced that the FDA cleared an investigational new drug (IND) application for SYH‑2082, a long‑acting GLP‑1/GIP dual‑biased agonist peptide for weight management in...
AI links insulin resistance to risk for 12 cancers in 500K cohort
A University of Tokyo team deployed a machine‑learning predictor called AI‑IR to estimate insulin resistance from nine routine clinical measurements across 500,000 UK Biobank participants and...
NYU Langone forecasts autonomous clinical AI within five years
Leaders in health informatics at NYU Langone told reporters they expect fully autonomous clinical AI—algorithms that operate without human oversight for routine tasks—within roughly five years,...
FDA turmoil: Two senior exits and allegations roil agency
Former FDA oncology chief Richard Pazdur says he resigned after being pressured to endorse a policy that reduces clinical trial requirements, alleging he was handed a prewritten quote and told to...
FDA rejects Disc Medicine drug: surrogate endpoint fails to convince
The FDA issued a complete response to Disc Medicine, finding that the surrogate biomarker reduction used in the company’s submission—percent change in whole-blood metal-free PPIX—was not a...
Genome assembly without ultra-long reads: algorithm narrows the gap
Haoyu Cheng at Yale unveiled hifiasm (ONT), an algorithm that assembles near end-to-end human genomes using standard sequencing inputs, eliminating the need for ultra-long DNA reads that demand...
FDA clears IND for CSPC’s GLP-1/GIP candidate for weight management
CSPC Pharmaceutical Group received FDA investigational new drug (IND) clearance for SYH-2082, a long-acting peptide that acts as a GLP-1/GIP dual-biased agonist for weight management in people...
Fujifilm opens UK mega-CDMO: 19,000 L single-use capacity comes online
Fujifilm Biotechnologies inaugurated its expanded Teesside campus in the UK, launching what the company calls the largest single-use CDMO facility in Britain after a roughly £400 million ($545...
AI hunts antibiotics: peptides mined from ancient genomes and venoms
César de la Fuente’s team at the University of Pennsylvania is training machine-learning models to search genomes for novel antimicrobial peptides, uncovering candidates in archaea, animal venoms,...
Alzheimer’s cell-type gene map: SIGNET reveals causal regulatory hubs
A University of California, Irvine-led team developed SIGNET, a machine-learning framework that infers cell-type-specific gene regulatory networks for Alzheimer’s disease and produced what the...
High-throughput molecular glues uncover leukemia degrader
Researchers reported a systematic ligand-diversification screen that couples rapid chemistry with cell-based functional assays to discover molecular glues that induce targeted protein degradation....
Pan-inflammasome blocker surfaces for hidradenitis suppurativa
Paratus Sciences presented preclinical data for PS-1001, a first-in-class pan-inflammasome inhibitor designed to block release of IL-1β and IL-18, cytokines implicated in autoinflammatory skin...
Engineered cell therapies for autoimmunity: clinical landscape tightens
Nature Biotechnology published a review summarizing recent clinical progress of engineered cellular immunotherapies in autoimmune diseases, highlighting emerging trial data and translational...
Ex‑FDA oncology chief says he was pressured to back trial cuts
Richard Pazdur, the long‑time FDA oncology veteran who stepped down last year, told the Wall Street Journal he was presented with a ready-made quote and asked to "just agree to it" amid agency...
CBER director faces complaints as Moderna flu review stalls
Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, is the subject of internal complaints alleging misconduct while also overruling staff to return a refusal‑to‑file...
FDA rejects Disc’s rare‑disease drug…fast‑track status didn’t help
The FDA issued a complete response letter to Disc Medicine, rejecting bitopertin for erythropoietic protoporphyria (EPP) and questioning the use of percent change in whole‑blood metal‑free PPIX as...
Fujifilm opens UK single‑use CDMO — £400m campus expansion
Fujifilm Biotechnologies inaugurated its expanded Teesside campus in the UK after a roughly £400 million investment, opening what it calls the country's largest single‑use biopharma CDMO facility....
China clears Gensci‑136 trials — dual APRIL/BAFF antagonist enters clinic
Changchun Genescience Pharmaceutical announced NMPA clearance to initiate clinical trials of Gensci‑136, a dual APRIL/BAFF antagonist for immunoglobulin A nephropathy (IgAN). The NMPA clearance...
Researchers map cell‑type gene regulatory networks for Alzheimer’s
A University of California, Irvine team published what they describe as the first cell‑type‑specific gene regulatory network (GRN) map for Alzheimer’s disease, using a machine‑learning framework...