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NeuMap atlas charts neutrophil diversity — a million‑cell single‑cell roadmap
An international consortium released NeuMap, a single‑cell transcriptional atlas of neutrophils analyzing more than one million cells across 47 conditions and multiple tissues, published in...
Terray hits BMS milestone — AI platform finds drugs in unseen chemical space
Terray Therapeutics announced it reached its first discovery milestone under a multi‑target collaboration with Bristol Myers Squibb, validating its Experimentation Meets Machine Intelligence...
Deramiocel Phase 3 win... Capricor shares surge
Capricor reported positive topline results from the pivotal Phase 3 HOPE-3 trial of deramiocel in Duchenne muscular dystrophy (DMD), hitting both its primary muscle endpoint and a key cardiac...
FDA names Høeg to CDER: leadership churn continues
The FDA appointed Tracey Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER), continuing rapid turnover at the agency’s senior ranks. Høeg, who served as a special...
Vaccine rules under fire: ex‑FDA chiefs denounce Prasad
Tensions over vaccine policy intensified as Vinay Prasad, the FDA’s top vaccines regulator, defended proposed changes while a group of former FDA commissioners publicly criticized his plans....
CTAD reveal: semaglutide fails to slow Alzheimer’s decline
Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) 2025 meeting confirmed that oral semaglutide did not slow cognitive decline in the Evoke and Evoke+ phase III trials, reversing...
Pharvaris pill meets Phase 3 goals — FDA filing planned
Pharvaris reported that deucrictibant, an oral bradykinin B2 receptor antagonist for hereditary angioedema (HAE), met primary and secondary endpoints in a Phase 3 on‑demand study and plans to file...
Triana raises $120M — molecular glues head to clinic
Triana Biomedicines closed a $120 million Series B to advance its molecular glue degrader platform and push lead candidate TRI‑611 toward clinical proof‑of‑concept for ALK‑driven non‑small cell...
Terray clears BMS milestone — AI discovery scales binding data
Terray Therapeutics announced it has achieved a discovery milestone under its multi‑target collaboration with Bristol Myers Squibb, validating its Experimentation Meets Machine Intelligence (EMMI)...
Illumina pivots to data products: pharma and AI focus
Illumina is expanding beyond sequencing reagents into data offerings for pharmaceutical partners, launching a BioInsight unit to shoulder sequencing‑intensive projects and retain ownership of...
FDA floats fee incentives — higher charges for offshore Phase 1s
The FDA proposed restructuring user fees to incentivize companies to run early‑stage clinical trials in the U.S., floating lower fees for domestic early‑stage work and higher fees for sponsors...
Venture winter: early‑stage funding collapses for US cell & gene
Venture investment into U.S. seed and Series A cell and gene therapy startups has fallen sharply, according to BioCentury reporting, as investors retreat from high‑risk, capital‑intensive...
Capricor’s DMD cell therapy hits phase III marks — shares explode
Capricor Therapeutics reported positive topline results from its pivotal Phase 3 HOPE-3 trial of deramiocel, meeting the trial’s primary motor endpoint and a key cardiac secondary endpoint. The...
FDA names Tracey Beth Høeg to run CDER — rapid leadership shakeup
The U.S. Food and Drug Administration appointed Tracey Beth Høeg as acting director of its Center for Drug Evaluation and Research (CDER). Høeg, a physician-scientist who served as a special...
Former FDA chiefs and Prasad clash over vaccine rules — NEJM rebuke, defense follows
Twelve former FDA commissioners published a critique in the New England Journal of Medicine opposing proposed changes to vaccine regulation advanced by Vinay Prasad, director of CBER. The...
Triana raises $120M to push molecular glue degrader toward clinic
Triana Biomedicines closed a $120 million Series B to advance its molecular glue degrader program into the clinic, with backing from Pfizer Ventures and other investors. The funding is earmarked...
Genomics data and AI drive new pharma offerings — Illumina, Terray move up
Illumina launched plans for BioInsight, a data‑focused business unit that will produce and monetize sequencing‑intensive datasets for pharma customers, positioning the company to sell data and...
FDA signals regulatory shifts: one‑trial default and user‑fee incentives
FDA Commissioner Marty Makary told STAT the agency plans to make one pivotal clinical trial the default for approvals in many cases, departing from the historical two‑trial expectation. Makary...
NeuMap atlas charts neutrophil diversity — million‑cell resource released
An international consortium led by CNIC, Universidad Carlos III de Madrid, Yale and Westlake University published NeuMap, a neutrophil atlas in Nature that integrates single‑cell transcriptional...
Spatial Touchstone issues standards for spatial transcriptomics — benchmark dataset
A cross‑institution Spatial Touchstone project published in Nature Biotechnology released best practices, SOPs and an open‑source benchmarking portal for imaging‑based spatial transcriptomics....