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Concordia expands biomanufacturing — $5M CFI upgrade for green biofoundry
Concordia University announced a CFI‑backed $5 million upgrade to its Genome Foundry and bioprocessing facilities to expand sustainable biomanufacturing capacity. The investment, matched by...
Gene-edited cell transplant restores insulin production — type 1 patient off immunosuppression
Researchers implanted gene-edited insulin-producing cells into a man with type 1 diabetes and documented restoration of endogenous insulin production without systemic immunosuppression. The...
Arcus stops domvanalimab program after Phase III futility — pivots to casdatifan
Arcus Biosciences and partner Gilead halted a Phase III trial of anti‑TIGIT antibody domvanalimab after an independent data monitoring committee flagged futility in first‑line gastric and...
FDA clears two new oral antibiotics for gonorrhea — additional treatment options available
The U.S. FDA approved two oral therapies for gonorrhea—Innoviva’s zoliflodacin (Nuzolvence) and GSK’s gepotidacin (Blujepa)—broadening antibiotic options against a pathogen with rising resistance....
FDA approves new formulation of trofinetide for Rett syndrome — DAYBUE STIX gains clearance
Acadia Pharmaceuticals received FDA approval for DAYBUE STIX, a powder formulation of trofinetide for oral solution for Rett syndrome in patients two years and older. The decision expands...
Plasma proteomics predict Crohn’s disease up to 16 years before diagnosis
A proteomic profiling study identified plasma protein signatures that forecast Crohn’s disease onset as much as 16 years before clinical diagnosis. Researchers profiled longitudinal cohorts and...
Oncodetect MRD shows prognostic signal in triple‑negative breast cancer — Exact Sciences presents first data
Exact Sciences presented initial data from the NSABP B‑59 sub‑study showing its Oncodetect circulating tumor DNA (ctDNA) MRD test identified triple‑negative breast cancer patients at higher risk...
Inotiv partners with Vugene to deploy AI multi‑omics for drug discovery
Contract research organization Inotiv announced a partnership with Lithuanian multi‑omics analytics firm Vugene to integrate AI‑driven bioinformatics into early‑stage discovery workflows. The...
Mechanism for vaccine‑associated myocarditis outlined — CXCL10 and IFN‑γ implicated
Scientists reported mechanistic data linking rare vaccine‑associated cardiomyositis to immune cell activity driven by elevated chemokines CXCL10 and interferon‑γ (IFN‑γ). The paper, published in...
c‑di‑GMP adjuvant enhances TLR4 vaccine efficacy against tuberculosis
Preclinical work showed cyclic‑di‑GMP (c‑di‑GMP) potentiates TLR4‑based vaccine responses against Mycobacterium tuberculosis, improving immunogenicity in animal models. The study demonstrated...
EMA’s CHMP backs multiple new medicines including Hansoh and Cytokinetics submissions
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued recommendations supporting approval for several new drugs and vaccines, including filings from Jiangsu...
Gene-edited islet transplant restores insulin production: first patient shows function
Scientists reported a gene-edited cell transplant that restored insulin production in a patient with type 1 diabetes. The transplanted insulin-producing cells were engineered to evade immune...
FDA weighs boxed warning for Covid vaccines: experts raise alarms
Multiple sources say the U.S. Food and Drug Administration is considering adding a boxed (black-box) warning to Covid-19 vaccines, a regulatory move reported to be under internal discussion at the...
Arcus halts domvanalimab gastric phase III after futility call — pivots to casdatifan
Arcus Biosciences and partner Gilead announced termination of phase III development for their anti‑TIGIT antibody domvanalimab in first-line gastric and esophageal cancer after an independent data...
EMA’s CHMP moves forward: multiple committee recommendations reshape EU approvals
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a block of recommendations this month, endorsing several new marketing authorisations and reaffirming...
FDA clears two new gonorrhea antibiotics — more options for resistant disease
The U.S. Food and Drug Administration approved two new oral antibiotics for gonorrhea: Nuzolvence (zoliflodacin) from Innoviva and Blujepa (gepotidacin) from GSK. Both drugs received expedited...
AI and ctDNA converge in breast cancer: models refine drug insights; MRD predicts recurrence
Researchers published a biologically informed deep‑learning framework that improves prediction of drug response in breast cancer by integrating molecular features with drug representations. The...
Surfaceome startup raises €36M — CROs and AI firms strike discovery deals
Disco Pharmaceuticals closed a €36 million seed round to advance targets discovered with its surfaceome platform, the company said. The funding will support formal preclinical development of...
FDA approves DAYBUE STIX for Rett syndrome — new powder trofinetide formulation
The FDA approved DAYBUE STIX, a powder formulation of trofinetide, for the treatment of Rett syndrome in adults and pediatric patients two years and older. Acadia Pharmaceuticals said the...
Human monoclonal antibodies neutralize clade 2.3.4.4b H5N1 — preclinical advance
Researchers described new human monoclonal antibodies that bind and neutralize hemagglutinin from clade 2.3.4.4b H5N1 avian influenza. The study mapped antibody binding sites and demonstrated...