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Plasma proteomics predicts Crohn’s disease up to 16 years early
Researchers have developed a plasma proteomic signature that identifies individuals who will develop Crohn’s disease as much as 16 years before clinical onset. The study, led by Feng, Chen, Li and...
c-di-GMP adjuvant boosts TLR4 vaccine efficacy against TB
A team led by Kwon has shown that the cyclic-di-GMP (c-di-GMP) adjuvant enhances TLR4-based vaccine responses against Mycobacterium tuberculosis in preclinical models. The study reports amplified...
FDA clears two new antibiotics for gonorrhea — Nuzolvence, Blujepa
U.S. regulators approved two novel antibiotics for gonorrhea: Innoviva’s zoliflodacin (Nuzolvence) and GSK’s gepotidacin (Blujepa). Both agents received priority review and qualified infectious...
EMA’s CHMP backs new drugs from Hansoh and Cytokinetics
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines at its December meeting, including submissions from Hansoh and Cytokinetics....
Human monoclonals neutralize clade 2.3.4.4b H5N1
Scientists described a panel of human monoclonal antibodies that neutralize clade 2.3.4.4b H5N1 hemagglutinin and provide high-resolution molecular characterization of their binding. Published in...
Gene-edited cell transplant restores insulin... patient off immunosuppressants
Scientists reported the first successful transplant of gene-edited insulin-producing cells into a person with type 1 diabetes, restoring endogenous insulin production without long-term...
FDA plans boxed warning for Covid vaccines: sources
Two reports surfaced that FDA leadership is considering adding a boxed (black box) warning to one or more Covid-19 vaccines. According to agency insiders and media coverage, the...
Arcus halts domvanalimab gastric trial — futility stop
Arcus Biosciences announced a voluntary stop to its Phase 3 Star-221 trial of the anti‑TIGIT antibody domvanalimab in combination with anti‑PD‑1 therapy and chemotherapy after an independent data...
CHMP recommends Anktiva; EMA panel backs several new medicines
The European Medicines Agency’s CHMP issued recommendations this week, including support for ImmunityBio’s Anktiva (nogapendekin alfa inbakicept‑pmin) in BCG‑refractory non‑muscle invasive bladder...
Nucleocapsid mutation raises SARS‑CoV‑2 severity: Nature Communications
Researchers published a study in Nature Communications identifying a nucleocapsid (non‑spike) mutation, denoted XEC, that increases SARS‑CoV‑2 pathogenicity in experimental models. The team led by...
Human monoclonal antibodies neutralize H5N1 clade 2.3.4.4b
A team led by Alzua, León and Yellin reported isolation and characterization of human monoclonal antibodies that neutralize clade 2.3.4.4b H5N1 hemagglutinin, according to a Nature Communications...
Targeting ALKBH5 collapses colorectal cancer stemness — Nature Communications
Researchers published evidence in Nature Communications that the m6A RNA demethylase ALKBH5 sustains colorectal cancer stemness and chemotherapy resistance. The study showed genetic or...
AI unlocks drug insights for breast cancer... Nature Communications study
An interdisciplinary team led by Ge, Mo and Wei published a Nature Communications study introducing a biologically informed deep‑learning framework that improves prediction of drug response in...
c‑di‑GMP adjuvant boosts TLR4 vaccine efficacy against tuberculosis
Kwon and colleagues reported preclinical data demonstrating that cyclic di‑GMP (c‑di‑GMP) augments TLR4‑based vaccine responses against Mycobacterium tuberculosis. In animal studies the adjuvant...
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...