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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...
CHMP recommends rejecting Anavex Alzheimer pill: impurities and weak efficacy cited
The European Medicines Agency’s CHMP recommended rejecting Anavex Therapeutics’ Alzheimer candidate following a review that raised concerns over product impurities, safety signals and insufficient...
Gene-edited cell transplant restores insulin—no immunosuppression
Scientists reported the first successful transplantation of gene-edited insulin-producing cells into a man with type 1 diabetes that restored endogenous insulin production without the need for...
Arcus halts domvanalimab Phase 3 after futility; pivots R&D
Arcus Biosciences and partner Gilead announced that an independent data monitoring committee recommended stopping a Phase 3 trial of the anti-TIGIT antibody domvanalimab for futility in upper...
CHMP advances multiple medicines—European approvals move forward
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on multiple new medicines in its December meeting. The committee recommended approval...
FDA weighing boxed warning for Covid vaccines—experts push back
Multiple sources reported the U.S. Food and Drug Administration is contemplating issuing a boxed (black‑box) warning for one or more Covid‑19 vaccines; agency officials have not finalized the...
Human monoclonal antibodies neutralize clade 2.3.4.4b H5N1
Researchers described a new panel of human monoclonal antibodies that potently neutralize clade 2.3.4.4b H5N1 hemagglutinin in vitro and mapped their binding sites at molecular resolution. Led by...