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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...
HIV uses sialoglycans to shield infected CD4+ T cells from myeloid attack
A Nature Communications study led by Singh, Islam and Liu identified sialoglycans on the surface of HIV‑infected CD4+ T cells as a mechanism that reduces myeloid‑cell mediated clearance. The team...
AI and physics-based modeling spots Parkinson’s candidate—Gain shows lead
Gain Therapeutics reported a new Parkinson’s disease therapeutic discovered using a hybrid AI and physics‑based modeling approach. Gene Mack presented a compound that allosterically binds and...
Plasma proteomics predicts Crohn’s disease up to 16 years early
Researchers led by Feng and Chen unveiled a plasma proteomic signature that identifies individuals at high risk of developing Crohn’s disease as early as 16 years before clinical onset. The study...
Oncodetect ctDNA flags recurrence risk in triple‑negative breast cancer
Exact Sciences presented sub‑study results from NSABP B‑59 showing its Oncodetect circulating tumor DNA (ctDNA) MRD assay identified triple‑negative breast cancer patients at higher risk of...
Inotiv inks AI multiomics pact with Vugene for discovery
Contract research organization Inotiv announced a partnership with Lithuanian multiomics analytics firm Vugene to integrate AI‑enabled bioinformatics into early drug discovery workflows. Under the...
Gene-edited cell transplant restores insulin production — first patient report
Scientists reported a clinical milestone: gene-edited, insulin-producing cell transplants enabled endogenous insulin production in a man with type 1 diabetes without systemic immunosuppression....
Sialoglycans let HIV-infected T cells dodge myeloid clearance
Researchers published mechanistic evidence that HIV-infected CD4+ T cells exploit sialoglycans on their surface to resist destruction by myeloid immune cells. The Nature Communications study led...
FDA weighing boxed warnings on Covid vaccines — agency debate intensifies
Multiple reports indicate the U.S. Food and Drug Administration is considering adding boxed (black box) warnings to Covid-19 vaccines; agency insiders and outside experts have publicly debated the...
Arcus halts TIGIT program after Phase III futility — R&D pivot underway
Arcus Biosciences and partner Gilead announced a Phase III failure for the anti‑TIGIT antibody domvanalimab in upper gastrointestinal cancers, prompting Arcus to stop related phase III work and...
EMA’s CHMP backs multiple drug recommendations in December meeting
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approvals for several new medicines and vaccines during its December meeting, including submissions from...
FDA clears Medtronic Onyx for subdural hematoma embolization
The FDA granted clearance to Medtronic’s Onyx liquid embolic system for embolization of the middle meningeal artery as an adjunct to surgery in symptomatic subacute or chronic subdural hematoma,...
Oncodetect MRD test stratifies recurrence risk in triple‑negative breast cancer
Exact Sciences presented data showing its Oncodetect minimal residual disease (MRD) assay identified post‑surgical triple‑negative breast cancer patients at significantly higher risk of distant...
Natera and MEDSIR launch MiRaDoR trial using Signatera to tailor adjuvant therapy
Natera announced a collaborative Phase II MiRaDoR trial with MEDSIR and Roche funding to evaluate Signatera ctDNA monitoring in HR+/HER2‑ early breast cancer. The study will enroll up to 60...
Disco closes €36M seed to advance surfaceome target discovery
Disco Pharmaceuticals announced a €36 million (≈US$42 million) final close on a seed round to fund development of its surfaceome discovery platform and push identified targets toward formal...