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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...
House passes INVEST Act to widen capital access for small biotech
The U.S. House of Representatives approved the INVEST Act, a bipartisan package designed to free up capital for small innovative firms by removing regulatory barriers and expanding investor...
Lilly’s triple-agonist sets new weight-loss bar – phase 3 data
Eli Lilly reported landmark Phase 3 data showing its triple-agonist retatrutide delivered unprecedented long-term weight loss in people with obesity. Company and industry coverage show high-dose...
Gene‑edited cell transplant restores insulin production – first human case
Scientists reported a first-in-human case in which gene‑edited insulin-producing cells were transplanted into a man with type 1 diabetes and produced endogenous insulin without the need for...
Arcus and Gilead’s TIGIT program collapses – late‑stage trials halted
Arcus Biosciences and partner Gilead reported a Phase 3 failure for their anti‑TIGIT antibody domvanalimab in upper gastrointestinal cancers, prompting an immediate halt to the program and a...
FDA weighing boxed warning for Covid vaccines — experts push back
Multiple outlets reported that FDA officials are considering adding a boxed (boxed/’black‑box’) warning to Covid‑19 vaccine labeling, a move that has drawn immediate criticism from public health...
AC Immune posts biomarker gains in Parkinson’s vaccine – regulator talks next
AC Immune released Phase II biomarker data for its anti‑alpha‑synuclein active immunotherapy showing coherent changes across cerebrospinal and imaging markers (α‑syn, NfL, GFAP, DaT‑SPECT) that...
FDA clears two oral drugs for gonorrhea – new antibiotic options expand
Regulators have approved new oral therapies for uncomplicated gonorrhea, adding zoliflodacin (Nuzolvence) and gepotidacin (Blujepa/GSK) to treatment options for Neisseria gonorrhoeae. Regulatory...
EU clinches sweeping pharma reform deal – legislative overhaul agreed
European institutions reached political agreement on a major package of pharmaceutical reforms — the first comprehensive update in two decades — according to industry reports. The deal covers...
Disco closes €36M seed to advance surfaceome discovery platform
Disco Pharmaceuticals closed a €36 million (≈US$42M) seed financing to accelerate its surfaceome platform toward formal preclinical development, the company said in a funding announcement....
Inotiv taps Vugene AI for multiomics-assisted drug discovery
Contract research organization Inotiv announced a partnership with Vugene to integrate the Lithuanian firm’s multiomics AI platform into early discovery workflows, aiming to improve efficacy and...