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Immutep’s LAG‑3 gamble collapses: phase III efti trial stopped
Immutep disclosed that an independent data monitoring committee recommended stopping its phase III TACTI‑004 study of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer for futility....
Ultragenyx clears a Phase 3 bar: gene therapy lowers ammonia in urea‑cycle trial
Ultragenyx reported that its gene therapy candidate met a co‑primary endpoint in a Phase 3 study for a urea cycle disorder, showing a statistically significant reduction in blood ammonia levels....
In vivo CAR‑T by injection: nanoparticles generate therapeutic T cells
Johns Hopkins researchers demonstrated biodegradable, targeted mRNA nanoparticles that program patients’ own T cells in vivo to express an anti‑CD19 CAR, causing B‑cell depletion in preclinical...
Bacterial biosynthesis breakthrough cracks doxorubicin bottleneck
An international consortium reported engineering bacterial pathways to overcome a decades‑old production bottleneck for doxorubicin, a core anthracycline chemotherapy. The work, published in...
Eurofins CDMO Alphora scales next‑gen ADC tools and deploys AI salt screening
Eurofins CDMO Alphora announced participation in an international NextGen ADC consortium to develop high‑yield expression vectors and peptide linker tags aimed at simplifying antibody‑drug...
GSK, Oxford and Imperial launch MiMeC: digital twins for drug development
GSK, Imperial College London and the University of Oxford announced the Modelling‑Informed Medicine Centre (MiMeC), an £11 million initiative to build open‑source digital twins of lungs, liver and...
AI drives faster bench science: OpenAI and Ginkgo demonstrate autonomous discovery loop
OpenAI and Ginkgo Bioworks published work showing an AI model coupled to an autonomous lab platform can design, execute and iterate real biology experiments at accelerated speed. The collaboration...
Amino‑acid cocktail boosts LNP performance: simple metabolic tweak improves delivery
Researchers at Biohub reported that co‑administration of a three‑amino‑acid supplement markedly increases lipid‑nanoparticle (LNP) uptake and in vivo mRNA and CRISPR editing efficiency. The team...
FDA draft eases biosimilar pathway: foreign comparators and reduced testing proposed
The US Food and Drug Administration issued draft guidance that could lower the bar for biosimilar development by allowing data from comparator products sourced outside the United States and...
China greenlights first commercial brain implant: Neuracle wins BCI approval
China approved a coin‑sized, wireless brain‑computer interface developed by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries — a global first for...
China biotech milestone: first commercial BCI approved; US cell‑therapy trial cleared
China’s regulator cleared the first brain‑computer interface (BCI) for commercial use while a Shanghai cell‑therapy developer secured US trial authorization, marking consecutive regulatory wins...
GSK expands RSV shot use: FDA grants broader clearance
The U.S. Food and Drug Administration granted broader clearance for GSK’s respiratory syncytial virus (RSV) vaccine, expanding the vaccine’s labeled use and potentially increasing uptake after an...
Immutep’s Phase‑3 miss sinks stock — LAG‑3 candidate stopped for futility
Australian immunotherapy company Immutep halted its global Phase‑3 lung cancer trial after an independent data monitoring committee recommended stopping for futility, a surprise outcome that sent...
Ultragenyx posts Phase‑3 win: gene therapy lowers ammonia in urea‑cycle disorder
Ultragenyx reported that its gene therapy candidate achieved one of two co‑primary endpoints in a Phase‑3 study for ornithine transcarbamylase (OTC) deficiency, a rare urea‑cycle disorder that...
Enodia acquires Kezar Sec61 programs — push into targeted protein degradation
Enodia Therapeutics acquired Kezar Life Sciences’ Sec61 discovery and development assets, including clinical‑stage candidate KZR‑261, under a deal that includes an initial $1 million upfront...
In vivo CAR‑T via nanoparticles: Johns Hopkins demonstrates systemic T‑cell engineering
Johns Hopkins researchers reported a biodegradable, polymer‑based nanoparticle that delivers mRNA encoding an anti‑CD19 chimeric antigen receptor (CAR) directly into T cells in vivo, producing...
Amino‑acid boost supercharges LNP delivery — simple metabolic tweak improves mRNA and CRISPR efficacy
Researchers at Biohub reported that co‑injecting a three‑amino‑acid cocktail with lipid nanoparticles (LNPs) markedly improved in vivo mRNA delivery and CRISPR editing efficiency in preclinical...
Vitestro raises $70M to scale robotic phlebotomy — clinical pilots and FDA path in focus
Netherlands‑based medical robotics company Vitestro closed a $70 million Series B to commercialize its Aletta Autonomous Robotic Phlebotomy Device (ARPD) and expand clinical pilots across Europe...
Vima expands movement disorder program — Series A reaches $100M as Parkinson’s added
Neuroscience startup Vima Therapeutics extended its Series A financing by $40 million, bringing total raised to $100 million to fund clinical development of its muscarinic receptor antagonist...
FDA to unify adverse‑event trackers: single platform for safety surveillance
The FDA announced plans to consolidate multiple adverse‑event reporting systems into a single Adverse Event Monitoring System (AEMS) to centralize safety data for drugs, vaccines and other...