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Stryker systems down after cyberattack — restoration under way
Stryker confirmed a global disruption of internal systems following a cyberattack that affected order processing and manufacturing operations. The company indicated it believes the incident is...
FDA broadens GSK RSV shot clearance — wider label granted
The U.S. Food and Drug Administration expanded the approved indication for GSK’s RSV vaccine, granting broader clearance for use in additional adult populations. The decision follows post‑launch...
China approves first commercial brain implant — BCI enters clinic
China’s regulator approved a coin‑sized, wireless brain‑computer interface (BCI) developed by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries....
Orphan drugs to exceed $400B by 2032 — Evaluate projects surge
Evaluate’s 2026 Orphan Drugs Report forecasts global annual orphan drug sales reaching roughly $409 billion by 2032, up from an estimated 15% share of prescription medicines in 2022 to more than...
Cytokine scaffold extends CAR‑T life — durability advances in preclinical models
Researchers at Albert Einstein College of Medicine reported a modular protein scaffold (HCW9206) that links IL‑7, IL‑15 and IL‑21 to generate CAR‑T cells enriched in T memory stem cells,...
AI in biotech: Insilico joins index — models speed lab discovery
Insilico Medicine secured inclusion in the Hang Seng Composite Index, signaling wider investor access to a clinical‑stage AI‑driven biotech and strengthening its market profile. The listing will...
Tumor surface 'flag' and trispecific engager open new immunotherapy routes
UCSF researchers discovered that the oncogene Src can appear on the exterior of tumor cells via autophagolysosomal exocytosis, presenting an extracellular Src (eSrc) antigen that antibody...
Amino acids and new assays boost nanoparticle delivery — delivery bottleneck loosened
A team at Biohub reported that co‑injecting a three‑amino‑acid cocktail with lipid nanoparticles markedly increased in vivo mRNA delivery and CRISPR editing efficiency in preclinical models,...
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...