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FDA expands Arexvy label: GSK wins broader RSV clearance
The U.S. Food and Drug Administration granted broader clearance for GSK’s respiratory syncytial virus vaccine Arexvy, extending the labeled population and potential use cases for the shot. The...
China approves commercial BCI: Neuracle’s brain implant cleared for spinal‑injury use
Chinese regulators approved a coin‑sized, wireless brain‑computer interface (BCI) made by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries—the...
Cadonilimab combo: Phase III COMPASSION‑16 shows first‑line benefit in advanced cervical cancer
The COMPASSION‑16 Phase III trial reported that adding cadonilimab to first‑line chemotherapy—alone or with bevacizumab—improved outcomes in advanced cervical cancer. Trial investigators presented...
KRAS interception halts precancerous pancreatic lesions; senolytics show therapy promise
Two separate lines of pancreatic cancer research reported actionable advances. A University of Pennsylvania–led preclinical study demonstrated that early intervention with KRAS inhibitors can...
CAR‑T durability reengineered: cytokine scaffolds and manufacturing tweaks boost persistence
Academic teams reported manufacturing and molecular strategies that significantly extend CAR‑T cell persistence in preclinical models. Albert Einstein College of Medicine investigators described a...
Amino acid cocktail supercharges LNP delivery: improved in vivo mRNA and CRISPR efficacy
Researchers at the Biohub reported that co‑administering a tailored amino acid supplement dramatically improved lipid‑nanoparticle (LNP) uptake and performance for mRNA delivery and CRISPR editing...
Stryker hit by cyberattack: global internal systems disrupted, operations delayed
Stryker disclosed a cyberattack that disrupted internal Microsoft‑based systems worldwide, knocking out some business applications and delaying order processing and manufacturing activities. The...
Orphan drug boom meets FDA flexibility: $400B sales forecast alongside RDEP trial leeway
Evaluate’s 2026 Orphan Drugs Report projects global orphan drug sales surpassing $400 billion by 2032, driven by expanding portfolios at companies such as Johnson & Johnson and Vertex. The report...
Immutep’s LAG‑3 drug fails Phase III — Stock tumbles
Immutep disclosed that an independent data monitoring committee recommended stopping its Phase III TACTI‑004 trial of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer for futility,...
Cadonilimab combo extends control in advanced cervical cancer — Phase 3 readout
COMPASSION‑16 Phase III data show that adding cadonilimab to first‑line chemotherapy, with or without bevacizumab, improved outcomes in advanced cervical cancer, according to the trial...
Ultragenyx gene therapy hits co‑primary endpoint — Mid‑trial success in urea cycle disorder
Ultragenyx reported that its AAV‑based gene therapy reached one of two co‑primary endpoints in the Phase III study for ornithine transcarbamylase (OTC) deficiency, demonstrating a significant...
FDA draft allows non‑US comparators — Biosimilar testing bar lowered
The U.S. Food and Drug Administration issued draft guidance permitting sponsors to use comparator data from non‑U.S. reference products in certain biosimilar development programs, the agency said....
Triple‑cytokine scaffold boosts CAR‑T durability — Preclinical persistence gains
Researchers at Albert Einstein College of Medicine published preclinical results showing a modular protein scaffold that links IL‑7, IL‑15 and IL‑21 during CAR‑T manufacture generated cells with...
Src flips to cell surface: antibody payloads shrink tumors in mice
UCSF researchers published that the oncogene Src, long considered an intracellular kinase, appears on the extracellular membrane of multiple tumor types via autophagolysosomal exocytosis and can...
OpenAI and Ginkgo: AI designs and runs real biology experiments
OpenAI and Ginkgo Bioworks demonstrated that generative AI integrated with an autonomous laboratory workflow can design, iterate and execute real biology experiments at scale, accelerating...
Lucence leads S$6M multiomic tumor profiling push — UNITED 2.0
Lucence Diagnostics, A*STAR’s DxD Hub and the National Cancer Centre Singapore launched UNITED 2.0, a S$6 million program to develop a clinical whole‑genome and whole‑transcriptome sequencing...
Rare disease drug sales to top $400B by 2032 — Evaluate forecast
Evaluate released its 2026 Orphan Drugs Report projecting global orphan drug sales will exceed $400 billion annually by 2032, up from 15% of prescription drug sales in 2022 to over 21% of the...
Evotec to cut 800 jobs, close four sites — Large restructuring under way
Contract research and development company Evotec announced a restructuring—code‑named Horizons—that will eliminate up to 800 roles (about one‑sixth of its workforce), close four facilities and...
Immutep trial stops for futility — shares crater
Immutep’s phase III TACTI-004 study of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer was halted after an independent data monitoring committee recommended stopping for futility....
Ultragenyx gene therapy clears key phase‑3 endpoint — rare disease win
Ultragenyx reported that its gene therapy candidate met a primary (and in one report, a co‑primary) endpoint in a phase III study for an inherited urea cycle disorder, demonstrating a...