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Legal questions surface over FDA’s new expedited drug pathway – sign‑off and oversight in focus
Reporting flagged legal and procedural concerns about the FDA’s new expedited drug program, including uncertainty about who must sign off on approvals and whether standard review steps can be...
Advocates push Congress to preserve NIH FY2026 funding at $48.7B – urgent call to action
Advocacy groups are urging House representatives to support a FY2026 appropriations bill that maintains NIH funding at the Senate‑approved $48.7B and preserves language preventing caps on indirect...
AI‑trained antibody probes let scientists see protein activity inside living cells
Colorado State University researchers used artificial intelligence to design modified antibodies that fluoresce inside living cells, enabling real‑time visualization of intracellular protein...
FDA backs Hemostemix: regulator signals support for basket protocol
Hemostemix received formal support from the U.S. Food and Drug Administration for its basket protocol approach, the company announced. The FDA’s endorsement clears a regulatory hurdle for testing...
Sarepta’s Elevidys sales fall short – shares slide amid gene therapy safety cloud
Sarepta Therapeutics disclosed preliminary Q4 2025 results showing Elevidys net product revenue of $110.4 million, down 17% from Q3 and missing analyst consensus, prompting an immediate share...
TGFβ-induced shape shift: dormant lung cancer cells evade immune attack
Memorial Sloan Kettering researchers reported in Nature Cancer that disseminated lung adenocarcinoma cells use a TGFβ-driven program to enter dormancy and adopt a rounded morphology that reduces...
Enterococcus faecalis weaponizes redox metabolism: EET activation stalls wound healing
An international team led by NTU Singapore and the University of Geneva published in Science Advances that Enterococcus faecalis impairs wound repair by generating reactive oxygen species via...
Fratricide-driven CD7 CAR‑T: unedited cells demonstrate efficacy in T‑cell leukemia
Researchers publishing in the Journal of Translational Medicine described a fratricide-driven approach using unedited CD7 CAR‑T cells to treat T‑cell leukemia. The strategy leverages intrinsic...
Real-time metabolic monitoring: firms deploy sensors to stabilize cell and gene therapy manufacture
Industry practitioners highlighted by PHCNA emphasize that real-time metabolic monitoring is moving from pilot to production in cell and gene therapy (CGT) workflows. Tia Harmon noted technologies...
Two-step genome editing enables full-length humanized mouse models
Researchers reported a two-step genome editing strategy that creates full-length humanized mouse models, overcoming limitations in regulatory sequence divergence between species. The method...
AI-tuned antibodies act as intracellular lights: researchers accelerate in-cell probes
Colorado State University researchers used artificial intelligence to modify antibodies so they function as high-signal probes inside living cells, enabling dynamic readouts of gene-expression...
Tetraspanin immunocapture: high‑depth proteomics of CSF extracellular vesicles
Scientists described a tetraspanin-based immunocapture method that substantially increases proteomic depth for extracellular vesicles (EVs) isolated from cerebrospinal fluid (CSF). The technique...
SpyGlass, Agomab file for IPOs; Novo Nordisk Foundation pledges $850M to scale startups
SpyGlass Pharma and Agomab Therapeutics filed for initial public offerings, signaling continued investor appetite for clinical-stage biotechs following the J.P. Morgan conference. Both companies...
NIH FY2026: urgent push to preserve Senate-approved $48.7B and grant terms
Advocates urged House representatives to back a FY2026 budget that preserves the Senate Appropriations Committee’s NIH funding level of $48.7 billion and maintains Senate language protecting...
Epkinly fails overall survival end point: AbbVie and Genmab report
AbbVie and Genmab disclosed that Epkinly (loncastuximab tesirine) did not extend overall survival in a Phase 3 trial for diffuse large B‑cell lymphoma (DLBCL). The companies reported topline...
Sarepta’s Elevidys sales miss – CEO defends program amid safety questions
Sarepta Therapeutics reported preliminary Q4 product revenue that missed analyst expectations for its AAV gene therapy Elevidys, with Q4 Elevidys revenue down 17% from the prior quarter. CEO...
ImmunityBio CAR‑NK drives complete responses in Waldenström’s – no lymphodepletion
ImmunityBio reported early trial data showing its off‑the‑shelf allogeneic CD19 CAR‑NK therapy, given with rituximab, produced durable complete responses in Waldenström’s macroglobulinemia...
Novo Nordisk Foundation pledges up to $850M to scale European startups
The Novo Nordisk Foundation committed up to $850 million to expand the BioInnovation Institute’s footprint across Europe, aiming to accelerate translational startups and commercialization of...
SpyGlass, Agomab file IPOs after JPM momentum
SpyGlass Pharma and Agomab Therapeutics filed for initial public offerings, aiming to capitalize on investor interest generated during JPM week and recent biotech market momentum. Both companies...
Extracellular TAC degraders go bispecific – new lysosomal and membrane E3 strategies
BioCentury reported innovators are converting extracellular targeted protein degraders (TACs) into bispecific formats that exploit membrane E3 ligases and novel lysosomal internalizing receptors....