Only 10% of compounds that enter Phase I trials survive to FDA approval, and that has a lot to do with the inadequacy of early-stage research in cell lines. They are poor predictors of what will happen in animal models, much less in patients. The problem stems in part from the fact that cells, once removed from an organism and maintained artificially in a laboratory environment, change their behavior and phenotype in equally artificial ways, which in turn warp their response to drug candidates. HemoShear LLC's technology simulates a cell's natural environment by introducing hemodynamic blood flow and the accompanying shear stresses. Its first system focuses on blood vessels.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
CEO Bill Anderson tells Scrip that the German group looks at potential in-licensing opportunities across every stage of the pipeline “but as you know, good value is a lot harder to come by in the late stage.”
Byterna, Starna, Vivacta and DeliNova ride surging investor sentiment on in vivo CAR-T assets to secure venture funding.
Sagimet may shift focus to later-stage MASH while it lines up Phase III financing. Altimmune expects its dual agonist to show efficacy and tolerability, while GSK is readying efimosfermin as the third FGF21 analog into Phase III for MASH.
