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
Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.
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First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.
