Navitor Pharmaceuticals Inc.’s drug discovery efforts are focused on producing compounds that can selectively dampen or bolster mTORC1 activity. Increased activity of mTORC1 has been linked to metabolic, autoimmune, neurodegenerative, and chronic inflammatory diseases.
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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
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After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
