Heparin Investigation Highlights Foreign Inspection Gap – Former FDA Officials
Members of Congress have jumped on the reported admission by U.S. FDA that it did not inspect a Changzhou City, China plant that provides active pharmaceutical ingredients for Baxter Healthcare's injectable heparin as a symbol of FDA's inability to adequately inspect pharmaceuticals manufactured abroad
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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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Deal snapshot: The Flagship portfolio firm will use its Decode platform to seek novel targets for an unspecified autoimmune disease, with Genentech holding license rights.
Two Phase III trials testing tegoprazan read out positively, but the potassium-competitive acid blocker will compete with Phathom’s Voquezna (vonoprazan).
The Swiss biotech firm could go public on the NASDAQ later this year, and points to other preclinical dealmaking in the space to back its strategy.