SHANGHAI - China's State FDA has issued new regulations on the reporting and monitoring of adverse events tied to medical devices
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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
A single 15% tariff rate on imports from Europe includes pharmaceuticals, but it remains unclear if the trade deal will exclude generics or if Trump will offer a grace period.
The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.
Comes Days After PDUFA Pushback For GSK's Blenrep.
