BEIJING - The leadership of WuXi PharmaTech, China's top contract research organization, has spelled out for the first time in detail how its ill-timed acquisition of an American biologics manufacturing and testing outfit, lashed by the tempests of the West's financial crisis, triggered a massive loss that wiped out five years of earnings
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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.
