TOKYO - Two years ago, Eisai Inc. restructured its R&D operations to create small, venture-like units to be both time- and cost-effective. Now the company is touting the plan's success, having shaved months off of many of its drug development timelines. The company recently filed approval submissions for first-in-class AMPA receptor antagonist perampanel more than a year ahead of schedule
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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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Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.
Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.
