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.
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The osteogenesis imperfecta drug stumbled in a second interim analysis.
