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Nippon Shinyaku Eyes Conditional Early OK for Sakigake DMD Drug, Daiichi Sankyo Redoing PI/II for Its Antisense
(Sep.12.2018)

Nippon Shinyaku is aiming to file its Duchenne muscular dystrophy (DMD) treatment NS-065 under Japan’s newly introduced conditional early approval system in FY2018, informed sources told Jiho. Already designated for the sakigake review pathway, it could become the first product that will tap the two fast-track schemes to reach the market. Meanwhile, Daiichi Sankyo is redoing its PI/II study for DS-5141, another sakigake drug for DMD, after lukewarm initial results ...
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