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US R&D Setbacks For Multiple Japanese Firms

Missed Endpoint, CRL

 
• By Lisa Takagi and Ian Haydock

Several Japanese firms are facing R&D challenges and setbacks in the US, in the form of missed Phase III endpoints, trial recruitment difficulties and a Complete Response Letter.

Nippon Shinyaku and Mitsubishi Tanabe both faced R&D setbacks in the US.
Nippon Shinyaku facing multiple US challenges aid looming LOE • Source: Shutterstock

While many many Japanese firms have shifted much of their commercial and R&D focus to the US, several have recently faced development setbacks that could affect their mid-term outlook in this huge market.

Nippon Shinyaku Co., Ltd.’s Duchenne muscular dystrophy (DMD) therapeutic Viltepso (viltolarsen) recently missed its primary efficacy endpoint in preliminary results from a confirmatory Phase III program designed to support...

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