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Carogra, Xenpozyme Among Japan World-First Approvals

 
• By Lisa Takagi and Ian Haydock

The latest batch of new drug approvals in Japan includes several products receiving their first marketing clearances globally, notably a new oral competitor to a blockbuster ulcerative colitis drug and a high-need therapy for the rare disease ASMD.

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Several world-firsts among new Japan approvals • Source: Shutterstock

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorizations for a large group of new drugs that included several world-first clearances for therapies in ulcerative colitis, dermatology and rare diseases.

While the research-based pharma industry continues to call for reforms to Japan’s reimbursement pricing system, the batch of approvals shows that its national drug review and regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), continues to act expeditiously to

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