Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Ultragenyx’s Gene Therapy in Line for Orphan Tag in Japan
A Japanese health ministry panel on September 20 agreed to grant orphan designation for Ultragenyx Japan’s gene therapy DTX401 (pariglasgene brecaparvovec) for the treatment of glycogen storage disease type Ia, or GSDIa. According to the company, GSDIa is caused by…
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REGULATORY
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Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…