Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Tremfya Meets Primary Endpoint in Japan PIII Study for Palmoplantar Pustulosis: Janssen
Janssen Pharmaceutical’s human anti-IL-23 monoclonal antibody Tremfya (guselkumab) met its primary endpoint in a domestic PIII study for palmoplantar pustulosis by significantly reducing the palmoplantar pustulosis psoriasis area and severity index (ppPASI) score at the end of Week 16 compared…
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…