Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Parexel Exec Says FDA Keeps Reviews on Track amid Staff Cuts, but Notes Leadership Drain
The US FDA has largely maintained its drug review timelines and business continuity despite sweeping staff cuts implemented under the Trump administration earlier this year, Paul Bridges, president of consulting at global CRO Parexel, told Jiho in a Tokyo interview.…
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BUSINESS
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The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…