REGULATORY

Blue Letter on Xeplion Issued Following 21 Reported Deaths; Causal Relationship Remains Unclear

April 18, 2014
The Safety Division of the Ministry of Health, Labor and Welfare’s Pharmaceutical and Food Safety Bureau (PFSB) ordered Janssen Pharmaceutical on April 17 to distribute a flash safety report (blue letter) to medical institutions to warn them against overdosing and…

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REGULATORY

By Ken Yoshino

Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…

By Takashi Ebisawa

Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…

By Philip Carrigan

Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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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…