REGULATORY

Japan Approves Keytruda’s 1st Line RCC, Head and Neck Cancer Use, Bavencio’s Label Expansion and More

December 23, 2019
The Ministry of Health, Labor and Welfare (MHLW) approved a batch of new indications on December 20, including first-line use in advanced renal cell carcinoma (RCC) for the immune checkpoint inhibitors Bavencio (avelumab) and Keytruda (pembrolizumab), with the MSD drug…

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REGULATORY

By Takashi Ebisawa

The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…

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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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…