Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
BUSINESS
FDA Grants Priority Review to XTANDI for Add’l Indication: Astellas
Astellas Pharma said on May 7 that its prostate cancer agent XTANDI (enzalutamide) has received priority review designation from the US FDA for an additional indication of chemotherapy-naïve metastatic castration-resistant prostate cancer. The Prescription Drug User Fee Act (PDUFA) review…
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Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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,…
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…