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…
COMMENTARY
Japan, US, EU Regulators Trod Different Paths to Iressa Approval; Japan’s Capabilities to Be Tested with Sakigake System
In July, the US FDA approved AstraZeneca’s (AZ) lung cancer drug Iressa (gefitinib) for the first-line treatment of EGFR mutation-positive, advanced or metastatic non-small cell lung cancer (NSCLC). Thirteen years have passed since Iressa won the world’s first approval in…
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COMMENTARY
- MOF Autumn Proposals Signal a Shift from Drug Pricing to Cost-Sharing Reform
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As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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…