REGULATORY

Eisai’s EZH2 Inhibitor, 3 More New Drugs Clear Key Panel, June OK Likely

May 31, 2021
A key health ministry advisory panel gave the blessing to a batch of new medicines including Eisai’s EZH2 inhibitor tazemetostat on May 28, setting the stage for official approval as early as next month. Tazemetostat, which earned US approval in…

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REGULATORY

By Yoshinori Sagehashi

The government is in the process of finalizing the 2021 Basic Policy for Economic and Fiscal Management and Reform (honebuto). This year’s policy will have a higher importance than previous ones because the drastic reforms of the drug pricing system…

By Eric Persoff

Last month, when discussing how life science manufacturers should react to the evolving pricing environment in Japan, I wrote about how manufacturers should align with stakeholders in government and the medical community on fair compensation for innovative, value creating, biopharmaceutical…

The average ratio of female employees at managerial posts stood at just 12.5% at pharmaceutical companies operating in Japan, a Jiho survey revealed. While foreign drug makers had an average 25.0%, the ratio came to as low as 9.8% for…

By Yoshinori Sagehashi

Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…

Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…

Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…