COMMENTARY

Japan, US, EU Regulators Trod Different Paths to Iressa Approval; Japan’s Capabilities to Be Tested with Sakigake System

September 24, 2015
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

By Reiji Anasako

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Some seven years in the making, Japan’s Ministry of Health, Labor and Welfare (MHLW) finally rolled out a cost-effectiveness assessment…

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

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Jascha Heifetz, widely regarded as one of the greatest violinists of all time, was once stopped, on 57th Street in Manhattan, by a pedestrian asking, “Could you tell me how to get to Carnegie Hall?” Heifetz pondered the question for…