BUSINESS

Takeda’s Mobocertinib Gets FDA’s Priority Review for EGFR Exon 20-Mutant NSCLC

April 30, 2021
Takeda Pharmaceutical said on April 28 that its application for mobocertinib (TAK-788) has earned the US FDA’s priority review for the treatment of adult patients with EGFR exon 20 insertion mutation-positive metastatic non-small cell lung cancer (NSCLC), with a target…

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BUSINESS

Takeda Pharmaceutical, Eisai, and Nippon Chemiphar offeredearly retirement programs over the past year, a Jiho survey revealed. It appears that not all of them are looking at downsizing, however, with some aggressively seeking to “rejuvenate” their employees by replacing ones…

By Takashi Ohama

The Ministry of Health, Labor and Welfare (MHLW) appears to be ready to begin post-launch drug price adjustments based on cost-effectiveness assessments (CEAs) for the first time since the system was introduced in April 2019. As price tweaks will be…

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…

By Eric Persoff

The past month has seen two significant milestones in healthcare price control measures in Japan: The first “off-year” NHI reimbursement price cuts, and release of the first results under Japan’s “cost-effectiveness assessment” system. Both milestones have been anticipated for quite…