REGULATORY

Over 50% of Itraconazole ADR Reporting Comes from Pharmacists in October-December: PMDA

April 20, 2021
The number of reports on suspected adverse drug reactions (ADRs) caused by the antifungal itraconazole products have been increasing since the contamination with a sleep-inducer was found in Kobayashi Kako’s product. More than 50% of such cases were reported from…

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REGULATORY

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…