A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
REGULATORY
Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
The Ministry of Health, Labor and Welfare (MHLW) is urging the Japan unit of Novartis AG to compile measures to prevent the recurrence of flawed data submissions and delayed responses to regulatory inquiries after such problems occurred during the review…
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