The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
BUSINESS
Lecanemab Accepted for US Review, Action Date Set for January: Eisai/Biogen
The US FDA has accepted for priority review Eisai’s application for its Alzheimer’s drug lecanemab under its accelerated pathway, the company and US partner Biogen said. An action date under the Prescription Drug User Fee Act (PDUFA) was set for…
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