Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder.
Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder.
As pricing negotiations for Biogen Inc./Eisai Co. Ltd.’s newly approved Leqembi (lecanemab) for Alzheimer’s disease get underway at Japan’s Central Social Insurance Medical Council (Chuikyo), industry watchers see opportunity for potential drug price reform.
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
Japan’s Ministry of Health, Labour and Welfare approved Taiho Pharmaceutical Co. Ltd.’s Lytgobi (futibatinib) for unresectable biliary tract cancer harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions that has progressed after chemotherapy.
Pharma groups are calling on Japan’s Ministry of Health, Labour and Welfare (MHLW) to reconsider its current drug pricing policies that include annual price cuts on innovative drugs.
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.