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Home » Topics » Regulatory » MHLW

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3D illustration of heart cross section

Bridgebio seeks Japan approval of acoramidis for rare heart disease

Feb. 5, 2024
By Marian (YoonJee) Chu
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.
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3D illustration of heart cross section

Bridgebio seeks Japan approval of acoramidis for rare heart disease

Feb. 5, 2024
By Marian (YoonJee) Chu
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.
Read More
Leqembi

Could Eisai’s Leqembi approval be the trigger for drug price reform in Japan?

Oct. 3, 2023
By Tamra Sami
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.
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Japan’s MHLW approves slew of new drugs, including Eisai/Biogen’s Leqembi for Alzheimer’s

Sep. 26, 2023
By Tamra Sami
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.
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Illustration of cancer in the bile ducts

Japan’s MHLW gives nod to Taiho’s FGFR inhibitor Lytgobi for biliary tract cancer

June 27, 2023
By Tamra Sami
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.
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Japanese money and medicine

Pharma groups urge Japan’s MHLW to reform pricing policies

April 18, 2023
By Tamra Sami
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.
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Japan gears up for another round of drug price revisions but stakeholders push back

Jan. 3, 2023
By Tamra Sami
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.
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Japan gears up for another round of drug price revisions but stakeholders push back

Dec. 29, 2022
By Tamra Sami
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.
Read More
Red wooden approved stamp

Shionogi scores emergency approval for Japan’s first domestic COVID-19 oral antiviral

Dec. 13, 2022
By Tamra Sami
Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral.
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Japan’s MHLW approves raft of new drugs

Oct. 4, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare (MHLW) approved a slew of new drugs in the last week of September, including Japan’s first sustained release GIP/GLP-1 receptor agonist for type 2 diabetes from Eli Lilly and Co. and Mitsubishi Tanabe Pharma Corp.; a self-administered injectable drug for rheumatoid arthritis from Eisai Co. Ltd. and Nippon Medac Co. Ltd.; a CAR T from Legend Biotech Corp. and Janssen Pharmaceutical KK; and two drugs from Astrazeneca plc, one in asthma and the other in pediatric plexiform neurofibromas in neurofibromatosis type 1.
Read More
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