Blog
RSS FeedPosted by Michael Wonder on 28 Sep 2022
CSL receives manufacturing and marketing authorisation in Japan for “Berinert SC injection 2000,” as a medicine for prevention of acute hereditary angioedema attacks
26 September 2022 - At home subcutaneous therapy advances treatment options for patients and marks a milestone in 40 years of ...
Posted by Michael Wonder on 27 Sep 2022
Merck’s Keytruda (pembrolizumab) receives four new approvals in Japan, including in high risk early stage triple negative breast cancer
27 September 2022 - Keytruda now approved for 23 uses in 13 different types of cancer in Japan. ...
Posted by Michael Wonder on 27 Sep 2022
Carvykti (ciltacabtagene autoleucel) receives approval from Japan’s MHLW for the treatment of patients with relapsed or refractory multiple myeloma
28 September 2022 - Legend Biotech announced today that Japan’s MHLW has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen ...
Posted by Michael Wonder on 27 Sep 2022
Koselugo approved in Japan for paediatric patients with plexiform neurofibromas in neurofibromatosis type 1
27 September 2022 - First medicine approved in Japan to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 27 Sep 2022
Tezspire approved in Japan for the treatment of severe asthma
27 September 2022 - Tezspire approved for a broad population of patients with severe asthma with no phenotype or biomarker ...
Posted by Michael Wonder on 26 Sep 2022
Fintepla (fenfluramine) approved in Japan for the treatment of seizures associated with Dravet syndrome
26 September 2022 - Nippon Shinyaku announced today that UCB Japan has obtained marketing approval from the Ministry of Health, ...
Posted by Michael Wonder on 26 Sep 2022
Ezharmia approved in Japan as first dual EZH1 and EZH2 inhibitor therapy for patients with adult T-Cell leukaemia/lymphoma
26 September 2022 - Approval based on pivotal Phase 2 trial where Ezharmia demonstrated an objective response rate of 48% ...
Posted by Michael Wonder on 12 Sep 2022
Japan health ministry panel backs Pfizer and Moderna omicron boosters
12 September 2022 - Pfizer and Moderna’s COVID-19 vaccines targeting the omicron variant have won the backing of health experts ...
Posted by Michael Wonder on 06 Sep 2022
Amazon eyes Japan's online prescription drug market
5 September 2022 - E-commerce giant considers creating platform with local pharmacies. ...
Posted by Michael Wonder on 01 Sep 2022
Recell System insurance coverage begins in Japan for treatment of acute burns
1 September 2022 - Reimbursement in Japan will be similar to that of pricing in the United States. ...
Posted by Michael Wonder on 30 Aug 2022
Evusheld long-acting antibody combination approved for prevention and treatment of COVID-19 in Japan
30 August 2022 - First global approval for Evusheld as a COVID-19 treatment. ...
Posted by Michael Wonder on 30 Aug 2022
Quizartinib supplemental new drug application submitted in Japan for patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia
30 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 25 Aug 2022
Myriad Genetics receives expanded coverage in Japan for use of BRACAnalysis Diagnostic System as a companion diagnostic for Lynparza in early-stage breast cancer
25 August 2022 - Myriad Genetics today announced Japan’s MHLW has granted expanded coverage for the use of Myriad’s BRACAnalysis ...
Posted by Michael Wonder on 25 Aug 2022
Ultomiris approved in Japan for the treatment of adults with generalised myasthenia gravis
25 August 2022 - First and only long-acting C5 complement inhibitor offers early onset and sustained efficacy, and has the ...
Posted by Michael Wonder on 25 Aug 2022
Chugai obtains regulatory approval for Polivy for additional indication of previously untreated diffuse large B-cell lymphoma
24 August 2022 - The approval is based on the results from a Phase 3 POLARIX study in patients with ...