Blog
RSS FeedPosted by Michael Wonder on 28 Dec 2022
Calquence approved in Japan for adults with treatment naïve chronic lymphocytic leukaemia
28 December 2022 - Calquence significantly increased the time patients lived without disease progression or death versus chemoimmunotherapy. ...
Posted by Michael Wonder on 21 Dec 2022
CAR T cell therapy Breyanzi approved as relapsed or refractory large B-cell lymphoma second-line therapy in Japan
20 December 2022 - Bristol-Myers Squibb today announced that it has received approval in Japan for Breyanzi (lisocabtagene maraleucel), a ...
Posted by Michael Wonder on 20 Dec 2022
Ezharmia launched in Japan as first dual EZH1 and EZH2 inhibitor therapy for patients with adult T-cell leukaemia-lymphoma
20 December 2022 - Ezharmia is the fifth innovative oncology medicine to be launched in Japan by Daiichi Sankyo in ...
Posted by Michael Wonder on 13 Dec 2022
Enhertu supplemental new drug application submitted in Japan for patients with HER2 mutant metastatic non-small-cell lung cancer
13 December 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 results where Enhertu demonstrated clinically meaningful tumour responses. ...
Posted by Michael Wonder on 25 Nov 2022
Taiho Pharmaceutical obtains additional indication of "post-operative adjuvant chemotherapy for hormone receptor positive and HER2 negative breast cancer at high risk of recurrence" for oral anti-cancer agent TS-1
24 November 2022 - Based on POTENT study results. ...
Posted by Michael Wonder on 24 Nov 2022
Enhertu approved in Japan for patients with previously treated HER2 positive metastatic breast cancer
24 November 2022 - Approval broadens indication for Enhertu to earlier use in metastatic breast cancer and requirement for confirmatory ...
Posted by Michael Wonder on 02 Nov 2022
Ardelyx collaboration partner, Kyowa Kirin, announces submission of new drug application for tenapanor for hyperphosphataemia in Japan
31 October 2022 - Ardelyx today announced that its collaboration partner in Japan, Kyowa Kirin, has submitted a new drug application ...
Posted by Michael Wonder on 02 Nov 2022
New reimbursement approved by the Japanese Ministry of Health, Labor and Welfare for the Accuray CyberKnife system to treat trigeminal neuralgia, a condition often causing severe facial pain
26 October 2022 - Accuray Incorporated announced today that the Japanese MHLW has approved reimbursement for the CyberKnife system for the ...
Posted 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% ...