Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2023
Bayer submits aflibercept 8 mg for marketing authorisation in Japan
1 March 2023 - Submission to the MHLW in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) ...
Posted by Michael Wonder on 28 Feb 2023
Darolutamide receives approval for additional prostate cancer indication in Japan
27 February 2023 - New approval is based on data from the pivotal Phase 3 ARASENS trial. ...
Posted by Michael Wonder on 30 Jan 2023
Lecanemab receives priority review status in Japan
29 January 2023 - Eisai and Biogen announced today that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β ...
Posted by Michael Wonder on 13 Jan 2023
Daiichi Sankyo submits application for marketing approval of mRNA COVID-19 vaccine (DS-5670) in Japan
13 January 2023 - Daiichi Sankyo today announced the submission of an application for marketing approval of DS-5670 to the ...
Posted by Michael Wonder on 03 Jan 2023
Yescarta now approved in Japan for initial treatment of relapsed/refractory large B-cell lymphoma
23 December 2022 - Based on landmark ZUMA-7 study, patients with LBCL treated with Yescarta in second-line achieved four-fold greater improvement ...
Posted by Michael Wonder on 03 Jan 2023
Libtayo (cemiplimab) approved in Japan for advanced or recurrent cervical cancer
23 December 2022 - Regeneron Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted ...
Posted by Michael Wonder on 28 Dec 2022
Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers
28 December 2022 - Approvals based on significant survival benefits in HIMALAYA, POSEIDON and TOPAZ-1 Phase 3 trials. ...
Posted 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 ...