Blog
RSS FeedPosted by Michael Wonder on 11 Mar 2021
Achievements and challenges of the Sakigake designation system in Japan
10 March 2021 - The Sakigake designation system (the Sakigake) has been launched to encourage the pioneered development of innovative new ...
Posted by Michael Wonder on 11 Mar 2021
Astellas submits new drug application for enfortumab vedotin in Japan
11 March 2021 - Enfortumab vedotin to be reviewed by Ministry of Health, Labour and Welfare for patients with locally ...
Posted by Michael Wonder on 09 Mar 2021
Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan
6 March 2021 - The objective of the study was to clarify the rationales of delay or difference in the ...
Posted by Michael Wonder on 15 Feb 2021
Japan approves Pfizer's COVID-19 vaccine
14 February 2021 - Japan formally approved Pfizer Inc's coronavirus vaccine on Sunday, the first greenlit for domestic use, clearing ...
Posted by Michael Wonder on 25 Jan 2021
Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia
25 January 2021 - 88% of patients on Calquence remained free of disease progression after 12 months vs. 68% for ...
Posted by Michael Wonder on 24 Jan 2021
BioCryst announces approval of Orladeyo (berotralstat) in Japan for the prophylactic treatment of hereditary angioedema
22 January 2021 - BioCryst Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare in Japan has granted ...
Posted by Michael Wonder on 22 Jan 2021
Yescarta approved in Japan for treatment of patients with relapsed/refractory large B-cell lymphomas
22 January 2021 - Approval based on phase 2 study conducted in Japan and previous pivotal trial data. ...
Posted by Michael Wonder on 11 Jan 2021
Myriad Genetics receives first reimbursement decision for myChoice diagnostic system in Japan, enabling women with ovarian cancer to benefit from treatment with Zejula
8 January 2021 - Myriad Genetics announced today that it received its first reimbursement decision for the Myriad myChoice Diagnostic System, ...
Posted by Michael Wonder on 05 Jan 2021
Daiichi Sankyo submits application for oncolytic virus teserpaturev (G47∆) for treatment of patients with malignant glioma in Japan
5 January 2020 - Daiichi Sankyo and the University of Tokyo are collaboratively developing teserpaturev, which has received SAKIGAKE designation and ...
Posted by Michael Wonder on 28 Dec 2020
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
28 December 2020 - Approvals based on the PAOLA-1, PROfound and POLO Phase III trials ...
Posted by Michael Wonder on 17 Dec 2020
Japan to lower drug prices to reduce medical costs
17 December 2020 - Japanese Finance Minister Taro Aso and health minister Norihisa Tamura agreed Thursday to reduce state-set prices ...
Posted by Michael Wonder on 30 Nov 2020
Astellas receives approval of Evrenzo (roxadustat) in Japan for the treatment of anaemia of chronic kidney disease in adult patients not on dialysis
27 November 2020 - Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with ...
Posted by Michael Wonder on 30 Nov 2020
Forxiga approved in Japan for chronic heart failure
30 November 2020 - Forxiga is the first SGLT2 inhibitor approved in Japan for chronic heart failure with reduced ejection ...
Posted by Michael Wonder on 19 Nov 2020
Brickell Biotech announces launch date for sofpironium bromide 5% gel (Ecclock) in Japan by its development partner, Kaken Pharmaceutical
18 November 2020 - Kaken plans to launch Ecclock for the treatment of primary axillary hyperhidrosis in Japan on 26 November ...
Posted by Michael Wonder on 19 Nov 2020
Kyowa Kirin announces approval for partial change of rituximab biosimilar received by Sandoz in Japan
18 November 2020 - Kyowa Kirin today announced that Sandoz KK, its strategic partner of the anti-CD20 monoclonal antibody rituximab ...