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RSS FeedPosted by Michael Wonder on 11 Jun 2021
Delytact oncolytic virus G47∆ approved in Japan for treatment of patients with malignant glioma
10 June 2021 - First oncolytic virus ever approved for treatment of malignant glioma or any primary brain cancer. ...
Posted by Michael Wonder on 31 May 2021
Marketing approval received in Japan for Ninlaro as a maintenance therapy after first-line treatment for multiple myeloma without prior stem cell transplantation
27 May 2021 - Takeda today announced that it has received approval from the Japanese Ministry of Health, Labour and ...
Posted by Michael Wonder on 24 May 2021
Japan issues final approval for Moderna and AstraZeneca vaccines
21 May 2021 - Health minister Norihisa Tamura gave his final approval Friday for emergency use of two more COVID-19 ...
Posted by Michael Wonder on 14 May 2021
Japan’s Ministry of Health, Labour and Welfare grants priority review for enfortumab vedotin new drug application
14 May 2021 - New drug application, submitted in March, is for locally advanced or metastatic urothelial cancer that has ...
Posted by Michael Wonder on 13 May 2021
Daiichi Sankyo submits application for additional indication of mirogabalin in Japan
13 May 2021 - Daiichi Sankyo today announced that it has submitted a supplemental new drug application for mirogabalin besylate ...
Posted by Michael Wonder on 25 Apr 2021
Gilead Sciences submits new drug application in Japan for filgotinib for the treatment of ulcerative colitis with an inadequate response to conventional therapies
23 April 2021 - Application is based on Phase 2b/3 SELECTION trial data with patients with moderately to severely active ulcerative ...
Posted by Michael Wonder on 15 Apr 2021
Orladeyo now reimbursable in Japan via National Health Insurance
15 April 2021 - Japan’s National Health Insurance System has approved the addition of Orladeyo (berotralstat), an oral preventive treatment ...
Posted by Michael Wonder on 25 Mar 2021
Akebia Therapeutics announces approval for additional indication of Riona (ferric citrate hydrate) for the treatment of iron deficiency anaemia in adult patients in Japan
24 March 2021 - Akebia Therapeutics today announced that its collaboration partner, Japan Tobacco received approval from the Pharmaceuticals and ...
Posted by Michael Wonder on 25 Mar 2021
Lamira, an eFlow rechnology nebulizer, expected to launch in Japan as a medical device for exclusive administration of Arikayce (amikacin liposome inhalation suspension)
24 March 2021 - PARI Pharma announces the authorisation of the Lamira nebuliser system for delivery of Insmed's drug product Arikayce ...
Posted by Michael Wonder on 25 Mar 2021
Uplinza (inebilizumab-cdon) approved by Japanese Ministry of Health, Labour and Welfare for the prevention of relapses of neuromyelitis optica spectrum disorder
24 March 2021 - Horizon Therapeutics today announced that its strategic partner Mitsubishi Tanabe Pharma Corporation has received manufacturing and marketing ...
Posted by Michael Wonder on 24 Mar 2021
Chugai obtains approval for Polivy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma
23 March 2021 - Polivy is approved as a first in class anti-CD79b antibody-drug conjugate based on data including the Japanese ...
Posted by Michael Wonder on 24 Mar 2021
Bayer receives approval for Vitrakvi in Japan
23 March 2021 - The Japanese marketing authorization of Vitrakvi follows the approval of the expanded use of FoundationOne CDx, a ...
Posted 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 ...