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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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