Blog
RSS FeedPosted by Michael Wonder on 01 Aug 2024
SanBio obtains marketing approval for Akuugo suspension for intracranial implantation (vandefitemcel) as a therapeutic agent for improving chronic motor paralysis from traumatic brain injury
31 July 2024 - SanBio hereby announces that today on 31 July 2024, it obtained conditional and time limited marketing approval ...
Posted by Michael Wonder on 26 Jun 2024
UCB’s epilepsy drug Briviant (brivaracetam) approved in Japan for treatment of focal onset seizures
26 June 2024 - Approval is supported by positive results from a Phase 3 clinical study which evaluated the efficacy ...
Posted by Michael Wonder on 25 Jun 2024
Ezharmia approved in Japan as first dual EZH1 and EZH2 inhibitor therapy for patients with peripheral T-cell lymphoma
24 June 2024 - Approval based on VALENTINE-PTCL01 results showing a clinically meaningful objective response rate of 43.7% in patients ...
Posted by Michael Wonder on 25 Jun 2024
Tagrisso with the addition of chemotherapy approved in Japan as new first-line treatment for patients with EGFR mutated advanced lung cancer
25 June 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 25 Jun 2024
Takeda announces approval of Livtencity (maribavir) in Japan for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies
24 June 2024 - Livtencity is the first and only post-transplant anti-CMV treatment approved in Japan that targets/inhibits UL97 protein kinase. ...
Posted by Michael Wonder on 17 Apr 2024
Fintempla (fenfluramine) oral solution approved in Japan for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
17 April 2024 - – UCB’s Fintempla (fenfluramine) oral solution has been approved by the Japanese Ministry of Health, Labour, ...
Posted by Michael Wonder on 27 Mar 2024
Truqap plus Faslodex approved in Japan for patients with advanced HR positive breast cancer
27 March 2024 - Approval based on CAPItello-291 results which showed Truqap plus Faslodex reduced the risk of disease progression ...
Posted by Michael Wonder on 27 Mar 2024
Beyfortus approved in Japan for the prevention of RSV disease in infants
27 March 2024 - First and only RSV preventive option for broad infant population authorised for use in Japan. ...
Posted by Michael Wonder on 27 Mar 2024
Takeda announces approval of Adzynma intravenous injection 1500 (apadamtase alfa/cinaxadamtase alfa) in Japan for patients with congenital thrombotic thrombocytopenic purpura
26 March 2024 - Adzynma (apadamtase alfa/cinaxadamtase alfa) is the first and only recombinant ADAMTS13 enzyme replacement therapy for people with congenital ...
Posted by Michael Wonder on 26 Mar 2024
Astellas' Vyloy (zolbetuximab) approved in Japan for treatment of gastric cancer
26 March 2024 - MHLW approval makes Vyloy the first and only CLDN18.2-targeted therapy approved in the world. ...
Posted by Michael Wonder on 19 Feb 2024
Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) granted priority review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer
15 February 2024 - Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin ...
Posted by Michael Wonder on 16 Feb 2024
Japan first in the world to approve Dupixent for chronic spontaneous urticaria
16 February 2024 - Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to ...
Posted by Michael Wonder on 15 Feb 2024
Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs
15 February 2024 - To address and maintain the financial sustainability of the national insurance system, the Government rolled out several ...
Posted by Michael Wonder on 08 Feb 2024
Crovalimab approved in China as the first country for the treatment of paroxysmal nocturnal haemoglobinuria
8 February 2024 - Crovalimab, the fifth Chugai originated global drug, approved for the first time in the world. ...
Posted by Michael Wonder on 01 Feb 2024
Eisai submits new drug application for mecobalamin ultra high dose formulation in Japan for the indication of amyotrophic lateral sclerosis
26 January 2024 - Eisai announced today that it has submitted a new drug application for ultra high dose mecobalamin (development ...