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RSS FeedPosted by Michael Wonder on 22 Jun 2022
BioMarin announces the Ministry of Health, Labor and Welfare in Japan granted approval for Voxzogo (vosoritide) for injection for the treatment of children with achondroplasia, whose growth plates are not closed
21 June 2022 - No lower age restriction for treatment. ...
Posted by Michael Wonder on 07 Jun 2022
Japan drug maker tests medicine vending machine in train station
4 June 2022 - A Japanese pharmaceutical company has started a trial sale of cold medicine, painkillers and other drugs via ...
Posted by Michael Wonder on 16 May 2022
Japan pharma lobbies say pricing scheme leading to renewed 'drug lag'
16 May 2022 - Japan's three major pharmaceutical lobbies joined for the first time on Monday in urging reforms to ...
Posted by Michael Wonder on 19 Apr 2022
Novavax announces approval of Nuvaxovid COVID-19 vaccine for primary and booster immunisation in Japan
19 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adults aged 18 and older in ...
Posted by Michael Wonder on 31 Mar 2022
Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular oedema
28 March 2022 - The bispecific antibody inhibits two disease pathways that drive nAMD and DME by blocking angiopoietin-2 (Ang-2) and ...
Posted by Michael Wonder on 31 Mar 2022
Chugai obtains regulatory approval for Perjeta and Herceptin for additional indication of HER2 positive colorectal cancer
28 March 2022 - Combination therapy of Perjeta and Herceptin obtained regulatory approval for advanced or recurrent HER2 positive colon cancer ...
Posted by Michael Wonder on 31 Mar 2022
Ono receives supplemental approval of Opdivo (nivolumab) for adjuvant treatment of urothelial carcinoma in Japan
28 March 2022 - Ono Pharmaceutical today announced that Ono has received a supplemental approval of Opdivo (nivolumab) in Japan for ...
Posted by Michael Wonder on 29 Mar 2022
Tarlige tablets approved in Japan for treatment of patients with neuropathic pain
28 March 2022 - Daiichi Sankyo today announced that it has obtained approval in Japan to change the indication of ...
Posted by Michael Wonder on 29 Mar 2022
Neurocrine Biosciences announces regulatory approval of Dysval (valbenazine) for the treatment of tardive dyskinesia in Japan
29 March 2022 - Neurocrine Biosciences today announced that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, has obtained regulatory approval of ...
Posted by Michael Wonder on 29 Mar 2022
Ondexxya approved in Japan for reversal of acute major bleeds in patients on factor Xa inhibitors
29 March 2022 - Ondexxya is the first approved reversal agent specifically for factor Xa inhibitors, providing a major advance ...
Posted by Michael Wonder on 28 Mar 2022
Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency
28 March 2022 - Xenpozyme represents first Sanofi therapy to be approved under the SAKIGAKE ‘fast-track’ designation. ...
Posted by Michael Wonder on 28 Mar 2022
Japan's Ministry of Health, Labour and Welfare accepts Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
25 March 2022 - Bristol-Myers Squibb today announced that the MHLW has accepted the supplemental new drug application for Breyanzi ...
Posted by Michael Wonder on 24 Mar 2022
Abbott's FreeStyle Libre is first and only CGM system to gain expanded reimbursement in Japan to include all people with diabetes who use insulin
24 March 2022 - Without expanded coverage, continuous glucose monitoring reimbursements are limited to segment of people with diabetes who require ...
Posted by Michael Wonder on 16 Mar 2022
Submission of oral edarvarone formulation, MT-1186 new drug application in Japan for ALS
14 March 2022 - Mitsubishi Tanabe Pharma announced that the company has submitted to the MHLW in Japan an application ...
Posted by Michael Wonder on 10 Mar 2022
Filing of humanised anti-CD20 monoclonal antibody Gazyva for additional indication of chronic lymphocytic leukaemia
7 March 2022 - Chugai files for regulatory approval following the results from the Phase 3 ELEVATE-TN trial evaluating Gazyva ...