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RSS FeedPosted 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 ...
Posted by Michael Wonder on 06 Mar 2022
Eisai initiates submission of application data under the prior assessment consultation system in Japan with the aim of obtaining early approval for investigational anti-amyloid beta protofibril antibody lecanemab
4 March 2022 - Eisai and Biogen announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices ...
Posted by Michael Wonder on 02 Mar 2022
Shionogi files for approval of S-217622, a therapeutic drug for COVID-19, in Japan
25 February 2022 - Shionogi today announced that Shionogi has completed the analysis of primary endpoints a), b) in the Phase ...
Posted by Michael Wonder on 02 Mar 2022
Lenvima (lenvatinib) plus Keytruda (pembrolizumab) approved in Japan for radically unresectable or metastatic renal cell carcinoma
25 February 2022 - Results from CLEAR/KEYNOTE-581 showed Lenvima plus Keytruda significantly reduced the risk of disease progression or death by ...
Posted by Michael Wonder on 25 Jan 2022
Bimzelx (bimekizumab) approved in Japan for the Treatment of plaque psoriasis, generalised pustular psoriasis and psoriatic erythroderma
24 January 2022 - The third approval for bimekizumab worldwide reinforces UCB’s commitment to bring new treatment options to the global ...
Posted by Michael Wonder on 24 Jan 2022
Merck provides US and Japan regulatory update for gefapixant
24 January 2022 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 24 Jan 2022
Chugai’s Actemra approved for additional indication of SARS-CoV-2 pneumonia in Japan
21 January 2022 - The approval is based on the results of several clinical studies in hospitalised patients with COVID-19. ...
Posted by Michael Wonder on 21 Jan 2022
Japan’s MHLW approves Pfizer and OPKO’s Ngenla (somatrogon), a new long-acting treatment for paediatric growth hormone deficiency
20 January 2022 - Ngenla offers a new once weekly treatment option for children living with growth hormone deficiency. ...
Posted by Michael Wonder on 20 Jan 2022
Lumakras (sotorasib) receives approval in Japan for patients with KRAS G12C mutated advanced non-small cell lung cancer
20 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumakras. ...
Posted by Michael Wonder on 20 Jan 2022
Bristol Myers Squibb receives approval for Abecma (idecabtagene vicleucel), the first CAR T therapy approved for the treatment of multiple myeloma in Japan
20 January 2022 - Bristol-Myers Squibb today announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene ...
Posted by Michael Wonder on 07 Jan 2022
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) approved in Japan for patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy
27 December 2021 - First approval in Japan for the Keytruda plus Lenvima combination. ...