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RSS FeedPosted by Michael Wonder on 29 Dec 2021
Valemetostat new drug application submitted in Japan for treatment of patients with adult T-cell leukaemia/lymphoma
28 December 2021 - Submission of orphan drug designated valemetostat based on pivotal phase 2 trial in patients with relapsed/refractory adult T-cell ...
Posted by Michael Wonder on 26 Dec 2021
Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council seeks additional data; aducanumab remains under review
22 December 2021 - Biogen and Eisai today announced that the First Committee on New Drugs of the Pharmaceutical Affairs ...
Posted by Michael Wonder on 26 Dec 2021
Merck and Ridgeback’s molnupiravir, an investigational oral anti-viral COVID-19 treatment, receives special approval for emergency in Japan
24 December 2021 - Molnupiravir, first oral COVID-19 antiviral medicine to receive authorisation in the world, now authorised in U.S., U.K. ...
Posted by Michael Wonder on 19 Dec 2021
Novavax announces submission of new drug application in Japan for approval of COVID-19 vaccine
15 December 2021 - Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for new drug application, to Japan's ...
Posted by Michael Wonder on 14 Dec 2021
Trastuzumab deruxtecan supplemental new drug application submitted in Japan for treatment of patients with HER2 positive metastatic breast cancer
14 December 2021 - Submission based on groundbreaking DESTINY-Breast03 phase 3 trial, in which trastuzumab deruxtecan demonstrated a 72% reduction in ...
Posted by Michael Wonder on 01 Dec 2021
Huyabio International receives regulatory approval for Hiyasta monotherapy of peripheral T-cell lymphoma In Japan
30 November 2021 - This is the second indication for Hiyasta in Japan following adult T-cell leukaemia/lymphoma. ...
Posted by Michael Wonder on 30 Nov 2021
Merck’s Keytruda (pembrolizumab) approved in Japan in combination with chemotherapy for first-line treatment of patients with radically unresectable, advanced or recurrent oesophageal carcinoma
30 November 2021 - Keytruda is now approved for 16 indications in Japan. ...
Posted by Michael Wonder on 28 Nov 2021
Anti-cancer agent Herceptin approved for additional indication of salivary gland cancer
25 November 2021 - Herceptin has been approved as the first drug for salivary gland cancer, for which there is no ...
Posted by Michael Wonder on 27 Nov 2021
Ono receives approval of Opdivo (nivolumab) for expanded use for two indications in Japan
25 November 2021 - Ono Pharmaceutical and Bristol-Myers Squibb today announced that Ono has received the approvals of Opdivo (nivolumab) for ...
Posted by Michael Wonder on 10 Nov 2021
Merck and Ridgeback announce Japanese Government to purchase 1.6 million courses of molnupiravir, an investigational oral COVID-19 anti-viral medicine, upon authorisation or approval
10 November 2021 - Merck and Ridgeback Biotherapeutics today announced that the Japanese government will purchase, upon authorization or approval, approximately ...
Posted by Michael Wonder on 01 Oct 2021
Japan’s MHLW approves Pfizer’s Cibinqo (abrocitinib) for adults and adolescents with moderate to severe atopic dermatitis
1 October 2021 - Pfizer today announced that the Japanese Ministry of Health, Labour and Welfare has approved Cibinqo (abrocitinib), ...
Posted by Michael Wonder on 28 Sep 2021
Saphnelo approved in Japan for systemic lupus erythematosus
28 September 2021 - Saphnelo is a first in class type I interferon receptor antibody shown to reduce overall disease ...
Posted by Michael Wonder on 28 Sep 2021
Fully human anti-TNF alfa monoclonal antibody Humira obtains additional approval for high dose regimen of ulcerative colitis in adult patients and for new regimen in paediatric patients
27 September 2021 - Eisai and EA Pharma announced today the additional approval for a high dose regimen in adult ...
Posted by Michael Wonder on 28 Sep 2021
VFMCRP announces approval for Tavneos (avacopan) for the treatment of ANCA associated vasculitis in Japan
27 September 2021 - Partner Kissei to market Tavneos in Japan, with launch expected as soon as possible following National Health ...
Posted by Michael Wonder on 22 Sep 2021
Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: co-operation toward extracellular vesicle-based products
15 September 2021 - In addition to support academia with regulatory scientific advice, the Pharmaceuticals and Medical Devices Agency' is proactively ...