Blog
RSS FeedPosted 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. ...
Posted 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. ...