|
| Tuesday, January 9, 2018 |
|
|
Eisai and Merck & Co. Receive Breakthrough Therapy Designation from U.S. FDA for LENVIMA and KEYTRUDA |
| The LENVIMA and KEYTRUDA combination therapy is being jointly developed by Eisai and MSD. This is the second Breakthrough Therapy Designation for LENVIMA and the twelfth Breakthrough Therapy Designation granted to KEYTRUDA. more info >> |
|
|
バイオジェンとエーザイが多発性硬化症治療剤の共同販促を開始 |
| バイオジェンとエーザイが多発性硬化症治療剤の共同販促を開始 more info >> |
|
|
エーザイとMSD、「レンビマ」と「キイトルーダ」併用療法について米国FDAよりブレイクスルーセラピーの指定を受領 |
| エーザイ株式会社（本社：東京都、代表執行役 CEO：内藤晴夫）と Merck & Co., Inc., Kenilworth, N.J., U.S.A.（NYSE：MRK、米国とカナダ以外では MSD）は、このたび、エーザイ創製のマルチキナーゼ阻害剤「レンビマ(R)」（一般名：レンバチニブメシル酸塩）とMSD の抗 PD-1 抗体「キイトルーダ(R)」（一般名：ペムブロリズマブ）との併用療法による進行性または転移性腎細胞がんの適応に対して、米国食品医薬品局（FDA）よりブレイクスルーセラピーの指定を受けましたのでお知らせします。 more info >> |
|
| Wednesday, December 27, 2017 |
|
|
エーザイ、抗がん剤レンバチニブが中国 国家食品薬品監督管理総局より肝細胞がんに係る適応について優先審査に指定 |
| エーザイ株式会社（本社：東京都、代表執行役 CEO：内藤晴夫）は、このたび、中国で 2017 年 10 月に申請した自社創製の抗がん剤レンバチニブメシル酸塩 (一般名、製品名： 「レンビマ(R)」「Kisplyx(R)」、以下 レンバチニブ)の肝細胞がんに係る適応について、国家食品薬品監督管理総局（CFDA）より、既存の治療に比べ治療上の顕著なメリットを有するとして、優先審査に指定されましたのでお知らせします。 more info >> |
|
|
Eisai: Anticancer Agent Lenvatinib Designated for Priority Review and Approval by CFDA for Hepatocellular Carcinoma |
| Eisai Co., Ltd. announced that its in-house discovered and developed anticancer agent lenvatinib mesylate for use in the treatment of HCC, which was submitted for approval in China in October 2017, has been designated for Priority Review and Approval by CFDA due to lenvatinib's significant clinical benefit compared to existing treatments. more info >> |
|
| Friday, December 22, 2017 |
|
|
エーザイ、BAN2401の早期アルツハイマー病を対象としたアダプティブ臨床第II相試験を18カ月のエンドポイントに向け継続 |
| エーザイ株式会社とバイオジェン・インクは、このたび、抗アミロイドβ（Aβ）プロトフィブリル抗体 BAN2401 について、患者様 856 人による臨床第II相試験（201試験）の 12 カ月時点の解析において、ベイジアン解析に基づく成功基準である主要評価項目を満たさなかったと独立データモニタリング委員会が判断したことをお知らせします。 more info >> |
|
|
Eisai: Adaptive Phase II Study of BAN2401 In Early Alzheimer's Disease Continues Toward 18-Month Endpoint |
| Eisai Co., Ltd. and Biogen Inc. announced today that an Independent Data Monitoring Committee has determined that BAN2401, an anti-amyloid beta protofibril antibody, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient Phase II clinical study (Study 201). more info >> |
|
| Monday, December 18, 2017 |
|
|
Eisai Launches Educational Materials for Understanding Dementia |
| Eisai Co., Ltd. announced that it has created educational materials for understanding dementia and thinking about what one can do for elementary and secondary school students, and has commenced marketing these materials primarily to local governments, educational institutions as well as medical and nursing care professionals from today. more info >> |
|
| Wednesday, March 31, 2021 |
|
|
KYORIN and Eisai Enter Into License Agreement Concerning the Development and Marketing of Vibegron, a Treatment for Overactive Bladder, in Four ASEAN Countries |
| KYORIN Pharmaceutical Co., Ltd., a subsidiary of KYORIN Holdings, Inc., and Eisai Co., Ltd. have entered into a license agreement for development and distribution of vibegron, a therapeutic agent for overactive bladder, in four ASEAN (Association of Southeast Asian Nations) member states; Thailand, the Philippines, Malaysia and Brunei. more info >> |
|
|
Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Renal Cell Carcinoma in Japan |
| Eisai Co., Ltd. and MSD K.K. a subsidiary of Merck & Co., Inc., (known as MSD outside the United States and Canada) announced today that Eisai has submitted an application in Japan for the additional indication of its in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA. more info >> |
|
|
|
|
