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| Tuesday, October 4, 2016 |
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BELVIQ XR - a New Once-daily Formulation of BELVIQ for Chronic Weight Management Now Available in the United States |
| Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has launched BELVIQ XR 20mg tablets, a new once-daily formulation of BELVIQ (generic name: lorcaserin hydrochloride) for chronic weight management in the United States. more info >> |
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| Friday, September 30, 2016 |
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エーザイ、抗がん剤「レンバチニブ」の進行性腎細胞がん一次治療対象の臨床第III相試験を開始 |
| 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、自社創製のマルチキナーゼ阻害剤レンバチニブメシル酸塩と抗がん剤エベロリムスまたは抗PD-1抗体ペムブロリズマブとの2つの併用療法に関して、進行性腎細胞がんの一次治療を対象としたグローバル臨床第III相試験（307試験、CLEAR試験）を開始することをお知らせします。 more info >> |
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Eisai to Initiate Phase III Clinical Study of Anti-Cancer Agent Lenvatinib as Potential First-Line Therapy for Advanced Renal Cell Carcinoma |
| Eisai Co., Ltd. announced ienttoday the initiation of a global Phase III Clinical Study (Study 307, CLEAR Study) of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in respective combination regimens with the anticancer agent everolimus and the anti-PD-1 antibody pembrolizumab as a potential first-line treatment for advanced renal cell carcinoma. more info >> |
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| Thursday, September 29, 2016 |
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Eisai to Present Latest Data on Lenvatinib and Eribulin at ESMO Congress 2016 |
| Eisai Co., Ltd. announced today that a series of abstracts highlighting the latest clinical and pre-clinical data on lenvatinib mesylate and eribulin mesylate will be presented during the European Society for Medical Oncology (ESMO) Congress 2016 more info >> |
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| Wednesday, September 28, 2016 |
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AbbVie and Eisai Obtain Additional Approval for New Indication of Fully Human Anti-TNF-alpha Monoclonal Antibody HUMIRA in the Treatment of non-infectious Uveitis |
| AbbVie GK and Eisai Co., Ltd. today announced the additional approval for a new indication of HUMIRA, a fully human anti-TNF-alha monoclonal antibody formulation, in the treatment of non-infectious intermediate, posterior and panuveitis. more info >> |
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Eisai Commences Provision of "EMILY" Smartphone App to Support Living with Epilepsy in Japan |
| Eisai Co., Ltd. announced today that it has commenced provision of the "EMILY" smartphone app in Japan to enable people with epilepsy and their families to enjoy greater peace of mind. more info >> |
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Eisai Submits Supplemental Application for Partial Label Change for Antiepileptic Drug Fycompa |
Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has submitted a supplemental application for its in-house-discovered antiepileptic drug (AED) Fycompa (perampanel) proposing the inclusion in labelling of a description of use as monotherapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older to the U.S Food and Drug Administration (FDA) based on new FDA policy.
more info >> |
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| Tuesday, September 27, 2016 |
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エーザイ、抗てんかん剤「Fycompa」 部分てんかんの単剤療法での使用に関する一部変更申請を米国FDAの新ポリシーに基づいて提出 |
| エーザイ株式会社は、このたび、米国子会社のエーザイ・インクが、自社創製の抗てんかん剤 「Fycompa(R)」について、米国食品医薬品局(FDA)の新ポリシーに基づき、12歳以上のてんかん患者様の部分発作（二次性全般化発作を含む）に対する単剤療法での使用を追加した添付文書案を含む一部変更申請をFDAに提出したことをお知らせします。 more info >> |
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| Thursday, September 15, 2016 |
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エーザイ、抗がん剤「Kisplyx」が欧州において新たに進行性腎細胞がんに関する適応の承認を取得 |
| エーザイ株式会社は、このたび、欧州統括会社エーザイ・ヨーロッパ・リミテッドが、自社創製の新規抗がん剤「Kisplyx(R)」について、欧州委員会より、「血管内皮増殖因子を標的とした薬剤の前治療歴を有する成人での進行性腎細胞がんに対するエベロリムスとの併用療法」の適応で承認を取得しましたのでお知らせします。 more info >> |
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Eisai Receives License for New Indication for Anticancer Agent Kisplyx (Lenvatinib Mesylate) for Treatment of Advanced Renal Cell Carcinoma |
| Eisai Co., Ltd. announced that its European regional headquarters Eisai Europe Ltd. has received license from the European Commission for anticancer agent Kisplyx in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy. more info >> |
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