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| Press Releases |
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| Wednesday, July 29, 2015 |
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Eisai's In-House Developed Novel Anticancer Agent Lenvima Receives Breakthrough Therapy Designation From U.S. Fda for Renal Cell Carcinoma |
| Eisai Co., Ltd. announced today its U.S. subsidiary Eisai Inc. has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its in-house developed novel anticancer agent Lenvima for the potential indication of advanced and/or metastatic renal cell carcinoma. more info >> |
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| Friday, June 26, 2015 |
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Eisai to Launch New Fine Granule Formulation of Tachyarrhythmia Treatment Tambocor Suitable for Pediatric Patients in Japan |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it will launch Tambocor Fine Granules 10%, a new formulation of anti-arrhythmic agent Tambocor (flecainide acetate), on June 29 in Japan. more info >> |
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| Monday, June 22, 2015 |
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U.S. FDA Approves Eisai's Antiepileptic Agent Fycompa as Adjunctive Treatment For Primary Generalized Tonic-Clonic Seizures |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. more info >> |
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| Monday, June 1, 2015 |
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Eisai Receives European Commission Approval of Anticancer Agent Lenvima for Treatment of Advanced Thyroid Cancer Refractory to Radioactive Iodine |
| Eisai Co., Ltd. announced today that its U.K. subsidiary Eisai Europe Ltd. has received approval from the European Commission (EC) for anticancer agent Lenvima (lenvatinib mesylate) in the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hurthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). more info >> |
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| Friday, May 29, 2015 |
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AbbVie and Eisai Clear All-Case Surveillance Condition for Approval of HUMIRA, a Fully Human Anti-TNF-alpha Monoclonal Antibody, in the Treatment of Ankylosing Spondylitis |
| AbbVie GK and Eisai Co., Ltd. announced today that they have received notification from Japan's Ministry of Health, Labour and Welfare (MHLW) to the effect that the "all-case surveillance" special drug use-results survey condition required for approval of HUMIRA Pre-filled Syringe 40 mg / 0.8 mL, a fully human anti-TNF-alpha monoclonal antibody formulation, has been lifted for use in patients with ankylosing spondylitis. more info >> |
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| Wednesday, May 27, 2015 |
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Eisai Submits New Drug Application for Mecobalamin Ultra-High Dose Preparation as Treatment for Amyotrophic Lateral Sclerosis in Japan |
| Eisai Co., Ltd. announced today that it has submitted a new drug application for mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan. more info >> |
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Eisai Receives Positive CHMP Opinion on Indication Expansion for Antiepileptic Agent Fycompa (Perampanel) as Adjunctive Treatment of Primary Generalized Tonic-Clonic Seizures |
| Eisai Co., Ltd. announced today that its U.K. subsidiary Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa (perampanel) for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in adult and adolescent patients from 12 years of age with idiopathic generalized epilepsy. more info >> |
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| Thursday, May 21, 2015 |
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Eisai to Promote Clinical Trial Data Disclosure for The Advancement of Science and Medicine |
| Eisai Co., Ltd. has announced today that, in order to further promote transparency in clinical trial data disclosure, it has determined its policy on clinical trial data disclosure and is making clinical trial data publicly available to researchers via an external website (www.clinicalstudydatarequest.com). more info >> |
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| Wednesday, May 20, 2015 |
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Eisai Launches In-house Developed Novel Anticancer Agent Lenvima (Lenvatinib Mesylate) as Treatment for Unresectable Thyroid Cancer in Japan |
| Eisai Co., Ltd. announced that it has launched its in-house developed novel anticancer agent Lenvima Capsule 4 mg and 10 mg as a treatment for unresectable thyroid cancer in Japan on May 20, 2015. more info >> |
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| Thursday, May 14, 2015 |
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Eisai to Present New Research on Oncology Products and Pipeline at 51st ASCO Annual Meeting |
Eisai Co., Ltd. announced today that a series of abstracts highlighting new study results on Halaven and Lenvima will be presented during the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, the United States, from May 29 to June 2, 2015.
more info >> |
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