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| Monday, October 1, 2018 |
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Eisai's Fycompa Newly Approved by U.S. FDA as Treatment for Partial-Onset Seizures in Pediatric Patients with Epilepsy |
| Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. FDA for an indication expansion for Eisai's antiepileptic drug (AED) Fycompa (perampanel) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older. Fycompa was designated for Priority Review by the FDA, and was approved approximately six months after submission. more info >> |
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| Wednesday, September 5, 2018 |
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Eisai And Merck & Co. Announce China NMPA Approval of First Approval for LENVIMA (Lenvatinib) for Treatment of Unresectable HCC |
| Eisai Co., Ltd. and Merck & Co. known as MSD outside of the United States and Canada, announced that the China National Medical Products Administration (NMPA) approved the kinase inhibitor LENVIMA (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. more info >> |
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| Monday, September 3, 2018 |
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Eisai Receives Approval for Partial Label Change for Vascular Embolization Device DC Bead |
| Eisai Co., Ltd. announced that it has received approval for a partial label change for the vascular embolization device DC Bead (specially controlled medical device) in Japan. more info >> |
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| Thursday, August 30, 2018 |
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Eisai's LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South Korea |
| Eisai Co., Ltd. announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) from the Ministry of Food and Drug Safety (MFDS) in South Korea. more info >> |
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| Wednesday, August 29, 2018 |
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Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab |
| Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension (LTE) Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. more info >> |
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| Tuesday, August 28, 2018 |
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Eisai: Long-Term Cardiovascular Outcomes Data for Anti-Obesity Agent BELVIQ |
| The average change in weight from baseline was -4.2 kg with BELVIQ and -1.4 kg with placebo, translating to a 2.8 kg greater net weight loss with BELVIQ (nominal p-value<0.001). more info >> |
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| Thursday, August 23, 2018 |
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Eisai: European Commission Grants Marketing Authorization for LENVIMA (Lenvatinib) |
| This is the first new first-line treatment option for advanced or unresectable HCC to be approved in Europe in approximately 10 years. more info >> |
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| Tuesday, July 31, 2018 |
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Eisai Signs Collaboration Agreement for Anti-Obesity Agent Lorcaserin in China to CY Biotech |
| Under this agreement, Eisai will supply CYB with lorcaserin. Eisai will receive a one-time contractual payment and milestone payments dependent upon acquisition of regulatory approval. more info >> |
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Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Announce U.S. FDA Grants Breakthrough Therapy Designation for LENVIMA |
| The LENVIMA/KEYTRUDA combination therapy is being jointly developed by Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. as part of the strategic collaboration announced in March 2018. more info >> |
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| Thursday, July 26, 2018 |
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Eisai and Biogen Announce Detailed Results of Phase II Clinical Study of BAN2401 in Early Alzheimer's Disease at AAIC 2018 |
| Eisai Co., Ltd. and Biogen Inc. announced detailed results from the Phase II study (Study 201) with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease as part of Session DT-01 "Recent Developments in Therapeutics" at AAIC 2018 being held in Chicago, Illinois, United States on July 25. more info >> |
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