Latest Eisai Stories

WOODCLIFF LAKE, N.J., April 20, 2012 /PRNewswire/ -- Eisai announced today that the company has amended the licensing agreement with Teikoku Pharma USA, Inc. (TPU), a subsidiary of Teikoku Seiyaku Co., Ltd., pertaining to exclusive overseas marketing rights for the Aricept® patch (once weekly donepezil HCl transdermal system). (Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO) The amendment allows TPU to be solely responsible for making all decisions regarding future...

WOODCLIFF LAKE, N.J., April 18, 2012 /PRNewswire/ -- Eisai Inc. announced today that the results of the study, "Randomized Phase III Study 306: Adjunctive Perampanel for Refractory Partial-Onset Seizures," were published online today in the April 18, 2012, edition of Neurology®. (Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO) Marketing authorization applications for perampanel are currently under review with the U.S. Food and Drug Administration and the...

EXTON, Pa., April 16, 2012 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has commenced a multi-center, Phase II study evaluating the safety and efficacy of MORAb-004 in the treatment of metastatic colorectal cancer that is refractory to all standard therapy. MORAb-004 is a monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1). The trial is a randomized, double-blind, placebo-controlled study to assess...

Tokyo, Apr 3, 2012 - (JCN Newswire) - Eisai Co., Ltd. and its diagnostics subsidiary EIDIA Co., Ltd. announced today that EIDIA entered into two separate agreements with medical equipment manufacturers Toshiba Medical Systems Corporation and GE Healthcare Japan Corporation on April 2 for Japan sales of PROTOCO2L, a carbon dioxide insufflation system for CT (computed tomographic) colonography, and carbon dioxide insufflation tube PROTOCO2L Catheter Set...

Observations: How the FDA forgot the evidence: The case of donepezil 23 mg Approval for a new dose of a best-selling Alzheimer's drug "breached the FDA's own regulatory standard" and has led to "incomplete and distorted messages" about the drug, warn experts on bmj.com today. In the first of a new occasional series, "not so", highlighting the exaggerations, distortions, and selective reporting that mark some news stories, advertising, and medical journal articles, Lisa M. Schwartx and...

Tokyo, Jan 18, 2012 - (JCN Newswire) - Eisai Co. Ltd announced today that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. ("Sunovion"; formerly Sepracor Inc., "Sepracor"; a U.S. subsidiary of Dainippon Sumitomo Pharma Co....

Tokyo, Jan 16, 2012 - (JCN Newswire) - Nobelpharma Co. Ltd and Eisai Co. Ltd announced today that they will launch the anticonvulsant agent Fostoin 750 mg for Injection (fosphenytoin sodium hydrate, "fostoin") on January 17. Developed in Japan by Nobelpharma, Fostoin will be marketed by Eisai and co-promoted by both companies under a previously concluded marketing agreement.Fostoin is a water-soluble prodrug of phenytoin injection, a drug that has long been used...

Tokyo, Dec 26, 2011 - (JCN Newswire) - Eisai Co. Ltd announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011 (U.S. eastern standard time). This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of...

Tokyo, Dec 21, 2011 - (JCN Newswire) - Eisai Co. Ltd announced today that its pharmaceutical manufacturing and marketing subsidiary Sannova Co. Ltd submitted an application for partial change to the approved label for egg white lysozyme preparation Neuzym to Japan's Ministry of Health, Labour and Welfare (MHLW) on December 21, 2011. The company is seeking approval to remove alveolar pyorrhea and other conditions as approved indications for the product as well as...

Tokyo, Dec 13, 2011 - (JCN Newswire) - Eisai Co. Ltd today submitted a marketing and manufacturing authorization application to Japan's Ministry of Health, Labour and Welfare seeking approval of a new dry syrup formulation of its Alzheimer's disease (AD) treatment Aricept (donepezil hydrochloride).In August 2007, the indication of Aricept was expanded to include severe AD. The simultaneous approval of additional dosage, which states that once daily dosage of...