Eisai Co Ltd (ESALF) 58.2500 $ESALF Eisai Receives

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Eisai Co Ltd (ESALF) 58.2500 $ESALF

Eisai Receives Positive CHMP Opinion on New Indication for Anticancer Agent Lenvatinib in Combination with Everolimus for Treatment of Advanced Renal Cell Carcinoma
JCN Newswire - Fri Jul 22, 7:48AM CDT
Eisai Co., Ltd. announced today that its European regional headquarters Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on anticancer agent lenvatinib mesylate in combination with everolimus. It's for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF) targeted therapy. If approved, lenvatinib will be launched under the brand name Kisplyx for this indication. The CHMP's positive opinion was based on a Phase II clinical study (Study 205)(1) that evaluated the safety and efficacy of lenvatinib in combination with everolimus in patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted therapy. From the results of the study, the group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival, the study's primary endpoint, as well as a higher objective response rate compared to the everolimus alone group. The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhea, hypertension and fatigue. The number of patients with renal cancer in Europe is estimated to be 115,000,2 and renal cell carcinoma comprises more than 90% of all malignancies of the kidney.3 For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

Eisai Enters into a Collaboration Agreement to Co-Promote LENVIMA® (Lenvatinib) in Combination with Everolimus in the U.S.
PR Newswire - Thu Jun 02, 3:15PM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., and Novartis Pharmaceuticals Corporation, an affiliate of Basel, Switzerland-based Novartis AG, have entered into an agreement to collaborate on commercial and medical affairs activities for LENVIMA® capsules in combination with everolimus in the United States for the treatment of patients with advanced renal cell carcinoma (aRCC), who were previously treated with an anti-angiogenic therapy.
NVS: 83.26 (+1.18)

Eisai to Launch In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate)
JCN Newswire - Wed May 25, 6:38AM CDT


Maria Garrigan appointed Vice President, Global Regulatory Strategy, Oncology Business Group at Eisai Inc.
PR Newswire - Tue May 24, 7:00AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Maria Garrigan, as Vice President, Global Regulatory Strategy for the Oncology Business Group (OBG).

Eisai to Present New Research on Oncology Products and Pipeline at 52nd Asco Annual Meeting
JCN Newswire - Mon May 23, 8:36PM CDT
TOKYO, May 24, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that a series of abstracts highlighting new study results on Halaven (eribulin mesylate; halichondrin class microtubule dynamics inhibitor, "eribulin" and Lenvima (lenvatinib mesylate; selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, "lenvatinib" will be presented during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, the United States, from June 3 to 7, 2016.

U.S. FDA Approves Additional Indication for Eisai's Anticancer Agent Lenvima in Combination with Everolimus as Treatment for Advanced Renal Cell Carcinoma
JCN Newswire - Sun May 15, 10:44PM CDT
TOKYO, May 16, 2016 - (JCN Newswire) - 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 additional indication for Eisai's in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. This is the only combination regimen to significantly prolong progression-free survival (PFS) when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy. Lenvima was designated as a Breakthrough Therapy by the FDA and also received a Priority Review, with approval obtained approximately six months after application submission.

Dr. Avinash Desai appointed Vice President, Americas Oncology Medical Affairs, Oncology Business Group at Eisai Inc.
PR Newswire - Wed Apr 20, 7:00AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Avinash Desai, MD, as Vice President, Americas Oncology Medical Affairs for the Oncology Business Group (OBG).

Beyhan Zaim appointed Vice President Commercial Development & Alzheimer's Disease Global Lead, Neurology Business Group at Eisai Inc.
PR Newswire - Mon Apr 11, 7:00AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Beyhan Zaim as Vice President Commercial Development & Alzheimer's Disease Global Lead, Neurology Business Group.

Paul Hawthorne appointed Senior Vice President, U.S. Commercial, Neurology Business Group at Eisai Inc.
PR Newswire - Wed Apr 06, 7:00AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Paul Hawthorne to the position of Senior Vice President, U.S. Commercial, Neurology Business Group. In this role, Mr. Hawthorne will be responsible for leading the U.S. Neurology Sales and Marketing teams in bringing Eisai's neurology portfolio of products to patients.

Eisai Receives Positive CHMP Opinion on New Indicator for Anticancer Agent Halaven for Treatment of Advanced Liposarcoma
JCN Newswire - Mon Apr 04, 8:11PM CDT
TOKYO, Apr 5, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that its European regional headquarters Eisai Europe Ltd. (Location: U.K.) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on anticancer agent Halaven (eribulin mesylate) for treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. Halaven is the first and only single agent to demonstrate an overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). Following approval for use in the treatment of metastatic breast cancer in the EU, this marks the second indication for which Halaven has received a positive CHMP opinion based on a statistically significant extension of OS.

Eisai Transfer the Rights to Investigational Anticancer Agent E7777 for European, U.S and Certain Emerging Markets to Dr. Reddy's Laboratories
JCN Newswire - Thu Mar 31, 3:34AM CDT
TOKYO, Mar 31, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that it has entered into an agreement to transfer the exclusive worldwide development and marketing rights (excluding Japan and Asia) for its investigational anticancer agent E7777 to Dr. Reddy's Laboratories Ltd. (Dr. Reddy's).
RDY: 43.65 (+0.04)

Eisai's Notice Concerning Shelf Registration for Issuance of Stock Options
JCN Newswire - Wed Mar 30, 10:27PM CDT
TOKYO, Mar 30, 2016 - (JCN Newswire) - Eisai Co., Ltd. ("the Company" today filed a shelf registration statement with the Kanto Local Finance Bureau for issuance of stock options in accordance with the Company's "Policy for Protection of the Company's Corporate Value and Common Interests of Shareholders" ("the Policy" .This submission corresponds to the expiration of the previous shelf registration (period from April 7, 2014 to April 6, 2016) filed on March 28, 2014.

Eisai Co., Ltd. and Ajinomoto Co., Inc. Announce Establishment of Gastrointestinal Specialty Pharma EA Pharma Co., Ltd.
JCN Newswire - Wed Mar 30, 9:35PM CDT


Eisai's Notification Regarding Revision of Consolidated Financial Results Forecasts (IFRS) for the Fiscal Year Ending March 31, 2016
JCN Newswire - Wed Mar 30, 9:35PM CDT
TOKYO, Mar 30, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that based on recent trends in business results, etc., the company has revised its full-year consolidated financial results forecasts for the fiscal year ending March 31, 2016 (April 1, 2015 to March 31, 2016) previously announced on February 2, 2016, as follows:

Global Drug Maker Eisai Signs Three-Year Contract Extension For CSC's Total Regulatory Solution (TRS) as-a-Service
BusinessWire - Wed Mar 30, 9:00AM CDT
CSC (NYSE: CSC), a global leader in next-generation IT services and solutions, announced today that Eisai Inc. has signed a three-year contract extension for CSC's Total Regulatory Solutions (TRS) as-a-Service. The agreement extends the ongoing life sciences software and cloud-hosting services CSC provides to Tokyo-based Eisai Co., Ltd.'s U.S. pharmaceutical subsidiary until December 2019.
CSC: 47.83 (+0.13)

Eisai's In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate) Approved in Japan
JCN Newswire - Mon Mar 28, 10:07PM CDT


Eisai Withdraws New Drugs Application for Mecobalamin Ultra-High Dose Preparation as Treatment for Amyotrophic Lateral Sclerosis
JCN Newswire - Tue Mar 22, 2:17AM CDT
TOKYO, Mar 22, 2016 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that it has withdrawn its new drug application for ultra-high dose Mecobalamin development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan.

Helsinn and Eisai Announce Revised U.S. Collaboration for CINV Franchise
PR Newswire - Fri Mar 18, 6:55AM CDT
Helsinn, the Swiss pharmaceutical Group focused on building quality cancer care, and Eisai Inc., the U.S. pharmaceutical subsidiary of the research-based human healthcare company Eisai Co., Ltd , announced today a revised agreement for their chemotherapy-induced nausea and vomiting (CINV) franchise.

Notice Regarding Discontinuation of Sales and Voluntary Recall of Egg White Lysozyme Preparation Neuzym
JCN Newswire - Thu Mar 17, 7:11AM CDT


Global Obesity Pipeline Review, H2 2015 - Therapeutics Under Development by Leading Companies and Universities
M2 - Tue Feb 09, 8:28AM CST
Research and Markets (http://www.researchandmarkets.com/research/4fs2cn/obesity) has announced the addition of the "Obesity - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Multiple Myeloma (Kahler Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Obesityand special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - ObesityOverview - Therapeutics Development - Pipeline Products for Obesity - Overview - Pipeline Products for Obesity - Comparative Analysis - Obesity - Therapeutics under Development by Companies - Obesity - Therapeutics under Investigation by Universities/Institutes - Obesity - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Obesity - Products under Development by Companies - Obesity - Products under Investigation by Universities/Institutes - Obesity - Companies Involved in Therapeutics Development Companies Mentioned - Sample List of the 35 Companies Featured - Abeome Corporation - Advinus Therapeutics Ltd. - Aegis Therapeutics, LLC - Akron Molecules AG - Alize Pharma SAS - Amabiotics SAS - Ambrx, Inc. - Amgen Inc. - Arena Pharmaceuticals, Inc. - Arrien Pharmaceuticals, LLC - AstraZeneca Plc - Asubio Pharma Co., Ltd. - AtheroNova Inc. - Avaxia Biologics, Inc. - BioLingus AG - BioRestorative Therapies, Inc. - BioTime, Inc. - Boehringer Ingelheim GmbH - Braasch Biotech LLC - Bristol-Myers Squibb Company - Camurus AB - Carmot Therapeutics, Inc. - Chronos Therapeutics Limited - CohBar, Inc. - CoMentis, Inc. - Daiichi Sankyo Company, Limited - Deltanoid Pharmaceuticals Inc. - Diabetica Limited - DiscoveryBiomed, Inc. - Eisai Co., Ltd. - Eli Lilly and Company - Esperion Therapeutics, Inc. - Euroscreen S.A. - F. Hoffmann-La Roche Ltd. - FibroGen, Inc. For more information visit http://www.researchandmarkets.com/research/4fs2cn/obesity
AMBX: (), AMGN: 172.03 (+0.75), LLY: 82.89 (-0.04), BMY: 74.81 (+0.15), ESPR: 10.86 (unch), AZN: 34.14 (-0.15), FGEN: 19.13 (+0.20), ARNA: 1.67 (-0.01)

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