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U.S. FDA DESIGNATES FOR PRIORITY REVIEW EISAI’S SUPPLEMENTAL NEW DRUG APPLICATION FOR ANTIEPILEPTIC DRUG FYCOMPA? AS TREATMENT FOR PEDIATRIC PATIENTS WITH EPILEPSY

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai‘s antiepileptic drug (AED) Fycompa?(perampanel). This application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (PGTC) seizures. Furthermore, Eisai has included a study in this sNDA requested by the FDA in a Pediatric Written Request, and therefore FDA has designated this application for Priority Review, which means the review period will be six months. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of September 28, 2018.?

2018/5/31 by

Eisai China Won the “Best HR Teams in Greater China” of HRoot Awards 2018

On May 29, the China Human Capital Forum 2018 was held in China World Hotel Beijing, announcing that the human resource team of Eisai China won the “Best HR Teams in Greater China” of?HRoot Awards?2018 for their outstanding achievements and contributions in pushing the development and innovation of the corporate, building excellent workplaces and promoting business development. Mr. Yamada Koki, Head of Pharmaceutical Affairs Division of Eisai China, Mr. Yu Ruilong, Director of Drug Affairs & Relationship Department of Eisai China, and Ms. Wang Li, Manager of Human Resource Department of Eisai China attended the award ceremony.?

2018/5/29 by

The Eisai China Scholarships Program Supports China’s Education for 18 Consecutive Years

It has been 18 years since Eisai China launched the Eisai China Scholarships Program (hereafter referred to as “the Program”) in 2000. A total of approximately 7.29 million RMB has been contributed to seven universities in China to support more than 1,500 outstanding students and those in straitened circumstances. The 7 universities include Sun Yat-sen University, Medical College of Soochow University, School of Basic Medical Sciences of Fudan University, Peking University Health Science Center, China Medical University, West China Medical Center of Sichuan University as well as School of Pharmacy of Shenyang Pharmaceutical University.

2018/4/26 by

World’s First Bile Acid Transporter Inhibitor “GOOFICE? 5mg Tablet” Launched in Japan

Eisai Co., Ltd. (CEO: Haruo Naito; Headquarters: Tokyo, Japan) (hereinafter “Eisai”), Eisai‘s subsidiary for gastrointestinal diseases EA Pharma Co., Ltd. (President & CEO: Yuji Matsue; Headquarters: Tokyo, Japan) (hereinafter “EA Pharma”) and Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida; Headquarters: Tokyo, Japan) (hereinafter “Mochida”) today announced that the bile acid transporter inhibitor “GOOFICE??5mg Tablet” (nonproprietary name: elobixibat hydrate; development code: AJG533) (hereinafter “GOOFICE??Tablet”) was listed in Japan’s National Health Insurance Drug Price List as of April 18, 2018, and EA Pharma and Mochida launched the product onto Japan‘s market today.

2018/4/19 by

Anticancer Agent LENVIMA? Approved for Additional Indication of Unresectable Hepatocellular Carcinoma (HCC) in Japan, First Approval Worldwide for LENVIMA for HCC

TOKYO March 23, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), today announced that the multiple receptor tyrosine kinase inhibitor LENVIMA??(generic name: lenvatinib mesylate) has been approved in Japan for unresectable hepatocellular carcinoma (HCC). This is the first approval worldwide for LENVIMA for the indication of unresectable HCC and the first new systemic therapy to be approved in Japan for the front-line treatment of HCC in approximately 10 years. Additionally, this is the first regulatory approval for LENVIMA under the global strategic collaboration agreement executed in March 2018 between Eisai and Merck & Co., Inc., Kenilworth N.J., U.S.A. for the co-development and co-commercialization of LENVIMA.

2018/3/23 by

Innovation, Joint efforts, Defense — Shinsei Electronics management visited Eisai (China) headquarter

On March 12th, a group of executives from Shinsei Electronics Co., Ltd., inclusive of President Yamashita Noriyuki, Division Head Isobe Takashi, and etc., visited Eisai (China) headquarter and had friendly and cordial talks with the management staff of Eisai (China). The two parties reached a strategic cooperation agreement on “ICG Clearance Meter,” and Eisai (China) will become the exclusive distributor of the product in China which will be jointly promoted with Indocyanine Green for Injection, a product of Eisai (Liaoning) Pharmaceutical Co., Ltd.

2018/3/12 by

ANTICANCER AGENT LENVATINIB DESIGNATED FOR PRIORITY REVIEW AND APPROVAL BY CHINA FOOD AND DRUG ADMINISTRATION FOR HEPATOCELLULAR CARCINOMA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima? / Kisplyx?, “lenvatinib”) for use in the treatment of hepatocellular carcinoma (HCC), which was submitted for approval in China in October 2017, has been designated for Priority Review and Approval by the China Food and Drug Administration (CFDA) due to lenvatinib‘s significant clinical benefit compared to existing treatments.

2017/12/27 by