June 11, 2013
TOKYO, Japan, June 11, 2013 -Astellas Pharma Inc. (TSE: 4503) today announced that AVEO has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) informing the company that FDA cannot approve the New Drug Application (NDA) in its present form for AVEO’s investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).
June 5, 2013
Tokyo, June 5, 2013 - Zeria Pharmaceutical Co., Ltd. (Tokyo: 4559; “Zeria”) and Astellas Pharma Inc. (Tokyo: 4503; “Astellas”) announced today that Acofide® Tablets 100mg (nonproprietary name: acotiamide hydrochloride hydrate; “Acofide”; Zeria’s development code: “Z-338”; Astellas’s development code: “YM443”) for the treatment of functional dyspepsia (FD) will be launched...
June 4, 2013
Tokyo and San Francisco, CA – June 3, 2013 – Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (Nasdaq: MDVN) today announced that after a priority review, Health Canada has approved XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer in the setting of medical or surgical castration who have received docetaxel therapy.
About XTANDI...
May 31, 2013
Tokyo Japan, May 31, 2013 - Nippon Boehringer Ingelheim Co., Ltd. (headquartered in Shinagawa-ku, Tokyo; president, Yoshiaki Aono; hereinafter referred to as “Nippon Boehringer Ingelheim”) and Astellas Pharma Inc. (Tokyo:4503, headquartered in Chuo-ku, Tokyo; president, Yoshihiko Hatanaka; hereinafter referred to as “Astellas”) announced today’s launch of “Micamloâ Combination Tablets BP,” a combination drug of telmisartan 80 mg, a...
May 29, 2013
THOUSAND OAKS, Calif., and TOKYO (May 29, 2013) – Amgen (NASDAQ:AMGN), the world’s largest independent biotechnology company, and Astellas Pharma Inc. (Tokyo Stock Exchange: 4503, “Astellas”), a leading Tokyo-based global pharmaceutical company, today announced the companies have entered into a strategic alliance to provide new medicines to help address serious unmet medical needs of Japanese patients.
The alliance leverages...
May 28, 2013
Tokyo, May 28, 2012 – Astellas Pharma Inc. (Tokyo:4503) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis.
An FDA orphan drug designation provides several benefits to the sponsor including a seven-year market exclusivity from product approval in the U.S. Isavuconazole has been previously granted FDA fast track...
May 24, 2013
Tokyo, Japan and San Francisco, CA – May 24, 2013 – Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) today announced that Astellas has submitted an application for marketing approval of enzalutamide (generic name) to the Ministry of Health, Labour and Welfare in Japan for the treatment of prostate cancer.
Enzalutamide is a novel, once-daily, oral androgen receptor signaling inhibitor. It inhibits multiple steps in...
May 23, 2013
May 16, 2013
CAMBRIDGE, Mass. and TOKYO, Japan, May 15, 2013 - AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced that additional data from the Phase 3 TIVO-1 trial (TIvozanib Versus sOrafenib in 1st line advanced RCC) of investigational agent tivozanib in patients with advanced renal cell carcinoma (RCC) will be presented at the 2013 Annual Meeting of the American Society of Clinical Oncology (...