Detail|Japan Pharmaceutical Information Center Clinical Trial Information http://www.clinicaltrials.jp/user/cteDetail_e.jsp[2010/08/23 10:21:07] ?Basic information JapicCTI-No. JapicCTI-101246 ?Title of the study Title of the study A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome Public title of the study Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE) Primary sponsor Takeda Global Research & Development Center, Inc.,* Secondary sponsor Study Type interventional (drug) Summary The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in subjects with type 2 diabetes mellitus and acute coronary syndrome. ?Details of the study Disease or condition Diabetes Mellitus, Ty
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OSAKA, Japan, August 20, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that an additional indication for “NESINA®” (generic name: Alogliptin), combination therapy with thiazolidinediones for type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare.
OSAKA, Japan, June 15, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it launched “NESINA®” (generic name: Alogliptin) for treatment of type 2 diabetes, “UNISIA®” (generic name: Candesartan Cilexetil / Amlodipine Besilate) for treatment of hypertension and “Vectibix®” (generic name: Panitumumab), anti-cancer agent.
OSAKA, Japan, April 16, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that New Drug Applications for five new products were approved on April 16 by the Japanese Ministry of Health, Labour and Welfare. Five new products approved for commercial sale in Japan comprise three new medical entities; “NESINA®” for treatment of type 2 diabetes, “ROZEREM®” for treatment of insomnia and anti-cancer agent “Vectibix®”, and two fixed dose combinations; “METACT®” for treatment of type 2 diabetes and “UNISIA®” for treatment of hypertension, each of them contains two compounds with a different mechanism of action respectively.
OSAKA, Japan, March 25, 2010 – Takeda Pharmaceutical Company Limited (Takeda) today announced that it submitted an application for additional indications of alogliptin (generic name, development code: SYR-322) for combination therapy with sulfonylurea and combination therapy with biguanide to the Ministry of Health, Labour and Welfare in Japan.
Publications of Takeda Research Laboratories 2009 July 2010 武田研究業績集 2 0 0 9 武 田 薬 品 工 業 株 式 会 社 Takeda Pharmaceutical Company Limited Osaka, Japan CONTENTS Originals in English Analytical Chemistry 1 Organic Chemistry 1 Medicinal Chemistry 1 Biochemistry and Biotechnology 3 Pharmacology 3 Basic Biology and Physiology 5 Drug Safety Evaluation 6 Information Science 7 Originals in Japanese Medicinal Chemistry 8 Pharmacology 8 Pharmaceutics 9 Drug Safety Evaluation 9 Clinical Research 9 Technology and Development 9 Author Index 11 1 Originals in English Analytical Chemistry [T1] The Influence of Water on the Stability of Lyophilized Formulations with Inositol and Mannitol as Excipients Akira Terakita, Hirokazu Matsunaga and Tetsuro Handaa Chem. Pharm. Bull., 57, 459-463 (2009) 寺北 晃、松永浩和、半田哲郎 a Graduate School of Pharmaceutical Sciences, Kyoto University, 46-29 Yoshida-Shimo-Adachi-cho, Sakyo-ku, Kyoto 606-8501, Japan Organic Chemistry [T2] Synthesis of Melatonin Receptor Agonist Ram
DEERFIELD, Ill., and OSAKA, Japan, August 28, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.
DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.
Osaka, Japan, June 4, 2009 -Takeda Pharmaceutical Company Limited ("Takeda") announced today that it has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone HCl), in Europe, and accordingly, has initiated an additional long-term clinical study for alogliptin.
OSAKA, Japan, March 6, 2009 - Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.
ANNUALREPORT2008 Annual Report 2008 Our Contribution to Financial and Social Responsibility TakedaPharmaceuticalCompanyLimited Contributes to The Health of Individuals Worldwide 1 This annual report includes forward-looking statements regarding Takeda's plans, prospects, strategies and accomplishments, etc. These prospects are the result of assessment obtained from information currently available, and since the actual performance could be influenced by various risks and uncertainties, it shall be noted that the course of action could differ substantially from those prospects. Factors that could affect future prospects would include, but are not limited to, economic circumstances surrounding Takeda's domain identity, competitive pressures, relevant laws and regulations, change in the status of product development, exchange rate risk and so on. Precautions Regarding Forward-Looking Statements Takeda has issued an integrated Annual and CSR Report since fiscal 2006, in order to facilitate a comprehensive underst
40 Setting Blopress on a Further Upward Trajectory Despite the difficult market circumstances, net sales of ethical drugs in the Japanese market reached 529.7 billion (a 2.9 percent increase over the previous year) and firmly maintaining the top market share in Japan. Net sales of the anti-hypertension drug: Blopress (generic name: candesartan cilexetil)our ultimate growth driverreached 137.1 billion (a 6.1 percent increase over the previous year), obtaining the top sales position among all the ethical drugs sold in Japan for the third consecutive year. In November 2007, the study results of HIJ- CREATEa large scale clinical trialwere released at the AHA: the American Heart Association's Scientific Sessions 2007 and the outcome showed that therapy based on Blopress significantly inhibits the incidence of major adverse cardiovascular events of new-onset patients with diabetes and those with impaired renal function. The implementation of HIJ-CREATE was targeted at coronary artery disease patients with hyperten
OSAKA, Japan, December 24, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will respond to the alogliptin New Drug Application (NDA) by June 26, 2009.
OSAKA, Japan, October 10, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
Osaka, Japan, September 29, 2008-Takeda Pharmaceutical Company Limited ("Takeda") announced today that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for Alogliptin (development code: SYR-322) for treatment of type 2 diabetes. Alogliptin is a dipeptidyl peptidase-IV (DPP-4) inhibitor taken once a day, and were created by Takeda San Diego, Inc., Takeda's wholly-owned subsidiary located in San Diego, California.
San Francisco, Calif., June 07, 2008 – Results from five pivotal phase 3 studies of alogliptin were announced today at the American Diabetes Association (ADA) 68th Scientific Sessions by Takeda Global Research & Development Center, Inc. Alogliptin, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4), is currently under investigation as an oral treatment for type 2 diabetes. Alogliptin administered once daily demonstrated statistically significant reductions in hemoglobin A1c(HbA1c) versus placebo as a monotherapy and as an add-on therapy with the major classes of type 2 diabetes medications: metformin, thiazolidinediones, insulin and sulfonylureas.
Osaka, Japan, January 4, 2008 --- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes. Discovered by Takeda San Diego, Inc., alogliptin was designed to selectively inhibit DPP-4 taken orally once-daily.
Osaka, Japan/Wilmington, N.C., July 14(JST) and 13(ET), 2005 --- Takeda Pharma-ceutical Company Limited ("Takeda") and PPD, Inc. (Nasdaq: PPDI) today announced an agreement in which Takeda acquired the development and marketing rights to all dipeptidyl peptidase IV (DPP4) inhibitors previously granted to PPD under an agreement between PPD and Syrrx, Inc. Takeda acquired Syrrx, Inc., now known as Takeda San Diego, Inc., in March 2005.
Takeda Pharmaceutical Company Limited (Osaka, Japan, "Takeda", President and Chief Operating Officer: Yasuchika Hasegawa) announced today that Takeda and Syrrx Inc. (San Diego, CA, "Syrrx", Chairman of the Board: Samuel D.Colella) agreed on February 5, 2005 (PST) to merge Syrrx, Inc. into the Takeda Group. The merger is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and is subject to the satisfaction of other customary closing conditions. Upon successful completion of the transaction, which is anticipated to occur in the first quarter of 2005, Syrrx will become a subsidiary of Takeda America Holdings, Inc., a wholly owned subsidiary of Takeda.