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Takeda Pharmaceutical Company Limited
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R&D News
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TAKEDA ANNOUNCES GEMINI II TRIAL OF VEDOLIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE MET PRIMARY ENDPOINTS OF IMPROVEMENT IN CLINICAL REMISSION IN INDUCTION AND MAINTENANCE PHASESPatients in the trial had failed at least one conventional therapy
OSAKA, Japan, May 11, 2012--- Takeda Pharmaceutical Company Limited (TSE:4502) today announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal phase 3 trial. The trial evaluated vedolizumab in 1,115 patients with moderately to severely active Crohn’s disease who have failed at least one conventional therapy, including TNFα antagonists. Many of the patients included in the study had failed two or more TNFα antagonists. Patients received a year of vedolizumab (MLN0002) or placebo treatment, starting with six weeks of induction therapy. In both phases of the trial, induction and maintenance, vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo. Additionally, vedolizumab provided a numerically higher rate of enhanced response, the other primary end point in the induction phase, although not statistically significant.
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Takeda Receives Complete Response Letter from the FDA for Type 2 Diabetes Investigational Therapies Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone
Deerfield, Ill., April 25, 2012, and Osaka, Japan, April 26, 2012 – Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. today announced that the company received a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone.
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Takeda and AMAG Receive A Positive CHMP Opinion in Europe for Rienso® (ferumoxytol) for the Treatment of Iron Deficiency Anaemia in Adult Chronic Kidney Disease Patients
London, UK, April 20, Osaka, Japan, April 23 and Lexington, MA, USA April 20 – Takeda Pharmaceutical Company Limited (Takeda) and AMAG Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for ferumoxytol, a new intravenous (IV) iron therapy with a proposed indication for the treatment of iron deficiency anaemia (IDA) in adult patients with chronic kidney disease (CKD).
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Open-Source Drug Research Consortium Draws a Major New Champion• Six World Leading Drug Makers Contribute $50 Million for Early-Stage Research• New Approach Speeds Drug Development by Sharing Risks
TORONTO, Canada and OSAKA, Japan (April 4, 2012) – Takeda Pharmaceutical Company Limited (Takeda) has joined the Structural Genomics Consortium (SGC) to fund collective drug research aimed at bringing new, more effective medicines to market faster. The SGC is based at the Universities of Toronto, Canada, and Oxford, England.
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AFFYMAX AND TAKEDA ANNOUNCE FDA APPROVAL OF OMONTYS® (PEGINESATIDE) INJECTION FOR THE TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE (CKD) IN ADULT PATIENTS ON DIALYSIS-- Only Once-Monthly ESA Treatment For Dialysis Patients To Be Made Available In The United States --
Palo Alto, Calif. – March 27, 2012, and Osaka, Japan – March 28, 2012 - Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) approved OMONTYS® (peginesatide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the United States.
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