The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a positive opinion for three new type 2 diabetes treatments developed by Takeda Pharmaceutical: Vipidia (alogliptin), a dipeptidyl peptidase IV (DPP-4) inhibitor, and for the fixed dose … Read more
Takeda Pharmaceutical has received FDA approval for three new treatments for type 2 diabetes – NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl).
The FDA has issued a complete response letter to Japanese drug-maker Takeda Pharmaceutical regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone… Read more
Takeda Pharmaceutical announced the launch of LIOVEL®, a fixed dose combination tablet of NESINA® (alogliptin) and ACTOS® (pioglitazone HCl) for treatment of type 2 diabetes.
LIOVEL is a tablet taken orally once daily and has two dosage strengths Read more
Takeda has resubmitted two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) for alogliptin and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone, approved in 1999, for the treatment of type 2 diabetes, in a single tablet… Read more
Takeda Pharmaceutical Company Limited has granted Teva Pharmaceutical Industries Ltd. a license to market a generic version of ACTOS® in the U.S. beginning on August 17, 2012, and a generic version of ACTOplus met® beginning December 14, 2012. The license was granted following an agreement to settle patent litigation related to Teva’s generic versions of Takeda’s ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl) in the United States… Read more
The FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. At this time, FDA has not concluded that Actos increases the risk of bladder cancer… Read more
The continuing controversy surrounding the cardiovascular risk of GlaxoSmithKline’s diabetes drug Avandia has led to sharp declines in its use and a surge in sales of the competing drug, Actos. Although the drugs are similar and both had FDA warnings in 2007, Takeda’s Actos has been… Read more
Takeda Pharmaceutical Company Limited announced today that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) Ltd. withdrew a European Marketing Authorization Application (MAA) for Competac… Read more
Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced that following positive phase 2 study results in a new obesity treatment, they will advance towards phase 3 development of a combination treatment for obesity which includes pramlintide (an analog of the natural hormone amylin) and metreleptin (an analog of the natural hormone leptin)… Read more