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Monday, July 06 2009
Takeda Global Research & Development Center, a wholly owned U.S. subsidiary of Takeda Pharmaceutical Company Limited, received on June 26 a complete response letter from the FDA, rejecting its new drug application for alogliptin, a selective dipeptidyl peptidase IV inhibitor, under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has voted in favor of the new drug application for Onglyza from Bristol-Myers Squibb (BMS) and Astrazeneca to treat adults with type 2 diabetes, stating that the data were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program.
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The FDA has extended the timeline to review Bristol-Myers Squibb and AstraZeneca's new drug application (NDA) for Onglyza for the treatment of type 2 diabetes.
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Middle age introduces itself in many ways; one is atrial fibrillation (AF). My onset of AF seems to have coincided with a mountain bike accident in the woods of North Carolina that resulted in some cracked ribs.
The use of health IT to reduce rehospitalizations will be welcome but also disruptive, said Stephen Jencks, an independent consultant in healthcare safety during a Feb. 24 webinar on the potential use of health IT to mitigate rehospitalizations, sponsored by the Agency for Healthcare Research and Quality (AHRQ).