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This case study reviews the opportunities and challenges faced by Bristol-Myers Squibb and AstraZeneca at the tail end of the development of Onglyza (saxagliptin), a treatment for type 2 diabetes. A second generation DPP-4 inhibitor, Onglyza was poised to follow on the success of Merck's Januvia when development partners BMS and AZ had to deal with a changing regulatory environment relative to safety. After its pivotal clinical trials had been launched, the FDA issued new, more stringent requirements for assessing safety of diabetes therapies, in particular for cardiovascular risk. The saxagliptin development team had to respond to these requirements as it tried to gain approval in this new regulatory climate. This study also reviews FDA's new requirements for assessing the safety of diabetes therapies in clinical testing. Executives and managers can use this research to gain insights into methods for navigating new safety concerns to win market approval in diabetes.
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