Avid Bioservices Inc (CDMO)

[itsabouttime]

Is this Amylin purchase by BMY & AZ related to this process?


FDA rejects AstraZeneca's diabetes combo and demands more data
October 16, 2015 | By Damian Garde

The FDA wants to see more clinical trial data on AstraZeneca's ($AZN) new combination diabetes treatment, the company said, likely delaying a potential launch by more than a year.

AstraZeneca's combo is a fixed-dose mix of saxagliptin, approved as Onglyza, and dapagliflozin, sold as Farxiga, designed to treat Type 2 diabetes. In its rejection letter, the FDA asked for additional data on the cocktail, a request that "may require information from new studies," AstraZeneca said. The company has pegged $3 billion in peak annual sales to the combination, a forecast now imperiled by regulatory delay.