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No new trials needed in US FDA complete response letter for once-weekly exenatide

This article was originally published in Scrip

Executive Summary

Amylin Pharmaceuticals, Lilly and Alkermes' type 2 diabetes candidate Bydureon (exenatide for extended-release injectable suspension) – a once-weekly formulation of the twice-daily dosed Byetta – has received a complete response letter from the US FDA.

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