If at first Bydureon don't succeed, then try try again. Well, the last time Amylin, Alkermes and Lilly submitted their package to the FDA to gain approval for Bydureon -- as a oonce-weekly version of Byetta -- it was not accepted. The FDA wanted more studies to determine whether the drug caused heart problems.
The companies announced recently that a new study failed to find an issue with heart rhythms. Now they plan to resubmit their application (for the third time!) to gain the agency's approval. Here's betting that a third time will be a charm. See Fierce Biotech.
Posted by Bruce Lehr July 29th 2011.