Amylin heading back to the FDA with Bydureon app

Armed with a new batch of supporting safety data, Amylin says it will resubmit its long-delayed Bydureon--a follow-up, once-weekly version to the blockbuster Byetta--by next week. The FDA stiffed-armed Amylin and its partners Eli Lilly and Alkermes for the second time last fall, saying they wanted some assurance on potential cardiovascular risks. The companies announced recently that a new study failed to find an issue with heart rhythms. Amylin reported that its losses narrowed in the second quarter but the biopharma company's numbers fell short of analysts' estimates. Story