Lilly and Alkermes submit answer FDA complete response letter for BYDUREON Amylin Pharmaceuticals.

Amylin, Lilly and Alkermes submit answer FDA complete response letter for BYDUREON Amylin Pharmaceuticals, Inc. , Eli Lilly and Firm and Alkermes, Inc. today announced that the firms have submitted their reply to a full response letter released in October 2010 by the U.S. The firms expect to receive an up to date Prescription Drug User Fee Action action day from the FDA next two weeks. Because the reply included additional data, it will likely be categorized as a Class 2 resubmission requiring up to half a year for review. Additionally, it includes an update of protection information from studies ongoing or completed since the last submission, as is standard practice in a complete response scenario.Kaiser Family Foundation. Copyright 2007 Advisory Board Firm and Kaiser Family Foundation. All rights reserved.

Cognoptix provides upgrade on multi-site clinical trial of SAPPHIRE II eye test Cognoptix announced today that it has reached the halfway point in a multi-site clinical trial of its SAPPHIRE II attention test designed to identify Alzheimer's disease patients with a beta amyloid signature to them. By detecting a specific fluorescent signature of ligand-marked beta-amyloid in the supranucleus area of the human lens, SAPPHIRE II attained a two-fold differentiation factor between a group of five healthful volunteers and several five patients identified as having probable Alzheimer's disease in a recently available proof-of-concept clinical trial.