Pressure Mounts For Amylin As Bydureon PDUFA Approaches

With the unwinding of its once-lucrative nine-year partnership with Eli Lilly & Co., Amylin Pharmaceuticals Inc. now carries all the risk – and all the reward – of its exenatide franchise for diabetes. Much of how the company charts its new course will depend upon the successful approval and launch of a successor to its flagship exenatide formulation Byetta. The FDA action date for that long-awaited, long-acting version of exenatide, Bydureon, is now approaching on Jan. 28.