Senator Herb Kohl (D), chair of the Special Committee on Aging, sent letters to AstraZeneca, GlaxoSmithKline, Eli Lilly, Novartis, Pfizer, and Sanofi-Aventis asking them to explain why Americans on average pay twice as much as people in other industrialized countries for prescription drugs… Read more
Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM).
In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. The companies view this response as a positive step forward… Read more
The Food and Drug Administration (FDA) announced that following the closure of FDA building due to extreme weather it was granting a five day extension for the review of Amylin Pharmaceuticals Inc and Eli Lilly and Co’s Exenatide Once Weekly New Drug Application. The new drug is part of a collaboration between the companies started in 2002, which includes the currently available twice daily type 2 diabetes drug… Read more
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to Byetta (exenatide injection taken twice daily), in patients with type 2 diabetes… Read more
Eli Lilly and Company announced the availability of a smaller vial of insulin containing 3 mL (300 units), the first such vial in the United States. A typical vial of insulin contains 10 mL, or 1,000 “units” of insulin.
Lilly developed this new smaller vial for use in hospitals based on feedback regarding the average duration of patient hospital stays. Read more
Chicago Bears quarterback Jay Cutler visited the University of Chicago’s Kovler Diabetes Center on World Diabetes Day.
Cutler met with teenage diabetics to discuss his experience with diabetes. The quarterback recently recorded six videos that detail his experience with diabetes, its impact on his life and sports career, and how he manages the disease as a professional athlete… Read more