FDA Requests Further Testing On Amylin’s New Type 2 Diabetes Drug

In the complete response letter regarding the New Drug Application (NDA) for Bydureon (exenatide extended-release for injectable suspension) issued Tuesday the FDA requested Amylin Pharmaceuticals, Eli Lilly and Alkermesa conduct a thorough QT study which would look at the new drug’s effect on patients’ heart rates… Read more

FDA Requests Further Testing On Amylin’s New Type 2 Diabetes Drug

In the complete response letter regarding the New Drug Application (NDA) for Bydureon (exenatide extended-release for injectable suspension) issued Tuesday the FDA requested Amylin Pharmaceuticals, Eli Lilly and Alkermesa conduct a thorough QT study which would look at the new drug’s effect on patients’ heart rates… Read more

Byetta Improves Beta-Cell Function in Type 2 Diabetics

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from a study comparing the effect of long-term treatment with either Byetta (exenatide) injection or Lantus(R) (insulin glargine) on overall beta-cell function. Three years of Byetta therapy… Read more

Byetta Helps Type 2 Diabetics Achieve Blood Glucose Control

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA(R) (exenatide) injection added to Lantus(R) (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing… Read more

New Type 2 Diabetes Drug Bydureon Shows Better Results Than Januvia

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of Bydureon (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications… Read more

FDA Classifies Bydureon Complete Response as a Class 2 Resubmission

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010… Read more

Amylin, Lilly and Alkermes Receive FDA Complete Response Letter for Exenatide Once Weekly

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

Lilly and Amylin Confirm FDA Extension of Exenatide Once Weekly New Drug Application Review

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

Novo’s Victoza Awaits Final FDA Approval

Novo Nordisk’s CEO, Lars Sorensen, told Reuters at the Reuters Health Summit in New York that the new diabetes drug Victoza has reached the final decision stage at the U.S. FDA. Sorensen expects the drug will be approved, although “potentially all the outcomes are still possible… Read more

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