Bydureon Receives Positive Opinion From The European Medicines Agency

Eli Lilly and Company, Amylin Pharmaceuticals and Alkermes announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Bydureon for injection in the European Union for the treatment of type 2 diabetes in combination with… Read more

Positive Results for Once Monthly Type 2 Diabetes Drug

Positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes were announced by Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. Exenatide once monthly is a new… Read more

Byetta as Safe as Other Diabetes Drugs New Study Finds

Results of a new retrospective study of nearly 375,000 type 2 diabetes patients evaluating the incidence of events related to cardiovascular disease (CVD) and all-cause hospitalizations among initiators of BYETTA(R) (exenatide) injection compared to initiators of other commonly used diabetes medications were presented by Eli Lilly and Amylin Pharmaceuticals at the American Heart Association Scientific Sessions in Chicago… 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

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

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