Category: Injectable Medication

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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...
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Amylin’s Type 2 Diabetes Drug, BYDUREON, Fails to Meet Primary End Point in New Study

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced the top-line results from the DURATION-6 study comparing once weekly BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, to Novo Nordisk's daily Victoza (liraglutide (rDNA origin) injection). Both drugs are members of the class of type 2 diabetes medications known as glucagon-like peptide-1 (GLP-1) receptor agonists...
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Positive Results for New Sanofi-aventis Type 2 Diabetes Drug

Sanofi-aventis announced that the GetGoal-X Phase 3 study of lixisenatide, a once-daily GLP-1 receptor agonist, has achieved primary efficacy endpoint. Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus.
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Amylin Submits Initial Sections of Rolling Biologics License Application for Metreleptin

Amylin Pharmaceuticals, Inc. announced that it has submitted the initial sections of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of lipodystrophy. Consistent with the severity and rare nature of the disorder...
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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...
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Amylin Pharmaceuticals and JDRF to Collaborate on Study of Metreleptin as Diabetes Therapy

The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. have agreed to to provide financial support for a clinical proof-of-concept study to investigate the effects of metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes which will be conducted at The University of Texas (UT) Southwestern Medical Center...
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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...
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