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...
Category: Injectable Medication
New Patient Reported Outcomes (PRO) data presented by today at the European Association for the Study of Diabetes (EASD) congress in Stockholm challenge the widespread perception that patients prefer oral to injected glucose-lowering therapies.
Results from the 26-week, open-label study show that patients taking injectable Victoza (liraglutide 1.8 mg) reported significantly higher overall treatment satisfaction after 26 weeks than...
Sanofi-aventis announced the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes. These results were presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden...
Health Canada is informing Canadians that Novo Nordisk Canada Inc. has agreed to voluntarily recall two lots (YW60335 and YW60351) of their product, GlucaGen Hypokit (DIN 02333627) currently available on the Canadian market...
Incretin-based treatments target the beta cell and enhance the release of insulin based on the amount of glucose in the blood...
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...
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...
Amylin Pharmaceuticals, Inc. announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular (CV) events associated with SYMLIN(R) (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin...
Late-breaking Novo Nordisk extension data presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose (FPG) than Januvia plus metformin at 52 weeks...
Novo Nordisk today announced the decision to re-initiate the global phase 3 development program of liraglutide for the treatment of obesity.
Following the US approval of Victoza for the treatment of type 2 diabetes, Novo Nordisk has been in dialogue with the FDA regarding the further progression of the development program investigating...