Injectable Medication | Page 9 of 10

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...

Novo Nordisk to Launch Victoza in Japan

Novo Nordisk announced that it has received approval for the price of Victoza, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare. The price approval allows Novo Nordisk to commercially launch in Japan shortly after Victoza is officially posted on Japan’s National Health Insurance price list on June 11th...

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...

Novo Nordisk Anounces Victoza Cardiovascular Outcomes Trial

Novo Nordisk (NVO) announced today details of the company's cardiovascular outcomes trial for Victoza® (liraglutide [rDNA origin] injection), which is set to start in the autumn of 2010. The trial named LEADE aims to assess and confirm the cardiovascular safety of the company's new once-daily human GLP-1 analog Victoza...

Superior Efficacy of Victoza Compared to Januvia in the Treatment of Type 2 Diabetes

Novo Nordisk's new diabetes drug Victoza proved more effective than Merck & Co's Januvia in a head-to-head study published, in the Lancet. The 26-week trial showed that Victoza produced significantly greater reductions in HbA1C, fasting plasma glucose and body weight than Januvia, with similar or better overall treatment satisfaction....

Sanofi-Aventis Diabetes Monotherapy Meets Phase III Study Endpoint Successfully

Sanofi-aventis announced the results of the first placebo-controlled study of the GetGoal Phase III clinical trial program of lixisenatide (AVE0010), a once-daily GLP-1 agonist developed for patients with type 2 diabetes. The 12-week study involved 361 patients with type 2 diabetes not currently receiving glucose-lowering therapy and with HbA1c between 7 and 10%...

Victoza Improves Blood Sugar Control in Patients with Type 2 Diabetes

According to a Novo Nordisk announcement the results from their LEAD™ 6 extension study show that switching to once-daily Victoza® (Liraglutide [rDNA Origin] Injection) from exenatide improves blood sugar control in patients with type 2 diabetes. The study published online in Diabetes Care evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza...

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...

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...

Roche drug may offer valuable new treatment option for patients with type 2 diabetes

Roche announced today that results from the first five Phase III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose in these studies. Roche’s taspoglutide, the first weekly human GLP-1 analogue in late stage development may improve treatment options for patients with type 2 diabetes...