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Avandia Harms The Heart, Studies Find

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos...

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...

Novo Nordisk receives US approval for Victoza(R) (liraglutide) for treatment of type 2 diabetes

Novo Nordisk announced that it has received US FDA approval for Victoza® (liraglutide) for the treatment of type 2 diabete in adults. Victoza® is the brand name approved in the US and Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. In the US, Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes....

FDA Clears Clibra’s Insulin Patch

Calibra Medical Inc., formerly known as Seattle Medical Technologies Inc., announced today that the U.S. Food and Drug Administration has given Finesse, the company’s insulin patch-pen, 510(k) clearance. Only 2” long, 1” wide and ¼” thick, Finesse is able to hold and deliver prescribed amounts of insulin over multiple days while...

Novartis Type 2 Diabetes Drug Approved for Use in Japan

Novartis anounced that three medicines have been approved for use in Japan, among them Equa® (vildagliptin), marketed as Galvus® in the European Union, for the treatment of type 2 diabetes....

Novo Nordisk starts phase 1 trial with long-acting oral GLP-1 analogue

Novo Nordisk announced that it has initiated its first phase 1 clinical trial with a long-acting oral GLP-1 analogue (NN9924). The aim of the trial, which is conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. Results from the trial, which is planned to enroll about 155 people, are expected to be reported in 2011...

FDA Needs More Time to Review MannKind’s New Drug Application for Inhaled Insulin

MannKind Corp. announced that it was informed today by the FDA that they will not be able to complete the review of MannKind's new drug application for its ultra rapid-acting insulin therapy by the action date of January 16, 2010.The FDA explained that it has not yet completed its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind....

Biodel Inc. Submits New Drug Application to FDA for A New Form of Insulin

Biodel, Inc. announced that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for clearance to market of VIAject(R) as a treatment for diabetes. VIAjecta(R) is a formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It is Biodel's most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials...

Novo Nordisk Expects FDA Feedback on Liraglutide Within Days

Novo Nordisk today announced that formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide is expected within weeks. Liraglutide is the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes...

Is Lantus Insulin Linked to Increased Risk of Cancer? New Study Begins

Recently published studies suggested that insulin glargine (a synthetic insulin preparation marketed under the trade name Lantus), may be associated with a higher risk of certain cancers than other insulins or oral glucose lowering medications. However, these studies were unable to control for important factors such as obesity that may have driven the association...