With last week’s news that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has recommended the approval of degludec, we thought we’d give you an overview of this new drug’s pharmacology, the current approval status, trial results, and some of the cardiovascular safety concerns around degludec….
Read More »Monthly Archives: November 2012
Letter from the Editor #651
This week week the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that degludec, Novo’s new long acting insulin, be approved for use in the United States. There was a lot of the usual fuss about CV studies that seems to go along with with every new diabetes drug, but this …
Read More »C8 MediSensors
First Non-invasive CGMS system Approved in Europe. C8 MediSensors, Inc. has announced it received CE Mark approval for its Optical Glucose Monitor System, allowing the device to be marketed in Europe. See Item #5, First Possible Non-Invasive Continuous Glucose Monitor Approved in Europe, in today’s newsletter.
Read More »FDA Panel Approves Degludec
An advisory panel to the U.S. Food and Drug Administration approved Novo’s Insulin Degludec, but…. See this week’s Item #3, Novo’s Insulin Degludec Wins FDA Panel Approval.
Read More »Blindness from Diabetes Increases
According to recent studies funded by the National Eye Institute, diagnoses of diabetic retinopathy increased by 3.7 million new cases over the last decade. Approximately 7.7 million Americans are now affected by diabetic retinopathy and this is projected to climb to 11 million by 2030. People with diabetes are also …
Read More »Drink Black Tea, Prevent Diabetes?
A mathematical analysis found that the prevalence of type 2 diabetes is low in countries where people drink a lot of black tea. A multinational team of researchers compared sales information for black tea in 50 countries with data from the WHO about a variety of diseases in those same …
Read More »Eating Out Makes Kids Eat More
In a study, kids and teens ate more calories (including more fat and sugar) on days when they had a meal from a fast-food or sit-down restaurant. On two different occasions, more than 9,000 teens were asked to recall everything they’d had to eat or drink in the past 24 …
Read More »Dabigatran versus Warfarin in Diabetic Patients with Atrial Fibrillation
The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) was a randomized trial designed to compare two fixed doses of dabigatran, each administered in a blinded manner, with open-label use of warfarin in patients who had atrial fibrillation and were at increased risk for stroke….
Read More »Tight Glycemic Control Not Helpful after Kidney Transplant
For diabetic kidney recipients, early intensive glycemic control might reduce delayed graft function (DGF) but with a higher risk of rejection….
Read More »Novo’s Insulin Degludec Wins FDA Panel Approval
An FDA advisory committee voted 8-4 Thursday, November 8, in favor of approval of a new ultra-long-acting insulin Tresiba and its mixed insulin Ryzodeg for type 1 and type 2 diabetes….
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