Alerts

NIH Pulls Plug on (AIM-HIGH) Trial with Niacin. Trial of extended-release niacin (Niaspan, Abbott) given in addition to statin therapy in patients with a history of cardiovascular disease, high triglycerides, and low levels of HDL cholesterol has been halted prematurely, 18 months ahead of schedule, because niacin offered no additional …

  Diamyd Medical reports that results from its European Phase III study with the antigen-based therapy Diamyd® did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, as measured by meal stimulated C-peptide, in newly diagnosed Type 1 diabetes patients.

See this week’s Item #2.

Lixisenatide Success Next possible GLP-1 diabetes drug from Sanofi-Aventis (lixisenatide) has success in a late stage trial, reducing A1c and body weight without increasing risk of hypoglycemi BYDUREON™ recommended for approval in Europe. BYDUREON would be first once-weekly treatment for adults with Type 2 diabetes.

Questionable Benefit for Fibrates. See this week’s Item #2.

Amylin Pharmaceuticals and Takeda Pharmaceutical announced that they have suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of the investigational combination therapy pramlintide/metreleptin for the treatment of obesity. The clinical study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment …

  The FDA has accepted Bristol-Myers Squibb’s New Drug Application for its first in class drug dapagliflozin, an investigational selective sodium-glucose cotransporter-2 inhibitor (SGLT2), first in class compound for the treatment of adults with Type 2 diabetes.

Roche Insulin Delivery Systems recalls the ACCU-CHEK® FlexLink Plus infusion set because of the potential for under-delivery of insulin due to a kinked/bent cannula when inserting this infusion set.

FDA Denies Approval of Weight-loss Drug: The manufacturer of the drug Contrave, a combination of naltrexone plus buproion was issued a response letter from the FDA which required the manufacturers to conduct a randomized, double blind, placebo-controlled trial before the new drug application can be approved.

New Paradigm in Search for a Cure: See This Week’s Item #1.