Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule. Oramed was founded by a … Read more
JDRF announced today its new executive vice president of research and advocacy, David E. Wheadon, M.D. Dr. Wheadon brings 26 years of experience as a highly effective leader in drug development and translational research, regulatory and medical affairs, and patient advocacy. Read more
Insulet Corporation, the company behind the OmniPod tubeless Insulin Management System, announced it has entered into an agreement with Eli Lilly and Company according to which Insulet will develop a new version of the OmniPod insulin pump specifically designed to deliver Eli Lilly’s Humulin R U-500 insulin, Read more
The FDA has approved Janssen Pharmaceutical’s new type 2 diabetes treatment, Invokana (canagliflozin). Invokana is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States. Read more
Johnson & Johnson’s LifeScan, Inc. is initiating a voluntary recall and replacement for all of its OneTouch VerioIQ blood glucose meters in the United States, effective immediately.
LifeScan is recalling and replacing all OneTouch VerioIQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment. Read more
The FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. Read more
The ADA has released new research estimating the total costs of diagnosed diabetes have risen to $245 billion in 2012 from $174 billion in 2007, when the cost was last examined. This figure represents a 41 percent increase over a five year period. Read more
The U.S. FDA cleared Tandem’s t:connect Diabetes Management Application, the web-based data management companion to the t:slim Insulin Pump.
The t:connect Application is a Mac and PC-compatible data management software application that provides t:slim pump users and their healthcare providers a fast, easy, and visual way to display data from the pump and supported blood glucose meters. Read more
The FDA has accepted Sanofi’s New Drug Application (NDA) for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes, for review. The acceptance of the lixisenatide NDA filing follows the February 1, 2013, European Commission approval of lixisenatide in the European Union. Read more
The U.S. FDA issued a Complete Response Letter regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) informing Novo Nordisk that an application cannot be approved in its current form. Read more
