Insulet Issues Recall of OmniPod Insulin Management System

Insulet Issues Recall of OmniPod Insulin Management System

Insulet Corporation (Insulet or the Company) has initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods … Read more

FDA Approves Dexcom G5 Mobile Continuous Glucose Monitoring System

Dexcom

The U.S. Food and Drug Administration (FDA) has approved the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. Read more

FDA Takes Step to Remove Artificial Trans Fats from Processed Foods

FDA large logo

Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration (FDA) today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” (GRAS) for use in food. Read more

Helmsley Type 1 Diabetes Program Announces $5M Request for Proposals 

Helmsley Charitable Trust

The Type 1 Diabetes Program of The Leona M. and Harry B. Helmsley Charitable Trust has announced the launch of the Diabetes Data Innovation Initiative through which it will provide up to $5 million in funding over the next two years. The funding will go to innovative solutions that enable the use of data to ease the burden of type 1 diabetes (T1D) for those living with the disease, their caregivers and healthcare providers. Read more

New FlowSmart Infusion Set Approved by FDA

BD-logo - home

The U.S. Food and Drug Administration (FDA) approved Becton Dickinson Medical’s (BD) application to begin production of its novel FlowSmart insulin infusion set, designed to improve insulin delivery with less pain. The FlowSmart insulin infusion set was developed in collaboration with JDRF and the Helmsley Charitable Trust. Read more

Sanofi’s New Basal Insulin (Toujeo) Approved by EU

Toujeo basal insulin -Sanofi

The European Commission has granted Sanofi marketing authorization in Europe for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), for the treatment of type 1 and type 2 diabetes mellitus in adults. Toujeo is a next-generation, once-daily basal insulin based on a broadly-used molecule (insulin glargine) with a well-established benefit-risk profile. Read more

FDA Approves Toujeo, Sanofi’s New Long Acting Insulin 

sanofi-logo

The U.S. Food and Drug Administration (FDA) approved Sanofi’s new once daily long acting insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) for treatment of adults living with type 1 and type 2 diabetes.
Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR. Read more

JDRF and Janssen Team Up to Intercept Type 1 Diabetes

Janssen_logo - JnJ

Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that it will invest in a novel scientific approach, called disease interception, to find ways to intercept type 1 diabetes using new diagnostic and pre-disease intervention strategies. If successful, this approach has the potential to transform the standard of care in type 1 diabetes.
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