FDA Accepts Sanofi’s NDA for New Basal Insulin, Toujeo

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The U.S. Food and Drug Administration (FDA) has accepted for review Sanofi’s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014. Read more

FDA Approves Afrezza Rapid-Acting Inhaled Insulin

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The U.S. FDA approved Mannkind Corporation’s Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin, to improve glycemic control in adults with diabetes mellitus. Afrezza is administered at the beginning of each meal, or within 20 minutes after starting a meal. Read more

In Europe, Medtronic Launches The MiniMed Duo, First Combined Glucose Sensor and Insulin Infusion Set

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Medtronic has announced the European launch of MiniMed Duo, the world’s first two-in-one glucose sensor and insulin infusion set, simplifying integrated insulin pump therapy and continuous glucose monitoring (CGM). MiniMed Duo, which is used with the MiniMed Veo system (the European version of the Minimed 530G), makes it easier for more people with diabetes to benefit from CGM. Read more

Lilly’s New Basal Insulin Peglispro Proves Equal to Lantus in Phase 3 Clinical Trial

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Eli Lilly and Company have announced positive top-line results of three completed Phase III clinical trials in patients with type 2 diabetes for basal insulin peglispro (BIL). Peglispro is being studied as a once-daily treatment for both type 1 and type 2 diabetes. The primary efficacy endpoint of non-inferior reduction in hemoglobin A1c (HbA1c) compared to insulin glargine was met in all three trials. Read more

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