Janssen announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of end-stage renal disease and renal or cardiovascular (CV) death in adults with type 2 diabetes and chronic kidney disease.
The American Diabetes Association (ADA) has updated the Standards of Medical Care in Diabetes for 2019 based on recently published research.
The Food and Drug Administration (FDA) has approved Jatenzo (testosterone undecanoate; Clarus Therapeutics) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Tandem Diabetes Care announced that the Food and Drug Administration (FDA) has authorized the t:slim X2 insulin pump with interoperable technology, the first of the Alternate Controller Enabled Infusion Pumps.
Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters.
The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness.
Amgen announced that all Repatha (evolocumab) devices are now available at a 60% reduced list price. This includes the pre-filled syringe, the SureClick autoinjector, and the Pushtronex device, an on-body infusor with prefilled cartridge.
Fresenius Kabi announced the availability of Omegaven (fish oil triglycerides) injectable emulsion as a source of calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis.
The data showed a <0.1% risk of statin-induced muscle injury, including rhabdomyolysis, and a ~0.001% risk of serious hepatotoxicity. Statin-induced newly diagnosed diabetes mellitus was a ~0.2% risk per year of treatment, depending on baseline risk in the patients studied.
Currently, same-day delivery is available only in Dallas, Chicago, New York City, Gainesville, Miami, Tampa, and Fort Lauderdale; this program will be expanded in 2019.
