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.
The manufacturing discontinuation was a business decision made by the Company.
Prior to starting Xyosted, the patient’s baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
The year-long Phase 2b trial, funded by the National Institutes of Health, will enroll approximately 420 couples that are seeking pregnancy prevention across 3 US sites (Los Angeles, Seattle, and Kansas City).
