Novel Combined Oral Contraceptive Effective in Phase 3 Trial
Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters.
All articles by Da Hee Han, PharmD
Osphena Approved for Moderate to Severe Vaginal Dryness Due to Menopause
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.
All Repatha Devices Launched at Reduced List Price
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.
Omegaven Available for Pediatric Parenteral Nutrition-Associated Cholestasis
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.
AHA: Statin Benefits Outweigh Risks
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.
Walgreens Now Offers Next-Day Rx Delivery Service With FedEx
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.
Hypothyroidism Treatment No Longer Available
The manufacturing discontinuation was a business decision made by the Company.
Xyosted Now Available for Treatment of Testosterone Deficiency
Prior to starting Xyosted, the patient’s baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
Male Contraceptive Gel to Be Evaluated in Clinical Trial
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).
Icosapent Ethyl Reduces Ischemic Event Risk in Patients With Hypertriglyceridemia Despite Statin Use
The risk for the primary composite endpoint was significantly lowered by 25% among patients who received 2g of icosapent ethyl twice daily vs those who received placebo.
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