Most Recent Articles by Steve Duffy
TransCon PTH is a long-acting prodrug of parathyroid hormone designed to restore PTH to physiologic levels, normalizing blood and urinary calcium levels, serum phosphate levels and bone turnover.
For this study, researchers investigated the pharmacodynamics of evolocumab in two Phase 2 placebo-controlled studies (MENDEL and LAPLACE-TIMI 57) in order to determine which dosing regimens provided the most consistent LDL-C reduction.
The NDA was supported by data from the Phase 3 inTandem clinical trial program which assessed the safety and efficacy of Zynquista in ~3000 adults with inadequately controlled type 1 diabetes.
The 1-year cardiovascular mortality hazard ratio (HR) for alendronate users was 0.33 (95% CI, 0.17 to 0.65) and 0.55 for incident myocardial infarction (95% CI, 0.34 to 0.89).
FDA Commissioner, Scott Gottlieb MD, said, "The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs."
More Articles by Steve Duffy
Endocrinology Advisor Articles
- Efficacy and Safety of Alirocumab in Diabetes Mellitus
- Safety of DPP-IV Inhibitor, Cardiovascular Events After ACS in Type 2 Diabetes
- Sex Hormone Levels May Affect Postmenopausal Heart Disease Risk
- Effect of Fructose, Allulose on Postprandial Glucose Regulation in Type 2 Diabetes
- Transgender Youth Not Willing to Delay Hormone Therapy for Fertility Preservation
- Diabetes Treatments
- Metformin May Decrease Colorectal Cancer Risk Among Males With Diabetes
- SGLT2 Inhibitor, GLP-1 Receptor Agonist Combination Treatment for Type 2 Diabetes: Expert Insights
- Semaglutide May Induce Weight Loss in Type 2 Diabetes Despite BMI
- FDA Clears Omnipod DASH System for Diabetes Management
- Single Blood Sample Highly Predictive for Subsequent Diabetes Diagnosis
- Plasma Methylglyoxal Levels Associated With CVD, Mortality in Type 2 Diabetes
- Adjunctive Metformin for Insulin Resistance in T1D: A Clinical Perspective
- AMA: Federal Government Must Tackle Rising Insulin Prices
- Diabetes Medication Reconciliation May Reduce Risk of ED Visits