Steve Duffy

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Most Recent Articles by Steve Duffy

Hypoparathyroidism Treatment Granted Orphan Drug Designation

Hypoparathyroidism Treatment Granted Orphan Drug Designation

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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.

LDL-C Reduction Examined With Different Evolocumab Dosing Regimens

LDL-C Reduction Examined With Different Evolocumab Dosing Regimens

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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.

Oral T1D Treatment Zynquista to Be Reviewed by FDA

Oral T1D Treatment Zynquista to Be Reviewed by FDA

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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.

Osteoporosis Drug Shows Cardioprotective Potential at 10-Year Follow-Up

Osteoporosis Drug Shows Cardioprotective Potential at 10-Year Follow-Up

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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).

White House Unveils Plan to Lower Cost of Prescription Drugs

White House Unveils Plan to Lower Cost of Prescription Drugs

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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."

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