Amgen's Parasabiv Rejected by FDA
News Aug 26, 2016
Amgen has announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
The correspondence of a Complete Response Letter means that the FDA has decided that they will not approve Parsabiv in its present form.
Amgen is reviewing the Complete Response Letter, and anticipate a post-action meeting with the FDA later this year to discuss the Complete Response.
Amgen claim that the Complete Response Letter does not impact their regulatory submissions in other regions.
Insulin Goes Viral: Diabetes and Cancer-causing Mechanisms ExploredNews
Every cell in your body responds to the hormone insulin, and if that process starts to fail, you get diabetes. In an unexpected finding, scientists have identified four viruses that can produce insulin-like hormones that are active on human cells. The discovery brings new possibilities for revealing biological mechanisms that may cause diabetes or cancer.READ MORE