Pfizer and Opko Health reported their Phase III clinical trial of somatrogan met the primary endpoint compared to Genotropin (somatropin) for treating children 3 to 18 years of age with growth hormone deficiency (GHD).
Ascendis Pharma, based in Copenhagen, Denmark, announced that the company’s once-weekly TransCon Growth Hormone hit the primary endpoints in a Phase III height study in children with pediatric growth hormone deficiency.
Ferring Pharmaceuticals Inc. announced that the U.S. FDA approved Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
Versartis Inc. said the company’s experimental human growth hormone somavaratan failed to meet endpoints in a critical Phase III trial.
OPKO Health Inc. said its experimental drug for GHD in adults failed to provide a statistically significant benefit over a placebo in a late-stage study.