An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Sandoz Receives FDA Approval for Denosumab Biosimilars On March 5, Sandoz announced that the U.S. Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. Keren Haruvi,...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Exact Sciences Launches Riskguard™ Hereditary Cancer Test in the U.S. On February 27, Exact Sciences Corp., announced the launch of the Riskguard™ hereditary cancer test in the United States. The Riskguard test provides an individualized patient report that includes gene specific...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Medicare Coverage Significantly Expanded for the Eversense E3 CGM System On February 12, Ascensia Diabetes Care, announced that Medicare has significantly expanded access to the Eversense E3 CGM System with the implementation of Local Coverage Determinations providing access to implantable CGM...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Spruce Biosciences Completes Enrollment in CAHmelia-204 Study for Adult Classic Congenital Adrenal Hyperplasia Last month, Spruce Biosciences, announced completion of enrollment in its CAHmelia-204 clinical trial of tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH). Spruce Biosciences is...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Pilot Study Announced Exploring the Effect of Oral Testosterone Therapy (CIII testosterone undecanoate capsules) on Male Fertility On January 9, Marius Pharmaceuticals, announced it has initiated a pilot study to better understand the effect of oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate), on spermatogenesis...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Baseline Characteristics Reported from CAHmelia-203 and CAHmelia-204 Studies in Adult Classic CAH Spruce Biosciences, Inc., today reported baseline characteristics of patients enrolled in the CAHmelia-203 and CAHmelia-204 clinical studies of tildacerfont for the treatment of adult classic congenital adrenal hyperplasia (CAH)....
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency On December 19, Ascendis Pharma announced positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * FDA Approves Lilly’s Zepbound™ (tirzepatide) for Chronic Weight Management On November 8, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide)...
