News

Ascendis Seeks EMA Approval of TransCon PTH for Adults in EU

Ascendis Pharma is seeking approval of its treatment candidate TransCon PTH for adults with hypoparathyroidism in the European Union, the company has announced. The request, submitted as a marketing authorization application (MAA) to the European Medicines Agency (EMA), follows a similar application submitted in September to the U.S.

Survey Assesses Expert Practices for Monitoring Hypoparathyroidism

Most experts report similar practices for how they monitor blood and urine tests in people with chronic hypoparathyroidism, but monitoring practices for disease complications like kidney or bone problems are more variable, a new study reports. “While [blood] and urine measurements are completed consistent with published guidelines and consensus…

Trial Testing MBX 2109 in Healthy Volunteers Advances to Part 2

A Phase 1 clinical trial evaluating the safety and pharmacological properties of MBX 2109 — MBX Biosciences’ investigational hormone replacement therapy for people with hypoparathyroidism — in healthy volunteers has moved to its second part. This portion, which will test multiple MBX 2109 doses, follows the successful completion…

Hypoparathyroidism After Thyroid Removal Found to Surpass Estimates

Persistent hypoparathyroidism after complete removal of the thyroid gland is more common than previously thought, a study in Japan has found. These findings, based on health insurance claims, add to previous reports linking persistent hypoparathyroidism after the surgery (called a total thyroidectomy) with greater risk for renal insufficiency and…

Amolyt’s AZP-3601 Safely Normalizes Calcium Levels in Trial

Treatment with AZP-3601, Amolyt Pharma’s experimental therapy for hypoparathyroidism, safely brought calcium levels to within normal ranges in the first group of patients in a Phase 2 clinical trial, the company has announced. Most of the trial participants were able to discontinue standard treatment with calcium and vitamin…

Ascendis Seeks FDA Approval of TransCon PTH for Adults

Ascendis Pharma has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of its treatment candidate TransCon PTH for adults with hypoparathyroidism, the company announced. “Our data support that TransCon PTH, if approved, could become the first-in-class therapy to address the underlying cause of…