Drugs

Positive Hypoparathyroidism Trial Data: AstraZeneca

AstraZeneca says recent data from the CALYPSO Phase 3 hypoparathyroidism trial showed that eneboparatide, an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with “statistical significance.” The company says the trial is evaluating the therapy’s use in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared to placebo. The primary endpoint is a composite of albumin-adjusted serum calcium level normalization and independence from active vitamin D and oral calcium therapy, it says

HypoPT is a rare endocrine disease caused by a deficiency of PTH that leads to impaired regulation of calcium and phosphate levels in the blood, according to AstraZeneca, adding that this can lead to clinical manifestations, including negative impacts on the kidneys and bones.

During the trial, eneboparatide was well tolerated, AstraZeneca says. Full efficacy and safety data will be analyzed at 52 weeks, it says, and data will be shared with global regulators.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome