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FDA Grants Orphan Drug Designation for Potential Treatment of Hypoparathyroidism

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AZP-3601, Amolyt Pharma’s clinical candidate for the treatment of hypoparathyroidism. “We believe the FDA’s granting of Orphan Drug Designation to AZP-3601 reflects the agency’s recognition that new and more effective treatment options are needed for this serious endocrine disorder,” says Endocrine...
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Phase III Trials Set After Potential Type 1 Diabetes Vaccine Shows Promise

[Editor’s note: This post has been updated to clarify that the meta-analysis published in Diabetologia and the Phase IIb trial were separate studies.] Earlier this fall, Phase IIb topline results of the DIAGNODE-2 trial demonstrated a potential type 1 diabetes vaccine GAD-alum —  an immunomodulating antigen-specific therapy – had a highly significant and clinically relevant...
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Pharmaceutical Companies Team Up to Develop Acromegaly Treatment

Two pharmaceutical companies will collaborate to optimize and evaluate growth hormone receptor antagonists to select a candidate for clinical development as a potential treatment for acromegaly Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and metabolic diseases, and PeptiDream Inc., a public Kanagawa-based biopharmaceutical company, today announced a research collaboration...
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Researchers Develop First-in-Class Humanized Antibody Targeting Bone and Fat

A treatment for obesity and osteoporosis could be on the horizon as Mount Sinai researchers have developed a first-in-class humanized antibody to the follicle-stimulating hormone (FSH) that will reduce body fat, increase bone mass, enhance metabolism, and lower cholesterol. The antibody has the potential to prevent and treat obesity, osteoporosis, and hypercholesterolemia — diseases that...
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Cause & Effect: Patients with Obesity and Thyroid Function Testing

According to a new guideline from the European Society of Endocrinology, patients with obesity should be routinely tested for thyroid function. However, testing for other endocrine-related conditions should be guided by the presence of symptoms. The endocrine system and obesity can have a push-pull relationship. Some endocrine disorders — such as hypothyroidism and Cushing’s syndrome...