An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Positive Long-Term Results from Phase 2 HELIOS Clinical Trial of AMX0035 in People with Wolfram Syndrome On May 12, Amylyx Pharmaceuticals, Inc. announced positive Week 48 data from the Phase 2 open-label HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * New OTC Weight Loss Pill Granted Patent On May 6, Olfactive Biosolutions was granted a patent for formulations of food molecules that cause significant weight loss when taken as a daily pill. The company’s Pivit supplement induces the simultaneous secretion of...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * First Participant Dosed in Pivotal Phase 3 LUCIDITY Trial of Avexitide in Post-Bariatric Hypoglycemia On April 30, Amylyx Pharmaceuticals, Inc. announced that the first participant has been dosed in the pivotal Phase 3 LUCIDITY clinical trial of avexitide, an investigational, first-in-class glucagon-like...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * FDA Grants Isturisa® (Osilodrostat) Expanded Indication for the Treatment of Enodogenous Hypercortisolemia in Patients with Cushing’s Syndrome On April 15, Recordati announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ISTURISA® (osilodrostat) for...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * CABOMETYX® Receives FDA Approval to Treat Neuroendocrine Tumors On March 26, Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Celltrion Receives U.S. FDA Approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) Biosimilars Referencing PROLIA® and XGEVA® On March 3, Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * FDA Approves New Treatment Option For A Leading Cause of Diabetes-Related Blindness Genentech, a member of the Roche Group on February 4 announced that the U.S. Food and Drug Administration (FDA) approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of...
An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. * Olfactive Biosolutions Granted Third Dual GLP-1 / GIP Patent to Repurpose Food Molecules for Weight Management and Blood Sugar Regulation Olfactive Biosolutions was recently granted a third patent for inducing the secretion of GLP-1 and GIP, in U.S. patent US 12,171,727...
