Ionis Pharmaceuticals Inc. CEO Brett Monia predicted that diagnoses of familial chylomicronemia syndrome (FCS) will “accelerate fairly quickly” now that the firm has gained U.S. FDA clearance for Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with the rare form of severe hypertriglyceridemia (sHTG) that can lead to life-threatening acute pancreatitis (AP).
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome.
Bio-path Holdings Inc. has conducted preclinical studies of BP-1001-A, a drug product modification of prexigebersen, confirming its effectiveness in affecting insulin signaling for the potential treatment of obesity and related metabolic diseases in type 2 diabetes patients.
Arbor Biotechnologies Inc. has gained IND clearance from the FDA for ABO-101, a novel gene editing therapeutic designed to address primary hyperoxaluria type 1 (PH1). A phase I/II study in adult and pediatric patients with PH1 is expected to begin in the first half of 2025.
Breakthrough – or even better, revolutionary breakthrough – is perhaps the most overused term in drug development. But the discovery and development of GLP-1 receptor agonists (GLP-1RAs), which was honored with the 2024 Lasker-DeBakey Clinical Medical Research Award just last week, is one of the rare innovations that is deserving of the title.
Breakthrough – or even better, revolutionary breakthrough – is perhaps the most overused term in drug development. But the discovery and development of GLP-1 receptor agonists (GLP-1RAs), which was honored with the 2024 Lasker-DeBakey Clinical Medical Research Award just last week, is one of the rare innovations that is deserving of the title.
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide).
Researchers at Chengdu Brilliant Pharmaceutical Co. Ltd. and Scinnohub Pharmaceutical Co. Ltd. have disclosed 15-hydroxyprostaglandin dehydrogenase inhibitors reported to be useful for the treatment of diabetes, osteoporosis and more.
Scientists from the Miller School of Medicine at the University of Miami have reported their recent work to develop small-molecule inhibitors of the CD40-CD40L (CD154) costimulatory protein-protein interaction.
Merck & Co. Inc. and Hansoh Pharmaceutical Group Co. Ltd. have entered into an exclusive global license agreement for HS-10535, a preclinical oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist. Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535.
RSS
