Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient.
Incretins are not just metabolic hormones that regulate glucose levels after eating. Their functions go beyond stimulating the release of insulin from the pancreas. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), the two main incretins, have receptors and effects in different organs, including the heart, brain, bone and kidneys. Even if they do not directly play those keys, other organs such as the liver and muscle receive signals from the same score and join the orchestra.
Friday the 13th could be a make-or-break day in the U.S. for Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid). That’s the day the company will make its case before the FDA’s Gastrointestinal Drugs Advisory Committee for turning an 8-year-old accelerated approval into traditional approval.
New miR-124 activators have been reported in a recent Nanjing Synnocare Pharmaceutical Technology Co. Ltd. patent as potentially useful for the treatment of Alzheimer type dementia, Parkinson’s disease, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, cancer and viral infections.
A Scandiedge Therapeutics AB patent details compounds targeting pyruvate kinase PKLR reported to be useful for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma.
Regeneron Pharmaceuticals Inc. has patented new 17-β-hydroxysteroid dehydrogenase 13 (HSD17B13; 17-β-HSD-13) inhibitors reported to be useful for the treatment of liver diseases.
Researchers from Southern Medical University have divulged the discovery and preclinical characterization of novel PDE4 inhibitors for the treatment of hepatic sepsis. Synthesis and optimization of a series of 7-alkoxybenzofurans led to the identification of compound [I] as the lead PDE4 inhibitor, with PDE4B and PDE4D IC50 values of 10.0 and 15.2 nM, respectively.
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