CK Regeon Inc. has divulged indirubin derivatives acting as CXXC-type zinc finger protein 5 (CXXC5)/DVL interaction inhibitors reported to be useful for the treatment of skin lesions, wounds, neurodegeneration, metabolic disorders and bone disorders.
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
Clearly frustrated by the U.S. FDA’s rejection of tradipitant to treat gastroparesis, Vanda Pharmaceuticals Inc. CEO Mihael Polymeropoulos said the agency is discouraging drug development for the serious gastric emptying condition for which there has been no new treatment in 40 years. The complete response letter (CRL) issued on the Sept. 18 PDUFA date for the neurokinin-1 receptor antagonist, which Vanda licensed from Eli Lilly and Co. in 2012, requested additional studies that the company said are not in line with the advice of experts in the field.
After disclosing data from the phase II Herald study, Aligos Therapeutics Inc. may sign a partner to help advance ALG-055009, a thyroid hormone receptor (THR) beta agonist, in subjects with metabolic dysfunction-associated steatohepatitis (MASH, formerly nonalcoholic steatohepatitis, or NASH).
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.
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