Amid all the political and industry pontificating and finger-pointing on ever-increasing U.S. drug prices, patients are turning to the courts for relief, using a class action aimed at pharmaceutical benefit managers (PBMs) as their pulpit of choice. Read More
More than seven years after first testing its Meniere's disease candidate, Otividex, in patients with the inner ear disorder, Otonomy Inc. is immediately suspending development of the specially formulated steroid after it proved no better than a placebo in reducing both the number and severity of vertigo episodes in the first of two phase III trials. Read More
G protein-coupled receptors (GPCRs) are a very large receptor family targeted by a very large number of endogenous ligands, as well as a respectable fraction of FDA-approved drugs. Read More
The Medicines Co. (MDCO) moved Vabomere (meropenem and vaborbactam) across the goal line, garnering FDA approval to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex. Read More
Kamada Ltd., of Rehovot, Israel, said the underwriters of its public offering exercised their full option to purchase additional shares in the company, raising total gross proceeds from the offering to about $17.3 million. Cantor Fitzgerald & Co. acted as the sole book-running manager. Read More
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, submitted an application with Japanese regulators for Trerief (zonisamide) for the treatment of parkinsonism in dementia with Lewy bodies. Read More
Catalyst Pharmaceuticals Inc., of Coral Gables, Fla., reached an agreement with the FDA for a special protocol assessment for its phase III trial testing Firdapse (amifampridine) for the treatment of patients with MuSK antibody-positive myasthenia gravis, which will begin in 2018. Catalyst is also developing Firdapse for Lambert-Eaton myasthenic syndrome (LEMS), for which it received a refuse-to-file letter last year. Read More
