* GelTex Pharmaceuticals Inc., of Waltham, Mass., and Genzyme Corp., of Cambridge, Mass., submitted a marketing authorization application in Europe for RenaGel, a non-absorbed phosphate binder that controls phosphate levels in patients with chronic kidney failure. RenaGel is under review in the U.S. and Canada.
* NeXstar Pharmaceuticals Inc., of Boulder, Colo., initiated the second arm of an ongoing Phase II trial of MiKasome, its liposomal formulation of amikacin, for treatment of complicated urinary tract infections. The second stage will evaluate a single dose regimen following encouraging safety and efficacy data from the first part, in which multiple doses were tested. The study's endpoints include safety, clinical and bacteriologic efficacy, and the prevention of late-onset recurrent infections.