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Bausch + Lomb And Nicox Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene Bunod
March 20, 2017
LAVAL, Quebec and SOPHIA ANTIPOLIS, France, March 20, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (Euronext Paris: FR0013018124, COX) today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of August 24, 2017 for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
If approved, latanoprostene bunod would be the first nitric-oxide donating prostaglandin F2α analog for ophthalmic use.
"This is an exciting development in our journey to bring this new treatment option to the more than 3 million1 patients in the U.S. with open angle glaucoma and ocular hypertension, and address a significant unmet medical need," said Joseph C. Papa, Chairman and CEO of Valeant. "Valeant is committed to delivering therapies that make a difference in patients' lives, and our work on latanoprostene bunod is a strong example of that."[...]