понедельник, 5 марта 2012 г.

Other News To Note.

* Adventrx Pharmaceuticals Inc., of San Diego, said the FDA determined in a meeting to discuss the complete response letter for lung cancer drug Exelbine (vinorelbine injectable emulsion) that while no clinical deficiencies were noted, the agency could not accept alternate methods of verifying the authenticity of the study drug, and the bioequivalence study would have to be repeated. Adventrx said it plans to seek a partner for Exelbine and focus its resources on ANX-188 (purified poloxomer 188) and ANX-514 (docetaxel for injectable emulsion). (See BioWorld Today, Aug. 11, 2011.)

* Cellceutix Corp., of Beverly, Mass., said stability trials of the drug delivery devices needed for planned clinical trials of its lead cancer compound Kevetrin are under way at FDA-approved testing facilities. A small molecule that targets p53 and other pathways, Kevetrin is being studied in drug-resistant cancers.

* Cellectis SA, of Paris, responded to a patent infringement suit filed last week by Precision Biosciences Inc., of Research Triangle Park, N.C., by responding that the patent in question u U.S. Patent No. 8,021,867 u is too narrow to cover its meganucleases and should not interfere with its ability to make, use and sell the technology. Cellectis filed a countersuit seeking a declaration that Precision's '867 patent is invalid and not infringed by Cellectis. The action follows two previous suits filed by the French …

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