The U.S. FDA said it has revoked the emergency use authorization for the DPP test system for the Zika virus by Chembio Diagnostic Systems Inc., of Medford, N.Y. This EUA had been amended twice since institution in 2017, but the sponsor has submitted a regulatory filing for 510(k) clearance, citing a predicate described as Zika virus serological reagents.
The International Trade Commission announced it has received a complaint filed by Novartis Pharma AG, of Basel, Switzerland, and its U.S. subsidiaries alleging patent infringement in connection with pre-filled syringes imported into the U.S. by Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. The alleged infringement is of claims 1-6 and 11-26 of U.S. patent no. 9,220,631, which describes syringes filled with pharmaceutical agents approved for treatment of ophthalmic disease. The Regeneron Eylea (aflibercept for injection) is the pharmaceutical contained in the purportedly infringing article, while the Novartis product in question is Lucentis (ranibizumab).