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July 2 Company Quick Takes: Gilead's Truvada REMS removed; plus UC, Amicus/Paragon and Iovance

July 2, 2019 10:28 PM UTC

FDA removes REMS for Truvada
FDA said it is eliminating the REMS for Truvada emtricitabine/tenofovir from Gilead Sciences Inc. (NASDAQ:GILD) and its four generics approved for pre-exposure prophylaxis (PrEP), which required manufacturers to provide educational materials to prescribers as part of a comprehensive HIV prevention strategy. The agency said the majority of prescribers and at-risk individuals now understand the risks of the medication and the additional HIV prevention methods required.

UC gets seventh CRISPR-Cas9 patent in U.S.
The U.S. Patent and Trademark Office issued to the University of California, the University of Vienna and Emmanuelle Charpentier their seventh issued patent in the U.S. related to CRISPR. Patent No. 10,337,029 covers methods of cleaving, modifying or targeting and binding DNA in a cell using a CRISPR protein-RNA complex, as well as methods of delivering the complex using a single guide RNA. Last week the USPTO revived a patent dispute between UC and the Broad Institute of MIT and Harvard (see "USPTO Files Independent Interference Case on CRISPR Patents")...