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Friday, July 12, 2019

Janssen files U.S. application for subcutaneous Darzalex

Genmab A/S (OTCPK:GNMSFannounces that licensee Janssen Biotech, a unit of Johnson & Johnson (JNJ -5.2%), has filed a marketing application with the FDA seeking approval for a subcutaneously administered formulation of multiple myeloma med Darzalex (daratumumab).
The FDA first OK’d the intravenous formulation in November 2015.
JNJ is down on reports that the U.S. Department of Justice is pursuing a criminal probe related to its communications to the public about its talcum powder products.
Related ticker: Halozyme (HALO -0.9%) (ENHANZE drug delivery technology enables subcutaneous administration of biologics. Janssen in-licensed it in December 2014).

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