Company News: FDA, Genentech and MannKind

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The FDA approved Actemra, a novel biologic from Roche Holdings's Genentech unit, for treating rheumatoid arthritis in patients who have failed other therapies. The drug will compete with Johnson & Johnson's Remicade and Abbott Labs' Humira, both of which are designed to inhibit tumor necrosis factor. Actemra is designed to block interleukin-6.

MannKind said the FDA will not be able to review an NDA for its inhaled-insulin therapy by the scheduled action date of Jan. 16, as the agency has not finished inspecting the manufacturing facilities of MannKind's third party insulin supplier. The agency did not ask for any new trials or other action prior to making its decision on the device, although it still could, and MannKind is still awaiting a new PDUFA date. FDA also accepted the trade name Afrezza for the product, which was formerly known as Afresa.
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