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May 29, 2014
07:06 EDTINSYInsys Therapeutics submits Type II DMF to FDA for CBD API
Insys Therapeutics announced it has submitted a Type II Drug Master File, or DMF, to the FDA for its cannabidiol, or CBD, active pharmaceutical ingredient, or API, and has been issued DMF# 28255. Insys recently announced plans to advance development of its pharmaceutical CBD program for the treatment of epilepsy in children and adults.
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August 25, 2014
09:11 EDTINSYOn The Fly: Pre-market Movers
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07:07 EDTINSYInsys Therapeutics receives FDA orphan drug designation for CBD
Insys Therapeutics announced that the FDA has granted orphan drug designation to its pharmaceutical cannabidiol, or CBD, for the treatment of glioblastoma multiforme, or GBM, the most common and most aggressive malignant primary brain tumor in humans. In addition to receiving orphan drug designation, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute, or CPMCRI, based in San Francisco to license CPMCRI's patent rights related to the usage of cannabinoids for the treatment of GBM.

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