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June 25, 2014
07:07 EDTINSYInsys receives FDA orphan drug designation for pharmaceutical cannabidiol
Insys Therapeutics announced that the U.S. Food and Drug Administration has granted orphan drug designation to its pharmaceutical cannabidiol for the treatment of Lennox-Gastaut Syndrome, a rare pediatric-onset epilepsy. The company said, "We have the unique opportunity to test a controlled pharmaceutical CBD product for Lennox-Gastaut Syndrome, and our company is committed to advancing cannabinoid therapies that have the potential to provide significant medical benefits to patients across multiple indications. We expect to file an Investigational New Drug Application for CBD in 2H14."
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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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