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News Breaks
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."
News For INSY From The Last 14 Days
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December 15, 2014
07:12 EDTINSYInsys Therapeutics price target raised to $57 from $53 at RBC Capital
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December 9, 2014
07:12 EDTINSYInsys Therapeutics receives FDA orphan drug designation for LEP-ETU
Insys Therapeutics announced that the FDA has granted orphan drug designation to its Liposome Entrapped Paclitaxel Easy to Use, or LEP-ETU, candidate for the treatment of gastric cancer. LEP-ETU is an improved formulation of paclitaxel, a widely used chemotherapeutic agent. Insys acquired LEP-ETU during its merger in 2010 with NeoPharm.
December 8, 2014
10:35 EDTINSYInsys Therapeutics management to meet with Piper Jaffray
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10:00 EDTINSYOn The Fly: Analyst Initiation Summary
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08:18 EDTINSYInsys Therapeutics initiated with a Buy at Jefferies
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December 4, 2014
11:03 EDTINSYInsys Therapeutics receives orphan status for gastric cancer treatment
The FDA said it granted Insys Therapeutics orphan status for its treatment of gastric cancer.
07:17 EDTINSYComparison study shows Insys synthetic CBD is identical to plant-based CBD
Independent comparison analyses have found that cannabidiol, or CBD, synthetically produced by Insys Therapeutics is chemically identical to plant-derived CBD. Analyses were conducted independently by Insys and the National Institute on Drug Abuse, or NIDA, part of the National Institutes of Health. The two separately-conducted analyses ascertained that Insys' synthetically produced CBD: Has identical identity and chemical structure to plant-derived CBD; Has identical stereochemistry to plant-derived CBD; both demonstrated the same CBD enantiomer with no enantiomer present, which was confirmed by Chiral Assay; Is more pure, with a 2% higher CBD Assay value than plant-derived CBD; Insys CBD total HPLC purity 99.9% vs. plant-derived CBD at 98.7%; and, Meets all ICH impurity guidelines, with no impurities greater than 0.10%, vs. plant-derived CBD which contained multiple impurities above ICH guidelines.

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