Key Developments: INSYS Therapeutics Inc (INSY.OQ)

INSY.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Insys Therapeutics submits NDA for dronabinol oral solution
Tuesday, 2 Jun 2015 07:00am EDT 

Insys Therapeutics:Submits nda for dronabinol oral solution.Says expects the current nda contains all information required to permit a substantive review by the FDA.  Full Article

Insys Therapeutics Inc announces its pharmaceutical cannabidiol received fast track designation from FDA
Thursday, 26 Feb 2015 07:00am EST 

Insys Therapeutics Inc:Says U.S. Food and Drug Administration has granted fast track designation to its pharmaceutical cannabidiol formulation for treatment of dravet syndrome, a rare form of childhood epilepsy.Says drug development program with fast track designation is afforded greater access to FDA for purpose of expediting the drug's development, review and potential approval to get important new drugs to patient earlier.  Full Article

Insys Therapeutics Inc enters into exclusive sub-license agreement with Gold Coast Therapeutics
Tuesday, 24 Feb 2015 07:00am EST 

Insys Therapeutics Inc:Enters into exclusive sub-license agreement with Gold Coast Therapeutics to develop a unique combination of cromolyn sodium and cetirizine as a new chemical entity for the treatment of chronic prostatitis/chronic pelvic pain syndrome, or CP/CPPS.  Full Article

Insys Therapeutics receives FDA orphan drug designation for Liposomal Encapsulated Paclitaxel for the Treatment of Ovarian Cancer
Monday, 26 Jan 2015 08:00am EST 

Insys Therapeutics Inc:Says U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer.  Full Article

Insys Therapeutics Inc receives FDA Orphan Drug Designation for Liposome Entrapped Paclitaxel
Tuesday, 9 Dec 2014 07:00am EST 

Insys Therapeutics Inc:Says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) candidate for the treatment of gastric cancer.LEP-ETU is an improved formulation of paclitaxel, a widely used chemotherapeutic agent.  Full Article

Insys Therapeutics Inc receives FDA orphan drug designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Pediatric Schizophrenia
Monday, 24 Nov 2014 07:00am EST 

Insys Therapeutics Inc:Says the USFDA has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) candidate for the treatment of pediatric schizophrenia.Says it continues to evaluate the potential use of pharmaceutical CBD in several additional indications, including adult epilepsy, chemotherapy-induced peripheral neuropathy, and addiction in cocaine, amphetamines and opioids.  Full Article

Insys Therapeutics Inc provides update on dronabinol oral solution new drug application
Wednesday, 15 Oct 2014 04:30pm EDT 

Insys Therapeutics Inc:Announces that it has received a Refusal to File Letter from the United States Food and Drug Administration for its Dronabinol Oral Solution because it provided an inadequate or incomplete pediatric study plan in its New Drug Application (NDA) submission.Says the company believes that the additional information needed to address the pediatric study plan requirement is available without further clinical studies.Upon preliminary review, the FDA determined that the application was not sufficiently complete to permit a substantive review.According to the FDA letter and a subsequent informal meeting with the FDA, Insys provided an inadequate or incomplete pediatric study plan to conduct studies to assess the safety and effectiveness of Dronabinol Oral Solution in pediatric patients.  Full Article

Insys Therapeutics Inc receives FDA orphan drug designation for pharmaceutical cannabidiol as potential treatment for glioma
Monday, 29 Sep 2014 07:00am EDT 

Insys Therapeutics Inc:Says that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioma, which comprises about eighty percent of all malignant brain tumors.ODD includes pontine glioma (PG), a devastating form of primary brainstem glioma.  Full Article

Insys Therapeutics receives FDA Orphan Drug Designation for Pharmaceutical Cannabidiol
Monday, 25 Aug 2014 07:00am EDT 

Insys Therapeutics Inc:Says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM).Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S.  Full Article

Insys Therapeutics Inc submits NDA for its new oral formulation of dronabinol
Tuesday, 12 Aug 2014 07:34am EDT 

Insys Therapeutics Inc:Says it has submitted New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS.Says nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.Says Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol (THC).  Full Article

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