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March 20, 2014
08:02 EDTEGRXEagle Pharmaceuticals says FDA acceptsa NDA for Ryanodex
Eagle Pharmaceuticals announced that the United States Food and Drug Administration has accepted the company’s New Drug Application for Ryanodex and granted a priority review classification. The PDUFA date is July 22. In January 2014, Eagle filed its NDA with the FDA for the treatment of malignant hyperthermia. In February 2014, the FDA conditionally accepted Eagle’s trade name Ryanodex. Ryanodex has previously been granted Orphan Drug designation and Eagle currently owns three U.S. patents covering the product. Eagle intends to commercialize Ryanodex after approval and will retain exclusive marketing rights in the U.S.
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October 6, 2015
07:02 EDTEGRXEagle Pharmaceuticals completes clinical treatment portion of Ryanodex study
Eagle Pharmaceuticals announced that the company has successfully completed the clinical treatment portion of its safety and efficacy study to evaluate RYANODEX for Exertional Heat Stroke. The first of its kind study was conducted from September 22-27, 2015 at the Hajj pilgrimage in Saudi Arabia. Due to the unpredictable and sudden nature of EHS, the study was conducted in an emergency and acute-care medical setting. In this study, 34 EHS patients were randomized to receive current standard of care treatment or SOC plus RYANODEX. Based on preliminary study results, participants who received RYANODEX in combination with the SOC showed no significant drug-related adverse events. The company believes this patient cohort is a sufficient number of subjects to enable assessment of a clinically meaningful treatment effect of RYANODEX in EHS. Eagle expects to complete the clinical data analysis during the fourth quarter of 2015.
September 29, 2015
08:02 EDTEGRXEagle Pharma receives new patent for bendamustine rapid infusion product
Eagle Pharmaceuticals (EGRX) announced that the United States Patent and Trademark Office has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride formulation administered in a 50mL bag within ten minutes. The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents, further expands and protects Eagle's bendamustine HCI intellectual property estate. The Prescription Drug User Fee Act goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle's rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture. The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. (TEVA) entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.
September 28, 2015
07:14 EDTEGRXZIOPHARM names Eagle Pharmaceuticals CEO to board
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