WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New Jersey-based pharmaceutical company, today announced that its product RYANODEX® (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA’s Coronavirus Treatment Acceleration Program (“CTAP”) to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.
Bristol-Myers Squibb Company (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) today announced that the New England Journal of Medicine (NEJM) has published results from MEDALIST, the pivotal phase 3 study evaluating the use of Reblozyl® (luspatercept-aamt) to treat anemia in patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts (RS+) and require red blood cell transfusions, and who had failed, were intolerant to, or ineligible for/unlikely to respond to treatment with erythropoiesis-stimulating agents (ESAs).1
Enforcement Report - Week of May 8, 2019
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced positive results of its study to evaluate the neuroprotective effects of RYANODEX® (dantrolene sodium) secondary to nerve agent (NA) exposure, conducted with the United States Army Medical Research Institute of Chemical Defense (USAMRICD), the nation's leading science and technology laboratory in the area of medical chemical countermeasures research and development.
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or “the Company”) today announced that the Company has been issued a new patent related to its RYANODEX® product (dantrolene sodium for injectable suspension) by the United States Patent and Trademark Office (USPTO). Patent number 9,884,044 will expire June 2022. The USPTO has now issued or allowed a total of seven patents in the RYANODEX family of patents expiring between 2022 and 2025. The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
Shares of Eagle Pharmaceuticals $EGRX tanked Wednesday afternoon after the biotech reported that the FDA has snubbed its pitch to market its drug Ryanodex for heat stroke. And this rejection may take awhile to overcome.
Hikma Pharm’s Generic Dantrolene Sodium Receives Approval In US
On April 27, 2016, Eagle Pharmaceuticals, Inc. (“Eagle”) filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA violated the Administrative Procedure Act (“APA”) when the Agency refused to grant periods of 7-year orphan drug exclusivity upon the December 7, 2015 approval of Eagle’s 505(b)(2) NDA 208194 for BENDEKA (bendamustine HCl) Injection, 100 mg/4 mL (25 mg/mL) for both the treatment of patients with Chronic Lymphocytic Leukemia (“CLL”) and for the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. We suspected that a lawsuit against FDA might be in the works when Eagle announced in late March 2016 that FDA refused to grant orphan drug exclusivity for BENDEKA and that the company was “evaluating all options to challenge the FDA’s decision.”
Mylan Institutional`s Generic Dantrolene Sodium approved in US as postsynaptic muscle relaxant
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.