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February 4, 2013
19:39 EDTHEBFDA declines to approve Hemispherx's Ampligen new drug application
Hemispherx Biopharma announced that it received a complete response letter from the US Food and Drug Administration declining to approve its new drug application for Ampligen for Chronic Fatigue Syndrome. The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its complete response letter, the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the office of new drugs in the FDA's center for drug evaluation and research regarding the agency's decision
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June 25, 2015
16:13 EDTHEBHemispherx files $77.9M mixed securities shelf
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08:36 EDTHEBHemispherx receives notice of intention to grant patent from EU
Hemispherx announced that it received formal notice on June 18, that the European Patent Office's Examining Division issued the formal notification of intention to grant the Hemispherx application titled "Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity" by inventors Carter, et al. and assignee Hemispherx Biopharma, Inc. The patent claims a novel form of rugged dsRNA. Rugged dsRNA are nucleic acids with a unique composition and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3, or TLR3, thereby conveying an important range of therapeutic opportunities. This form of dsRNA has increased bioactivity and binding affinity to the TLR 3 receptor because of its reduced tendency to form branched dsRNA that can inhibit receptor binding. Pharmaceutical formulations containing this nucleic acid as active ingredients, and methods of treatment with those formulations, are also described in the accepted application.

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