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News Breaks
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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March 24, 2015
08:35 EDTHEBHemispherx receives positive opinion on application for Orphan designation
Hemispherx Biopharma announces that the European subsidiary, "Hemispherx Biopharma Europe N.V./S.A" gained a positive opinion from the COMP (Committee on Medical Products) regarding its Orphan Medicinal Product Application for Ampligen, an experimental therapeutic, to treat Ebola Virus Disease, or EVD. The dossier submitted to the EU contained an inventory of relevant pre-clinical research in EVD therapeutically-oriented models, as well as, clinical safety information derived from non-EVD clinical studies of Ampligen. Of potentially high relevance to the favorable COMP opinion were experiments, conducted in Italy, which showed that, in vitro, Ampligen successfully competed with Ebola viral dsRNA in a manner which may result in loss of virulence by EBOV.
March 19, 2015
07:14 EDTHEBWall Street Analyst Forum to hold a conference
25th Annual Investor Conference is being held in New York on March 19.

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