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News Breaks
December 17, 2012
06:28 EDTHEBHemispherx's fatigue drug to be reviewed again by FDA, WSJ reports
A potential treatment for chronic fatigue syndrome will be reviewed again this week when an FDA panel looks at Hemispherx Biopharma's (HEB) experimental drug Ampligen, reports the Wall Street Journal. The drug has been in development for chronic fatigue syndrome for about two decades, but in 2009 the FDA refused to approve it, saying clinical studies submitted for approval of the product didn't provide "credible evidence" of the drug's effectiveness. Reference Link
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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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