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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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January 26, 2015
08:34 EDTHEBHemispherx reports genetic changes in Ebola may impede potential treatments
Hemispherx Biopharma announced that in a new publication in the journal mBio, scientists at the U.S. Army Medical Research Institute of Infectious Disease, or USAMRIID, Harvard University, and Massachusetts Institute of Technology, or MIT, studied genetic changes in the Ebola virus, or EBOV, circulating in West Africa and concluded that genomic drift of the EBOV over time may be sufficient to block the action of otherwise potential therapies that target EBOV genetic sequences. The types of potential drugs at risk include monoclonal antibodies and small-interfering RNA which are scheduled to be evaluated during the current outbreak. The two platform drugs of Hemispherx, Alferon N and Ampligen, both experimental therapeutics in a setting of Ebola disease, have recently both demonstrated anti-EBOV activity and have mechanisms of action which are multifaceted by working through cellular "molecular cascades" rather than by targeting viral protein or genetic sequences whose specificity is vulnerable to mutational change as reported by the research consortium on January 20. Although none of the experimental drugs have been approved by the FDA, certain of the experimental therapeutics discussed in the USAMRIID/Harvard/MIT report, are being used to treat small numbers of patients under a World Health Organization, or WHO, emergency protocol. The potential impact of genomic drift on development of therapeutics for EBOV disease has already been realized for other pathogenic human virus, such as HIV and influenza. The large genetic and antigenic diversity seen in HIV has been a "major stumbling block" for development of preventative vaccines.
January 15, 2015
08:34 EDTHEBHemispherx awarded $770,852 by federal judge
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