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News Breaks
December 20, 2012
20:08 EDTHEBHemispherx fatigue drug Ampligen rejected for approval, WSJ reports
An FDA panel voted 8-to-5 against approval of Hemixpherx's (HEB) chronic fatigue drug Ampligen at an FDA Arthritis Advisory Committee Meeting Thursday, according to a Wall Street Journal report. Reference Link
News For HEB From The Last 14 Days
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July 23, 2015
08:36 EDTHEBHemispherx announces final approval of securities class action settlement
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July 15, 2015
08:35 EDTHEBHemispherx submits ODD application to EMA for Alferon N Injection
Hemispherx announces that they have submitted an application for orphan drug designation to the European Medicines Agency, or EMA, for Alferon N Injection, an experimental therapeutic, to treat Middle East Respiratory Syndrome, or MERS. The EMA as determined the application to be valid, and the Committee for Orphan Medicinal Products, or COMP, has initiated the official review process. It is anticipated that the COMP will give an opinion on the application within the next 90 days. There are significant benefits for achieving Orphan Designation, including eligibility for grants from EU and Member State programs. Designated orphan medicines are assessed for marketing authorization centrally in the European Union with reductions/waivers in the fees and costs of the overall regulatory process. The designation allows companies to make a single application to the European Medicines Agency, resulting in a single opinion and a single decision from the European Commission, valid in all EU Member States. Authorized orphan medications, once commercially approved, receive benefits including ten years of complete protection from market competition with similar medicines.

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