OrbeShield regulatory update

FDA granted Fast Track designation for Soligenix's OrbeShield to reduce mortality associated with gastrointestinal acute radiation syndrome (GI ARS). Soligenix plans to conduct a Phase I/II trial of the product in healthy adolescent and young adult volunteers. Last month, Soligenix said HHS's Biomedical Advanced Research and Development Authority (BARDA) invited the company to submit a full proposal for a potential multi-year, multi-million dollar contract to develop OrbeShield for GI ARS (see BioCentury, Jan. 21). ...