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FDA grants orphan drug status to RiVax

The US Food and Drug Administration (FDA)has given orphan drug status to Soligenix's ricin intoxication preventive, RiVax. Soligenix has completed a Phase 1A clinical trial of RiVax which showed that the immunogen was safe and induced antibodies anticipated to protect humans from ricin exposure. Further, the company is continuing Phase 1B trial of RiVax. Soligenix president and CEO Christopher Schaber said the FDA's decision to grant RiVax orphan drug designation for the prevention of ricin intoxication marks another important step forward in their biodefense pipeline.

"Marketing exclusivity through orphan drug designation adds significantly to the existing patent estate surrounding RiVax," Schaber said.

(pharmaceutical-business-review.com)

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