Breaking News, Trials & Filings

DiaVacs T1DM Immunotherapy Gets Orphan Status

Phase II diabetes trial begun

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

DiaVacs has received Orphan Drug Designation from the FDA for DV-0100, the company’s type 1 diabetes mellitus (T1DM) therapy. DV-0100 is a proprietary, novel and safe immunotherapy that halts the body’s autoimmune reaction against the pancreatic islet cells that are responsible for producing insulin. This allows them to produce insulin normally and can reverse the trajectory of the disease. Orphan designation qualifies DV-0100 for seven years of marketing exclusivity in the U.S. if ...

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