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ActoBio announces FDA has given permission to an Investigational New Drug (IND) application for Actobiotics® AG017, a therapeutic candidate for celiac disease.

“Fail faster” is a saying in drug research. In 2014, the Tufts Center for the Study of Drug Development estimated that the average cost of bringing a new drug through the development pipeline and Food and Drug Administration (FDA) approval process to market is $2.6 billion. More than 90 percent of all drugs being developed…

ImmusanT, a biotechnology company focusing on protecting patients with celiac disease against the effects of gluten, has announced that it has secured $40 million in funding to advance its drug, Nexvax2®, into a Phase II clinical trial. Nexvax2 is a therapeutic vaccine designed to stimulate immune tolerance in patients with celiac disease. Nexvax2® is the…

Celiac Disease Foundation is proud to have been a funder and to participate on the Steering Committee for the FDA Gastroenterology Regulatory Endpoints and Advancement of Therapeutics (GREAT3) workshop. Conceived by Dr. Sonia Kupfer of the University of Chicago and CDF Medical Advisory Board member Dr. Daniel Leffler of Beth Israel Deaconess Medical Center, GREAT3…

Celiac Disease Foundation is pleased to announce the March 30-31, 2015, U.S. Food and Drug Administration (FDA) public workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT3). This scientific meeting will address endpoints and outcome measures for clinical trials for products intended to treat adult and/or pediatric celiac disease and inflammatory bowel disease.