FDA accepts investigational NDA for ulcerative colitis therapy

The FDA accepted the investigational new drug application for ABX464 for the treatment of patients with moderate to severe ulcerative colitis, according to the drug’s manufacturer.Currently, researchers are assessing ABX464 (Abivax) across 15 European countries and in Canada in 232 patients with moderate to severe UC. This FDA clearance allows the phase 2b trial to…

Crohn’s & Colitis Congress: Collaboration between physicians, patients ‘critical’

AUSTIN, Texas — Healio Gastroenterology and Liver Disease will be on-site at the Austin Convention Center starting Thursday as a media partner for the Crohn’s & Colitis Congress, bringing the latest in inflammatory bowel disease news to our daily feed.The Congress, which is in its third year, according to David T. Rubin, MD, AGAF, section…

FDA grants orphan drug designation to durvalumab-tremelimumab combination for liver cancer

The FDA granted orphan drug designation to the combination of durvalumab plus tremelimumab for treatment of patients with advanced hepatocellular carcinoma.Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1. It inhibits interaction of PD-L1 with PD-1 and CD80. Tremelimumab (MedImmune/AstraZeneca) is an investigational anti-CTLA-4 monoclonal antibody.The ongoing phase 3 HIMALAYA trial is…