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The FDA has approved Remicade (infliximab), from Janssen Biotech, for the treatment of moderately to severely active Ulcerative Colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. The approval was supported by evidence from studies of Remicade in adults with Ulcerative Colitis plus additional data from a pivotal Phase III trial evaluating the efficacy and safety of Remicade in the treatment of pediatric patients. Results from the pediatric UC study presented in May 2011 showed that treatment with Remicade 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.
FDA approves anti-Helicobacter pylori antibody Gastroenterology Page
The FDA has given 510(K) approval to Ventana anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (H. pylori), from Ventana Medical Systems. This antibody is the first H. pylori antibody to receive such clearance and when used in immunohistochemical staining, aids in the detection of Helicobacter pylori, a bacterium linked to Chronic Gastritis, Ulcers and Stomach Cancer. The antibody provides pathologists unprecedented views of the bacterium, allowing for a more accurate patient diagnosis and is also fully integrated with the Ventana BenchMark XT and BenchMark Ultra slide staining instruments.
Napo Pharma terminates agreement wit Salix Pharma for crofelemer for Chronic Diarrhoea in AIDS patients Gastroenterology Page
Napo Pharma has terminated its agreement with Salix Pharma for failure of Salix Pharma to proceed with an application to the FDA for crofelemer for chronic diarrhoea in people living with HIV/AIDS, despite a successful Phase III result. Napo has filed a lawsuit against Salix seeking $150 million for breach of contract.
