Genetic Disorders

FDA still not completely satisfied with Kamada’s inhaled AAT drug(Synthetic Biologics) Kamada is stuck again with a new obstacle in its way to bring the first inhaled treatment for alpha-1 antitrypsin (AAT) deficiency in the market as an alternative to currently present intravenous drugs. The company specializes in developing drugs from plasma proteins.  FDA is still not completely satisfied with the proposed phase 3 protocol for nebulized AAT. Due to this problem the company won’t likely be able to start the trial before the end of the year as hoped. FDA Snatches breakthrough designation from Synthetic Biologics after discovering death imbalance in trial data US based...