The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Gamifant faces challenges in Europe
Gamifant from Sobi, Inc. is an interferon gamma (IFNγ) blocking antibody that is FDA-indication to treat adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH). The indication covers refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. First approved in the U.S. in 2018, Gamifant has run into regulatory roadblocks in Europe. The European…