BioCentury
ARTICLE | Clinical News

Amphinex regulatory update

October 31, 2011 7:00 AM UTC

PCI said EMA's CHMP recommended the biotech develop Amphinex as a single product for use with bleomycin to treat head and neck cancer instead of a combination package of Amphinex and bleomycin. The biotech said it will continue to develop the combination package, designated as PC-A11, while evaluating its options. PCI sought advice from CHMP on how EMA would evaluate an MAA for PC-A11 after regulatory agencies in the U.K., Sweden and the Netherlands indicated support for a combination package. ...