Ceplene histamine regulatory update

Germany's Federal Joint Committee (G-BA) said it plans to assess 12 drugs launched before drug pricing law AMNOG came into effect in January 2011, including Vidaza azacitidine from Celgene and Pfizer and Ceplene histamine from EpiCept to treat acute myelogenous leukemia (AML). Dossiers for the AML drugs are due June 1, 2014. The assessments may not happen because of a tentative agreement between German politicians to stop assessments of marketed products and instead continue the country's drug pricing freeze and mandatory rebates. G-BA said it would stop planned and ongoing assessments once new legislation is in the works. ...