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BioWorld-Insight-2010-12-27
FDA vs EMA: One Molecule, Two Different Conclusions
Manufacturing, Marketing And Distribution Agreements Between Biotech Companies: Nov. 1 - Dec. 23, 2010
No Abstract
FDA vs EMA: One Molecule, Two Different Conclusions
Earlier this month, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for InterMune Inc.'s idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone). The European Medicines Agency (EMA) is expected to ratify the decision in a few months, clearing the way for InterMune to launch the drug in Europe. (See BioWorld Today, Dec. 20, 2010.)