Merck KGaA resubmits oral MS drug to FDA

Seven months after the FDA sent Merck KGaA back to the drawing board for new work on its application for the oral MS drug cladribine, the German pharma company says it has resubmitted the closely watched therapy for an approval. The agency had rejected Merck's original application, but the pharma company declined to say exactly what the FDA wanted them to do to fix it. Several analysts believe that the therapy is an odds-on favorite for approval. Novartis, meanwhile, will present its oral MS drug Gilenia to an advisory committee on Thursday, giving it a clear lead in the race to the market. Report