Merck KGaA back on track with MS drug

After first getting unexpectedly stiff-armed by the FDA, Merck KGaA says that its app for the oral MS therapy cladribine has now been granted a priority review, putting it on track for a fourth-quarter decision. The German pharma company has been trailing Novartis recently in the race to the market with the world's first oral MS drug. An expert panel has already voted to endorse Novartis' Gilenia....

Stymied in U.S., Merck KGaA wins an approval for cladribine

As Merck KGaA wrestles with FDA regulators over its application for the oral MS drug cladribine, the German pharma company won its first approval for the drug--in Russia. Merck KGaA's cladribine filing was stiff-armed at the FDA last fall when the agency refused to accept it for review. The pharma company refiled in the U.S. in June. But Russia has already offered its approval, and Merck Serono says it expects more markets to follow in short order. "This is an important milestone...

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...