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 exec to become Millipore CEO

Merck KGaA executive Bernd Reckmann has been tapped as the new CEO of Millipore, which the German company bought back in March. Current Millipore CEO Martin Madaus will work as a consultant for the company after the $6 billion acquisition is complete....

Merck KGaA’s pancreatic cancer vaccine ready for testing

In the quest for a cancer vaccine, Merck KGaA is again stepping into the ring. Vaximm Holding AG, the company's joint venture with a Switzerland's BB Biotech Ventures III, will start testing a therapeutic cancer vaccine in patients next year. The vaccine, VXM01, harnesses the body's immune system to fight cancer by using T-cells to close off the tumor's blood supply. Roche's Avastin also focuses on the tumor's blood supply, but it focuses on eliminating a protein that creates the...

Merck KGaA gets green light on lung cancer vax trials

Merck KGaA got the green light from the FDA to restart its late-stage lung cancer program for its therapeutic vaccine Stimuvax, which had been halted after a patient in a multiple myeloma trial contracted encephalitis in March. Licensed from Oncothyreon, the German pharma company has made a committed effort to bring in a trove of late-stage data on a range of cancers for its closely-watched therapeutic vaccine. Investigators now have an approval to ramp the lung cancer trials back up while...

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...