After a long, painful revamp, Merck KGaA scores key OK for once-defunct MS drug cladribine
Merck KGaA’s failure with its MS drug cladribine six years ago triggered a long and painful revamp in its R&D group, earning the German pharma company a rep for failure that stained everything they did. Its comeback today with a European approval may also serve as notice that the turnaround that was long promised has actually begun.
Merck KGaA never quite fully let go of the cladribine program, after its researchers managed to come up with one of the worst late-stage development plans in the field. Its single Phase III raised safety questions on cancer that took years to address. But researchers finally came up with new data and results that won over regulators at the EMA, who were quick to turn thumbs down on the first attempt.
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