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Roche haemophilia drug wins fast-track FDA designation – Reuters

By September 8, 2015News
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Roche said on Friday it had won breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental haemophilia medicine, aiming for a piece of the $11 billion haemophilia drug market.

The Swiss drugmaker said its U.S.-based Genentech unit’s ACE910 secured the fast-track designation as the company prepares separate Phase III trials in 2015 and 2016, the first in patients with haemophilia A with factor VIII inhibitors and the second for patients without inhibitors.

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