FDA eye drug rebuff adds to Shire’s woes in Baxalta pursuit
(Reuters) – Shire Plc suffered a setback for its most important pipeline medicine late on Friday, adding to the group's problems as it pursues Baxalta Inc to forge the leading global specialist in rare diseases. The Irish company said the U.S. Food and Drug Administration (FDA) had declined to approve its new eye drug lifitegrast and had requested an additional clinical study. The news comes just over a week before the FDA was supposed to make a decision on the treatment for dry eye disease, which analysts have penciled in as a potential $1 billion-a-year-plus seller.