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Shire on a roll as U.S. approves keenly awaited eye drug

Shire has won U.S. approval for its most important new medicine, a treatment for dry eyes, in a fresh boost for the company which completed its $32 billion acquisition of U.S. rare diseases specialist Baxalta last month. The Dublin-based drugmaker has been a big stock market winner following Britain's decision to leave the European Union, benefiting from the strength of the dollar against sterling and investor demand for defensive sectors like pharmaceuticals. Shire shares — already up a fifth since the UK referendum on June 23 — gained another 4 percent on Tuesday on news the U.S. Food and Drug Administration had approved lifitegrast eye drops for treating signs and symptoms of dry eye disease.

FDA staff say Vertex CF combo works, unclear how

(Reuters) – Vertex Pharmaceuticals Inc's combination of an experimental compound and an approved drug significantly improved lung function in cystic fibrosis patients with the most common genetic mutation underlying the disease, FDA staff said. The U.S. Food and Drug Administration staff reviewers, however, were not sure whether Vertex's already approved therapy, Kalydeco, had a positive effect alone. The FDA is trying to ask the panel if the evidence is enough to show that the combination's benefit is significantly better than that of a single component, RBC Capital analyst Michael Yee said. The FDA staff was satisfied with the safety profile of the combination, to be called Orkambi, according to documents released on Friday.