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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.

Merck cholesterol drug’s odds dim after Lilly failure

The odds that Merck & Co’s high-stakes cholesterol drug will succeed have dropped dramatically after Eli Lilly and Co said its similar medicine failed to reduce heart attacks and strokes, top U.S. heart doctors said. Lilly on Monday said it was halting a 12,000-patient study of its drug, evacetrapib, an oral medication. In earlier studies, the treatment cut “bad” LDL cholesterol by 30 to 35 percent and doubled the levels of “good” LDL cholesterol.

FDA approves Emergent BioSolutions’ inhaled anthrax treatment

Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the Department of Health and Human Services (HHS). The company developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research and Development Authority (BARDA), a part of the HHS. Anthrasil, which is approved in combination with other antibacterials, is already being stored in the U.S. Strategic National Stockpile, the company said on Wednesday. The drug is made using plasma from healthy, screened donors who have been immunized with Emergent Bio's Anthrax vaccine, BioThrax, the only FDA-licensed vaccine for the disease.