FDAnews Drug Daily Bulletin

The FDA Friday approved a second indication for Regeneron Pharmaceuticals’ Eylea to treat macular edema following central retinal vein occlusion (CRVO).

While an impending update to the U.S. Pharmacopeia’s (USP) reference standard for heparin sodium will sharpen the drug’s monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8–0 against recommending approval of Cornerstone Therapeutics’ lixivaptan to treat hypervolemic hyponatremia associated with heart failure.

Watson Laboratories, Inc. issued a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg.

Cancer drugmaker Astex Pharmaceuticals said it would discontinue the development of its experimental small-cell lung cancer drug, Amuvatinib, as the drug failed to achieve a high enough response rate in patients in a mid-stage study.

Cancer drugmaker Astex Pharmaceuticals said it would discontinue the development of its experimental small-cell lung cancer drug, Amuvatinib, as the drug failed to achieve a high enough response rate in patients in a mid-stage study.

The osteoporosis drug denosumab reduced the number of tumor cells in patients with giant-cell tumor of the bone, researchers reported.

MorphoSys has better chances of finding a partner for its experimental arthritis drug after favorable results from a clinical trial, CEO Simon Moroney said.

Valeant Pharmaceuticals announced it has acquired Visudyne, used to treat abnormal growth of leaky blood vessels in the eye caused by wet age-related macular degeneration, from QLT.