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FDA staff questions Clovis drug’s efficacy over current treatments

(Reuters) – Staff reviewers from the U.S. Food and Drug Administration on Friday questioned if Clovis Oncology Inc’s lung cancer drug was more effective than available treatments. The reviewers also recommended including a black box warning, the FDA’s strictest warning, in the drug’s label. (http://1.usa.gov/1WhpSFa) Rociletinib, which is very similar to an AstraZeneca Plc drug already on the market, targets patients whose disease has worsened after treatment with other therapies. (Reporting by Amrutha Penumudi and Natalie Grover in Bengaluru; Editing by Sriraj Kalluvila)

Zafgen’s obesity drug succeeds in mid-stage trial

(Reuters) – Drug developer Zafgen Inc said on Thursday that its drug to treat obesity in diabetic patients met the main goal of reducing body weight. Patients given 1.8 mg and 1.2 mg doses of the drug, beloranib, experienced 12.7 and 13.5 percent reduction in body weight, respectively. Last month, Zafgen said the drug was also successful in treating Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening obesity, in a late-stage trial.

Zafgen says patient dies in obesity drug trial

(Reuters) – Drug developer Zafgen Inc said a patient died from a blockage in an artery in the lung in a late-stage study of its experimental obesity drug. The company said it is discussing with the U.S. Food and Drug Administration on the next steps for the drug, beloranib. (Reporting by Vidya L Nathan in Bengaluru; Editing by Saumyadeb Chakrabarty)