FDA panel recommends Glaxo’s Votrient for sarcoma

WASHINGTON (Reuters) – A Food and Drug Administration panel on Tuesday recommended GlaxoSmithKline Plc’s Votrient for treatment of advanced soft-tissue sarcoma, a relatively rare but aggressive form of cancer. The FDA advisory committee of outside experts voted 11-2 to find that the drug’s ability to improve short-term survival without worsening symptoms in patients who receive chemotherapy outweighed adverse risks and a lack of evidence that it can extend overall survival. (Reporting by David Morgan; Editing by Lisa Von Ahn)

AstraZeneca sues FDA over generic Seroquel

A worker leaves the AstraZeneca research facility in LoughboroughLONDON (Reuters) – AstraZeneca said on Tuesday it was suing the Food and Administration after the U.S. regulator refused to delay the market entry later this month of generic versions of top-selling antipsychotic Seroquel. The drugmaker is seeking an injunction barring the FDA from granting final marketing approval of generic forms of the drug, whose chemical name is quetiapine, until December 2, 2012, or at least until a federal court has a chance to review the agency’s action. …

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