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)

FDA asks experts if pain drugs get second chance

WASHINGTON (Reuters) – U.S. drug regulators are asking experts for advice on whether companies should restart clinical trials for painkillers that help people with osteoarthritis and other conditions, but can destroy joints. The U.S. Food and Drug Administration said these drugs, from the class of anti-nerve growth factors, represent a potentially significant and novel strategy for the treatment of pain,” in a memo posted online on Thursday. …

FDA rejects AstraZeneca move on generic Seroquel

LONDON (Reuters) – Regulators have rejected a move by AstraZeneca that could have delayed the entry of generic versions of its top-selling antipsychotic Seroquel onto the U.S. market later this month. Britain’s second biggest drugmaker said on Friday the Food and Drug Administration had denied its Citizen Petitions requesting the agency withhold finally approving any generic with labeling that did not have certain warning language required for its branded version. …

Ex-FDA chemist gets 5 years for insider trading

WASHINGTON (Reuters) – A U.S. Food and Drug Administration chemist on Monday was sentenced to five years in federal prison after pleading guilty to insider trading by using confidential information about drug approvals. Cheng Yi Liang, 58, admitted buying and selling stock in more than two dozen companies with confidential FDA information to rack up just over $3.77 million in profits and avoid losses between July 2006 and March 2011. He pleaded guilty to two counts of securities fraud and making false statements. …

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