GAITHERSBURG, Md. – An FDA panel of oncology experts Tuesday said Genentech Inc. and its parent company Roche AG should no longer be permitted to market Avastin (bevacizumab) in the U.S. as a treatment in combination with chemotherapy for HER2-negative metastatic breast cancer, agreeing that the firm's follow-up studies failed to confirm the magnitude of improvement in progression-free survival (PFS) observed in an earlier trial. (BioWorld Today)
GAITHERSBURG, Md. – An FDA panel Thursday said the risks of fetal exposure, increased heart rate, depression and other problems outweighed the benefits of weight loss for Vivus Inc.'s Qnexa (phentermine/topiramate). (BioWorld Today)
GAITHERSBURG, Md. – After two days of often very contentious debate over the validity and reliability of data from numerous studies of GlaxoSmithKline plc's Type II diabetes drug Avandia (rosiglitazone), an FDA panel said in a split vote that the drug should remain on the U.S. market, but with new warnings about heart attacks and under limited use. (BioWorld Today)
WASHINGTON – While the FDA determined that Vivus Inc.'s obesity pill Qnexa (phentermine/topiramate) met the agency's 2007 criteria for efficacy in weight loss, regulators said teratogenicity, along with metabolic acidosis and adverse psychiatric, cognitive and cardiovascular events were concerns of "particular interest" with the drug. (BioWorld Today)
WASHINGTON – Closely guarded briefing documents released by the FDA Friday morning revealed more details about the ongoing internal debate at the agency about whether GlaxoSmithKline plc's Type II diabetes drug Avandia (rosiglitazone) should be removed from the U.S. market. (BioWorld Today)
