GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it…
Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone
May 29, 2013 by Leave a Comment
An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary two-day FDA advisory committee meeting next…
FDA Schedules Another 2 Day Avandia Advisory Panel
April 12, 2013 by Leave a Comment
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to “discuss the results…
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