Avandia's EU Judgment Day Postponed, But GSK Gets Some Good News From CHMP
This article was originally published in The Pink Sheet Daily
New fondaparinux indication cleared as European advisory panel says it take two more months to review of Avandia's cardiovascular risks.
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The FDA advisory committee re-review of cardiovascular safety risks with GlaxoSmithKline's Avandia (rosiglitazone) will not end calls from agency critics to create a separate drug safety center. However, the transparency of internal scientific disputes on display at the July 13-14 meeting and the committee's recommendations could take some ammunition away from those who assert the Center for Drug Evaluation and Research has given short shrift to safety issues
Twenty of 33 committee members vote to keep rosiglitazone on the market, with most favoring stronger labeling and restrictions on prescribing.
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.