Systems Biology Opens New Research Pathways
Systems Biologists Are Attacking the Encrypted Messages That Would Allow Us to Predict and Change the Course of Disease
Individual Tumor Profiling
Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?
Top 10 Under 40
Up-and-Coming Stars Shine in Biopharma Research and Business
Podcast: FDA’s New Commissioner Hits the Ground Running
Scott Gottlieb, M.D., Commits to Speeding Up Drug Reviews, and Maintaining Safety and Efficacy
Vivus' Obesity Drug Development
On February 22, an FDA advisory committee voted 20 to 2 in favor of Vivus’ anti-obesity drug Qnexa, concluding that its weight loss benefits outweighed its potential risks. While not bound by committee recommendations, the FDA will consider the guidance during its review, scheduled for April 2. The committee decision marked the end of a long road for Qnexa, which had been rejected by the agency in September 2010 in a 10–6 vote. The reason was not a lack of efficacy but its side effects including serious birth defects and heart problems. If the FDA green-lights Qnexa, it is expected to assuage concerns by asking for a post-approval cardiovascular outcomes study. Do you think FDA will okay Vivus’ anti-obesity treatment without further clinical investigation?