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
Liquid Biopsies Remain Wait and See for Some Clinicians
Circulating Biomarker Assays Promise to Refresh Cancer Profiling and Monitoring Practices
Four recently released reports paint a decidedly mixed picture of FDA’s ability to bring drugs and biologics to market. California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) fault FDA’s accelerated approval processes for favoring AIDS and cancer over diseases like diabetes, obesity, and heart disease. A Manhattan Institute report blames lack of development in these areas on the sky-high cost of Phase III trials, especially for heart-disease drugs. But a paper in NEJM suggests that FDA outstrips its European and Canadian counterparts in most areas of performance. And GAO concluded the agency met most of its performance goals between FY 2000 and FY 2010.