Antibacterial Trials Can Benefit From Futility Analysis, Genentech Tells FDA
Adaptive designs and studies at multiple infection sites are among industry suggestions to the agency as possible new approaches to developing drugs to fight bacterial infections.
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Public/private working group’s “interim considerations” of how best to design clinical trials for VABP and hospital-acquired bacterial pneumonia would add symptom improvement to a mortality endpoint for the latter.
Both FDA and Congress are taking interest in combating antibiotic resistance, but FDA likely has more power to make headway in the near term, even as industry remains somewhat wary of that particular agenda item.
Cystic Fibrosis Market Snapshot: Disease-Modifying Drugs Elusive 24 Years After Discovery Of Root Cause
The discovery in 1989 of the underlying genetics causing cystic fibrosis was expected to spur broad development of disease-modifying therapies. As of 2013, however, only one such drug is on the market, for a small subset of CF patients, and a few other candidates are in clinical development.