Antibiotic Resistance Gets Attention Of FDA, Congress
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Reinvigorated Antibiotics Pipeline Could Produce Four NMEs In 2014
With two novel antibiotics approved and two more under review, 2014 is seeing the end of a long lean period for antibacterial R&D, helped by incentives like Qualified Infectious Disease Product designation. But only one candidate, Cubist’s ceftozolane/tazobactam, addresses the urgent need to target resistant Gram-negative bacteria.
Dalvance: First QIDP Antibiotic Breaks New Regulatory Ground; Label Doesn’t
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.
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.