GAIN Begins (Part 2): Infectious Disease Society and Start-Up Companies Push for More

The ink is barely dry on new antibiotic incentives in the GAIN Act, but the anti-infective development community is pushing for more. New ideas include “pull” incentives modeled on biodefense programs.

The first responses from start-up companies and the investment community to the anti-infective development incentives in the Food & Drug Administration Safety & Innovation Act indicate that longer exclusivity awards may not be enough to support expanded development on products for emerging resistant pathogens.

While there continues to be activity around new companies in the resistant pathogen area, and FDA officials cite signs of...

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