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Chimerix And FDA’s Compassionate-Use Solution

A media storm is over and Chimerix has resumed focus on the Phase III trial of its lead program, thanks to quick work by the company and FDA to design a trial providing access to brincidofovir in immunocompromised patients with adenovirus.

Compassionate-use requests for experimental but potentially life-saving medicines are not unusual in the drug industry, nor are denials of those requests. Industry and regulators try to focus on the big picture of getting drugs to patients in the safest and fairest way possible, which generally requires getting them to market through controlled clinical trials.

But Chimerix Inc. and FDA reached a solution in a challenging ethical case related to the company’s antiviral brincidofovir...

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