News

For years, Duchenne muscular dystrophy drug trials included a specific endpoint requiring that they enroll only patients who were still able to walk. That changed when a DMD-focused advocacy organization took the matter up with the FDA and helped develop new trial guidelines.

The festivities marking the late 2019 holiday season in Europe have been spoiled by a disconcerting message about the declining efficiency of investments in pharmaceutical research, in the shape of a lengthy report from the European Union on industry’s innovative capacity.

The European Union system for pharmacovigilance “is operating effectively and efficiently” concludes a report.

The latest happenings in the clinical trials industry from the past month, all in one place.

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

David Arthur, CEO of Salarius, discusses how companies like Salarius are incorporating endpoints into early-stage clinical trials that could offer a glimpse into efficacy.

Doug Manion, CEO of Kleo, explains how platform technology essentially involves the engineering of antibodies and biologics using linear process chemistry to enhance drug effectiveness.