Weaknesses In Gilead's Remdesivir Trial Designs Unlikely to Impact Approval Prospects In US
Urgency of the COVID-19 crisis, political pressure, and trends in FDA reviews all point in favor of Gilead, despite the company's decision to conduct open-label Phase III trials for remdesivir and only one study with a control arm.
You may also be interested in...
COVID-19 Shifts ICER Pricing Targets, Creating New Hurdles For Drug Developers
With a remdesivir analysis pushing cost-recovery models and lower thresholds for cost-effectiveness, ICER's COVID-19 pricing framework will likely result in lower pricing benchmarks for drugs than the group would have issued under its typical analysis framework. Critics say this is the opposite of what should be incentivized in an emergency.
Coronavirus Update: Coalition Aims To Overcome 'Disjointed' COVID-19 Trials, Gilead's Open Label Criticized
NIH's Collins brings together coalition after months of behind-the-scenes work. Meanwhile, Gilead's remdesivir trials are the center of huge expectation and controversy.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.