The number of clinical trials that make it through to regulatory approval over the past decade is less than 8 percent, according to a new report on clinical success rates.…
Created by the prior administration to accelerate development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics, Operation Warp Speed (OWS) is an initiative in search of a new name,…
A specially convened UK clinical trial ethics committee has given the go-ahead for a COVID-19 human challenge study that is slated to start within weeks to help inform further vaccine…
The EU has struck new supply agreements with Moderna and Pfizer, boosting its total COVID-19 vaccine arsenal to up to 2.6 billion doses, enough to inoculate the bloc’s 446 million…
Acting FDA Commissioner Janet Woodcock rejected a proposal to put up a “firewall” between FDA staff involved in pre-submission interactions and staff working on post-submission drug and biologic reviews and…
GlaxoSmithKline (GSK) and Vir Biotechnology have teamed up to develop monoclonal antibodies for respiratory viruses, building off an existing agreement struck last year to develop COVID-19 therapies. Source: Drug Industry…
The EU yesterday unveiled a plan to speed up regulatory approvals and manufacturing of vaccines against emerging strains of the SARS-CoV-2 virus that causes COVID-19. Source: Drug Industry Daily
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Source: Drug Industry Daily
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving…
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan…