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

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…

Medicare Part D pays twice as much on average for hundreds of drugs as the Department of Veterans Affairs (VA), mostly because VA negotiates prices directly with drugmakers, the Government…

Most of the 53 novel drugs approved by the FDA in 2020 were reviewed through at least one expedited approval process, the agency said in a report on the year.…

AstraZeneca (AZ), Sanofi and Eli Lilly have each filed lawsuits against HHS, arguing the federal government can’t force them to provide 340B drug discounts to contract pharmacies. Source: Drug Industry…