Archive for January 2021

Former FDA Commissioner David Kessler is set to become Operation Warp Speed’s new chief science officer as just a single day remains until the Biden presidency takes up the mantle for accelerating COVID-19 vaccinations and countermeasures. Source: Drug Industry Daily

Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in the works, the company disclosed last week. Source: Drug Industry Daily

Another last-minute Trump administration policy was issued at the end of last week by HHS that requires five-year, renewable term limits for directors of all agencies under the department, including the FDA. Source: Drug Industry Daily

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 Daily

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. Source: Drug Industry Daily

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 Accountability Office (GAO) has found in a new analysis. Source: Drug Industry Daily

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 (PREPP) initiative that includes a dozen recommendations for improving the agency’s response going forward. 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 panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based research firm. 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