Archive for January 2021
David Kessler to Take Reins as Operation Warp Speed’s Scientific Leader
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
Read MoreModerna Will Evaluate Booster Shot for COVID-19 Vaccine in New Trial
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
Read MoreHHS Issues Final Rule Imposing Renewable Term Limits for FDA Directors
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
Read MoreTrio of Drugmakers File Lawsuits Against HHS Over 340B Discounts
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
Read MoreMost FDA Approved Novel Drugs in 2020 Went Through Accelerated Reviews
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
Read MoreMedicare Pays Twice as Much as VA for Many Drugs, GAO Finds
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
Read MoreReport Touts FDA’s Actions in Responding to the Pandemic
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
Read MoreFDA More Selective About Convening Advisory Committee Panels During Pandemic
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
Read MoreHacked Documents on COVID-19 Vaccines Were ‘Manipulated,’ EMA Says
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
Read MoreFDA Recommends Labeling Update for Laparoscopic Power Morcellators
The FDA has issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue and on the use of LPM containment systems. Source: The GMP Letter
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