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The FDA is calling for risk assessments by cell and gene therapy (CGT) manufacturers to minimize the potential for transmitting the SARS-CoV-2 virus through their products, according to a new straight-to-final guidance released yesterday. Read More
Under the Biden administration, the U.S. will join the World Health Organization (WHO)’s COVAX program and may potentially contribute billions of dollars toward providing access to COVID-19 vaccines in low- and middle-income nations, though it’s not yet known how much money the president will pledge. Read More
Pfizer and BioNTech released new study results yesterday indicating their COVID-19 vaccine would likely induce immunity for all 10 mutations on the spike protein of the SARS-CoV-2 viral strain identified in the UK, but other research suggests the vaccine might not be effective against new variants. Read More
Maryland’s state Senate has voted to overrule Gov. Larry Hogan’s veto of a bill to fund the state’s Prescription Drug Affordability Board (PDAB), an independent entity meant to cap prices for costly drugs in the state by 2022. Read More
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. Read More
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. Read More
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Read More
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. Read More
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. Read More
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. Read More
FDA veteran Janet Woodcock has reportedly been short-listed by the incoming Biden administration to serve as the agency’s next commissioner and will also likely serve as acting chief until the position is filled. Read More