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The Biden administration is facing a tall order to meet its goal of vaccinating 100 million Americans in its first 100 days, given the weaknesses and ongoing delays in the country’s decentralized distribution and vaccination process. Read More
Janet Woodcock stepped into her new role as acting FDA Commissioner this week, pledging in an email to agency staff to maintain the agency’s science-based approach. “The American people can be certain that science — above all — will continue to guide the FDA’s regulatory actions now and into the future,” she said. Read More
Drugmakers contend that the 340B drug program’s expansion to include contract pharmacies not owned by covered entity hospital creates the potential for duplicate discounts. Read More
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