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Anthony Fauci, the leading U.S. authority on infectious diseases, has cautioned against putting off second doses of Pfizer/BioNTech’s and Moderna’s vaccines to accelerate initial vaccinations, a strategy the UK is currently using and one President Biden has said he will adopt as vaccine makers experience delays in vaccine shipments. Read More
The U.S. International Trade Commission (ITC) has said it will investigate whether Chinese company Wuhan Healthgen Biotechnology is infringing two patents owned by Kansas-based Ventria Bioscience. Read More
The Biden administration has delayed an HHS rule that would have stopped community health centers from getting federal funds unless they charged low-income patients reduced out-of-pocket prices for insulin and injectable epinephrine. Read More
Italy is taking legal action against Pfizer for delays in supplying vaccine doses, contending the company is not honoring its supply contract and putting the country’s inoculation campaign at risk. Read More
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