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In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Read More
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
President Biden yesterday revived a travel ban aimed at preventing the mutated strain of SARS-CoV-2 coronavirus first detected in South Africa from reaching the U.S. — and Moderna said it will launch a trial to evaluate a booster shot meant to provide additional protection against the mutated strain. Read More
Civica Rx, a two-year-old nonprofit organization founded by hospitals and philanthropic groups to address generic drug shortages in the U.S., announced it will build its first manufacturing facility. 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
FDA investigators observed multiple deficiencies during an October 2020 inspection of B. Braun Medical’s sterile IV fluids facility in Daytona Beach, Florida. 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
Lawmakers who want to tackle sky-high drug prices are going to have lots of new ammunition, thanks to the new hospital drug pricing transparency rule from the Centers for Medicare and Medicaid Services (CMS) and the analyses that are now starting to appear because of it. Read More
Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. Read More