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In his first presidential news conference yesterday, President Biden set a new goal of 200 million COVID-19 vaccinations by his 100th day in office — doubling his initial goal. Read More
AstraZeneca (AZ) responded to National Institutes of Health (NIH) concerns over its interim vaccine trial data by releasing its primary analysis results yesterday, but the embattled company’s two-dose shot faces intense scrutiny, with the European Medicines Agency (EMA) holding an expert meeting on March 29 to review possible links to blood clots. Read More
The test, which has also been cleared in Europe, is run on the company’s immunoassay analyzers, including its DxI 800 system, which can process up to 4,800 samples daily. Read More
A new report analyzing drug research and development (R&D) during the pandemic found that while cancer drugs have remained industry’s top focus, anti-infective drugs saw the biggest increase of all therapies due to the monumental efforts to combat the COVID-19 crisis. Read More
Johnson & Johnson (J&J) said it expects to deliver 20 million doses of its COVID-19 vaccine for the U.S. by the end of March, as officials nationwide continued to complain of severely limited supplies of the single-shot vaccine. Read More
As Europe continues to face challenges and setbacks in its COVID-19 vaccination efforts, the European Commission (EC) has proposed new criteria for vaccine export authorizations to conserve its supplies. Read More
Russian researchers are reportedly seeking approval for a single-dose version of the Sputnik V COVID-19 vaccine and are conducting clinical trials in Russia, the United Arab Emirates and Ghana. Read More
The COVAX vaccine-sharing program will stockpile 5 percent of its vaccine doses for high-risk populations in humanitarian settings or for emergency outbreaks, said Gavi, the Vaccine Alliance, which operates the global program alongside the World Health Organization and the Coalition for Epidemic Preparedness Innovations. Read More
Regeneron Pharmaceuticals’ and Roche’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), reduced the risk of hospitalization or death by 70 percent in high-risk nonhospitalized COVID-19 patients in a late-stage trial, the companies have said. Read More
Pfizer is conducting a U.S. phase 1 trial of an oral COVID-19 antiviral, PF-07321332, a protease inhibitor that can stop the virus from replicating. An oral drug would be much easier to administer than an intravenous formulation — a significant advantage during the pandemic. Read More
The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday. Read More