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More than two dozen PhRMA members have sent a letter to President Biden, imploring him to oppose India’s and South Africa’s proposal to the World Trade Organization (WTO) to waive intellectual property (IP) rights for COVID-19 innovations during the pandemic. Read More
A Pfizer plant that will produce the company’s COVID-19 vaccine has been observed by FDA investigators as having quality control lapses, but Pfizer says the problems will be resolved before the facility supplies any COVID-19 vaccine doses. Read More
The Senate passed a $1.9 trillion COVID-19 relief bill on Saturday in a 50-49 vote along party lines, including a $500 million appropriations injection for the FDA — equivalent to a 16 percent increase in the agency’s fiscal year 2021 funding. Read More
Brii Biosciences announced that its investigational monoclonal antibodies BRII-196 and BRII-198 failed to reach the minimum required efficacy rate for hospitalized patients and will not move on to the late stage of the National Institutes of Health’s (NIH) ACTIV-3 trial. Read More
A small study of Sinovac’s CoronaVac vaccine has found that it doesn’t appear to protect against a newly identified coronavirus variant in Brazil. Read More
Canada has issued an interim authorization for Johnson & Johnson’s (J&J) single-shot COVID-19 vaccine, allowing its use for preventing COVID-19 infections in patients age 18 and older. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s monoclonal antibody bamlanivimab as a COVID-19 treatment, as well as in combination with etesevimab. Read More
An FDA expert panel on vaccines met on Friday to review strains to include in influenza vaccines for the next flu season and heard that the COVID-19 pandemic has changed the production landscape. Read More
The UK’s RECOVERY trial, which is assessing multiple potential COVID-19 treatments, has stopped enrollment in its arm evaluating colchicine, an anti-inflammatory drug used to treat gout. Read More