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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
Roche’s blockbuster oncology drug Tecentriq (atezolizumab) met its primary endpoint of disease-free survival in its phase 3 lung cancer study evaluating the drug as an adjuvant therapy, according to an interim analysis. Read More
AstraZeneca’s (AZ) COVID-19 vaccine clocked in at 79 percent efficacy in preventing symptomatic infection and fully shielded against severe disease and hospitalization in the company’s phase 3 U.S. trial, opening the door for an Emergency Use Authorization (EUA) filing with the FDA in a matter of weeks. Read More
Merck’s blockbuster oncology drug Keytruda (pembrolizumab) significantly improved survival for women suffering from endometrial cancer when combined with Eisai’s Lenvima (lenvatinib) in a late-stage clinical trial, the companies announced Friday. Read More
In another blow to AstraZeneca’s (AZ) COVID-19 vaccine, a peer-reviewed study has found that it failed to protect against mild-to-moderate infections caused by the virus’ South African variant. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, an over-the-counter (OTC) drugmaker in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
Moderna is working to widen the utility of its COVID-19 vaccine and, over the past week, announced that it has begun to study its vaccine in kids aged six months to 11 years old, that it is testing a version of its vaccine that can be stored at warmer temperatures and that it launched a study of a modified COVID-19 vaccine to target the variant strain first identified in South Africa. Read More