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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
Due to positive results, a phase 3 trial for Sanofi’s and Regeneron’s Libtayo (cemiplimab) monotherapy for cervical cancer will be stopped early. Read More
Gilead Sciences and Merck, rivals in the HIV space, have agreed to jointly develop two long-acting experimental HIV treatments into a two-drug regimen to be taken every few months. Read More
Additional phase 2 trial data for Eli Lilly’s Alzheimer’s drug candidate donanemab showed that the monoclonal antibody helped to significantly slow cognitive and functional decline and clear amyloid plaques in patients. Read More
Moderna announced that it has dosed the first participants in its phase 1 trial of mRNA-1283, its “next generation” COVID-19 vaccine candidate that’s being developed to have more relaxed temperature requirements for easier distribution and administration. Read More
Moderna said participants will receive either a booster targeted at the South African variant or the company’s new multivalent vaccine candidate. Read More
Sanofi Pasteur and Translate Bio are working together on a COVID-19 vaccine candidate that uses messenger-RNA (mRNA) technology and should be easier to store than Moderna’s and Pfizer/ BioNTech’s mRNA-based vaccines. Read More
Novavax said its COVID-19 vaccine demonstrated 96.4 percent efficacy against mild, moderate and severe forms of the original SARS-CoV-2 strain in the final analysis from its phase 3 UK trial. Read More