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GlaxoSmithKline’s (GSK) and Vir Biotechnology’s monoclonal antibody sotrovimab has secured FDA Emergency Use Authorization (EUA) for treating mild-to-moderate COVID-19 in patients 12 years and older at high risk of progressing to severe disease. Read More
Sanofi and GlaxoSmithKline have begun enrolling participants in a global phase 3 trial of their COVID-19 vaccine candidate that could potentially lead to a regulatory approval in the fourth quarter of 2021. Read More
Belgian officials said the suspension would remain in effect “pending a more detailed benefit-risk analysis” by the European Medicines Agency. Read More
Moderna said its COVID-19 vaccine offered strong protection against infection in adolescents ages 12 to 17 years in a phase 2/3 study, paving the way for the company to seek a revised Emergency Use Authorization that covers this population. Read More
The FDA may decline to review COVID-19 vaccine Emergency Use Authorization (EUA) requests from drugmakers who neglect to meet with the agency during product development, the agency said in a revised guidance released yesterday. Read More
The FDA is reviewing Pfizer’s Biologics License Application for 20vPnC under a Priority Review designation and the agency’s decision is anticipated in June. Read More
In a declaration released Friday following the G20 Global Health Summit in Rome, world leaders called for voluntary patent licensing and technology transfers for COVID-19 vaccines and therapeutics. Read More
Vaccine supplies to poorer countries have been significantly impacted by the worsening COVID-19 crisis in India, a major supplier to those countries. Read More
The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More
Emergent BioSolutions CEO Robert Kramer said Wednesday that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year. Read More