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The FDA released Q&A guidance yesterday on bioequivalence (BE) studies for generic drugs and abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read More
The U.S. government has stepped in to address a serious manufacturing error at Emergent BioSolutions’ Baltimore, Md., facility that wasted 15 million Johnson & Johnson (J&J) vaccine doses. However, putting J&J in charge of the site and barring production of AstraZeneca (AZ)’s vaccine there isn’t likely to halt AZ’s production schedule, a White House official said Monday. Read More
The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring. Read More
The study is currently enrolling individuals in the UK and Spain, with enrollment occurring soon in the U.S., Canada and the Netherlands, followed by Brazil and Argentina. Read More
Johnson & Johnson (J&J) said it is closely monitoring day-to-day operations at its COVID-19 vaccine subcontractor Emergent BioSolutions after a production error at the company’s Baltimore, Md., plant contaminated up to 15 million doses. Read More
Pfizer and BioNTech have accrued the data necessary to submit a biologics license application (BLA) for their COVID-19 vaccine and are seeking full approval as soon as this month, following a recent analysis from their phase 3 trial showing the vaccine held 91.3 percent efficacy up to six months after the second dose. Read More
The European Medicines Agency (EMA) confirmed yesterday that it has not found any causal link between blood clots and inoculation with the AstraZeneca (AZ) COVID-19 vaccine. Read More
With Pfizer/BioNTech’s COVID-19 vaccine demonstrating 100 percent efficacy in patients aged 12 to 15 years in their phase 3 trial, the companies will seek an amendment to their Emergency Use Authorization (EUA) and other regulatory authorizations to allow its use in that age group. Read More