An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
A Phase I clinical trial has shown that Ad4-H5-VTN, a single-dose, intranasal influenza vaccine, was safe and produced an immune response.
The ITAC trial will establish if adding hyperimmune intravenous immunoglobulin (hIVIG) to a remdesivir regimen can improve hospitalised COVID-19 patient outcomes.
European Pharmaceutical Review explores some of the latest developments in outsourcing, including clinical development and production agreements; acquisitions and collaborations; and expansions.
The company announces it has been task ordered by BARDA to assist in the US government’s efforts to deliver COVID-19 vaccines.
A new report has revealed the vaccine R&D efforts of 15 of the leading pharmaceutical companies to combat the COVID-19 coronavirus.