Search results for "Covid"
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
COVID has changed a lot, and there's been a lot of different COVID guidance from the FDA.
Another thing to look at is from the cell and gene therapy area. FDA has issued a lot of guidance earli…
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Report from the 12th Plasma Product Biotechnology Forum
After a prolonged break due to the Covid-19 pandemic, there was a great appetite to meet again and discuss the latest developments of importance to the industry. The 12th PPB conference, held in Novem…
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The Pulse on the Industry - BioPlan and the Biopharma Resilience Index
This podcast is an informative and accessible discussion on the biopharma industry’s needs and possible solutions being taken to address these issues.
LISTEN TO THE PODCAST >
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Pandemic Alters Policies and Practices for Drug Development and Regulation
The desperate need for new vaccines and therapies to tame the deadly COVID-19 virus required new policies and procedures for how biopharma companies select, test, and manufacture medical products—and …
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Maximum Output Starts with Optimized Upstream Processing
…s, and cell, gene, and gene-editing therapies—was occurring worldwide before the emergence of the COVID-19 pandemic. Demand for biosimilars is also increasing. The requirements associated with COVID-…
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Novavax Reports on Two Vaccine Efficacy Studies
Novavax announced on June 14, 2021, results from two studies of is recombinant nanoparticle protein-based COVID-19 vaccine; in a large study, the vaccine candidate demonstrated 90.4% efficacy overall …