Search results for "Covid" in Articles / App Notes
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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.
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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 …