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Emergent BioSolutions Inc.

www.emergentbiosolutions.com

Latest From Emergent BioSolutions Inc.

Takeda, CSL, Other Blood Plasma Firms Team On Hyperimmune COVID-19 Therapy

Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.

Coronavirus COVID-19 Deals

COVID-19 Vaccines: Ex-FDA Leaders Urge High Bar For Emergency Use Authorization

Eschewing the standard approval mechanisms for COVID-19 vaccines is likely only appropriate in very limited high-risk populations, unless clinical efficacy outcomes are available, former FDA leaders say.

Coronavirus COVID-19 Vaccines

US FDA To Exercise ‘Maximum Regulatory Flexibility’ For COVID-19 Plasma-Derived Therapeutics

Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.

Coronavirus COVID-19 Biologics

Coronavirus Vaccine: How Hard Might Development Get? Look At Chikungunya

Epidemiology complicates field efficacy trials, but US FDA advisory committee members regretfully agree that data from non-human primate passive transfer studies is compelling but potentially insufficient for chikungunya vaccines.

Coronavirus COVID-19 Drug Approval Standards
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