Spanish Biotechs Join Battle Against COVID-19
Clinical Trials, Plasma Collections and Test Kits
Spain has suffered more than most from COVID-19 but the life sciences sector is exploring a variety of ways to tackle the coronavirus pandemic.
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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.
Pivot from individual- to multi-patient protocols for expanded access may help generate data to inform regulatory filings and even payer determinations for Gilead’s potential COVID-19 treatment.
Kicking a rapid response mechanism into full gear, China approves Roche’s Actemra as a new treatment for coronavirus along with a flurry of testing kits.