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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The Madrid-based group's Aplidin is set to go back yet again to European regulators but the sea squirt-derived drug seems to be showing more potential in COVID-19 than in multiple myeloma.
PharmaMar’s persistence has paid off in its fight to overturn the European Commission’s rejection of its marketing application for the multiple myeloma drug, Aplidin.
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.