FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
|Articles|August 9, 2021
Emergent Approved to Export Vaccines in Latest COVID-19 Update
Author(s)BioPharm International Editors
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
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On August 6th, 2021, FDA released an update on various matters related to COVID-19. Among these topics was an update on Emergent BioSolutions, a manufacturer who has come under fire for their mishandling production of COVID-19 vaccines.
However, FDA has now approved certain lots of the AstraZeneca vaccine made at the facility suitable for export. While the AstraZeneca vaccine is not approved for use within the United States, it is used by various countries overseas.
Emergent’s Baltimore facility
On April 16th, 2021, FDA requested a
According to FDA, these vaccine lots were thoroughly tested for quality. The decision was made with the understanding of the global emergency being caused by COVID-19 and its variants.
FDA did not disclose what number of vaccines were eligible for export in their update.
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