The U.S. Food and Drug Administration (FDA), not the clinical sponsor, paused a recent study based on serious quality control issues at a production facility of Eli Lilly and Co. Apparently, this plant represented one of the facilities the company was preparing to utilize to ramp up production of the monoclonal antibody-based product touted by POTUS as “a cure” for COVID-19 based on government documents and three sources familiar with the issue reports Reuters. Both Lilly and Regeneron have invested heavily alongside support from the U.S. government in advanced monoclonal antibodies targeting SARS-CoV-2, the virus behind the pandemic.
According to a Reuters findings by the FDA, not previously disclosed despite the fact that Lilly has submitted an emergency use authorization (EUA), may complicate the pharmaceutical company’s effort to secure any authorization. The news agency cites two internal sources and outside legal experts. After all, U.S. law does preclude approvals if regulatory compliance measures are not up to standard. Reuters is talking to individuals that are concerned about retaliation and hence requested anonymity.
Apparently, the issue centers...
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