Coronavirus Notebook: Fauci Calls For Restraint In Disclosing Early Data; Bipartisan Lawmakers Want Warp Speed Audit
Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.
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In an open letter to the biopharmaceutical industry, BIO lays out principles for conducting COVID-19 clinical trials and disclosing and using the data. Senator Durbin asks eight vaccine makers backed by Operation Warp Speed how they will withstand political pressure to speed up the approval process.
Companies are shielded from antitrust concerns by Justice Department as they jointly prepare to manufacture whichever monoclonal-antibody-based coronavirus therapies emerge from development.
Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.