Health regulators abroad have begun giving the OK for AstraZeneca to resume its phase 3 COVID-19 vaccine trial following a single unexplained patient illness, but the FDA has still not cleared the trial to start back up, with FDA Commissioner Stephen Hahn saying the agency will engage in “very significant work” with the company to unravel the safety issue. Read More
The CEOs of nine pharmaceutical companies racing to develop COVID-19 vaccines made an unprecedented pledge last week to “uphold the integrity of the scientific process” in the trials they are conducting for vaccine approval. Read More
AstraZeneca has paused a late-stage trial of its promising COVID-19 vaccine candidate while it evaluates a single UK patient who may have experienced a serious adverse reaction. Read More
Dwindling clinical trial financial resources caused by COVID-19 and declining investigator participation are clashing with sponsors’ demand for more — and more complex — trials, creating a “perfect storm” of pressure that threatens to overwhelm the research industry if sites and sponsors don’t work together to adjust to the realities of life in a pandemic. Read More
In an open letter by the Biotechnology Innovation Organization (BIO) published last week, a group of biotech CEOs argued that political considerations should be put aside by both major political parties and the conclusions about the safety and efficacy of COVID-19 therapies should only be based on rigorous data collection and assessment by appropriate bodies. Read More
The FDA has updated its guidance on the use of convalescent plasma to treat COVID-19 or in clinical trials of the treatment to take account of the Trump administration’s Aug. 23 Emergency Use Authorization (EUA). Read More
The FDA’s decision to grant Emergency Use Authorization (EUA) for convalescent plasma in patients with COVID-19 has led many investigators to voice concerns that not enough patients with the infection will enroll in randomized controlled trials of the therapy going forward. Read More
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