The US Justice Dept. is suing author Stephanie Winston Wolkoff over her book about her former friendship with first lady Melania Trump, saying she violated confidentiality.
paused its Covid-19 vaccine trial after a volunteer had an unexplained illness. J&J said the participant's condition was being reviewed and evaluated by the Data Safety Monitoring Board. It's unclear whether the volunteer who had an adverse event had received the actual vaccine or a placebo.It's not uncommon for late-stage trials to hit bumps, said Dr. Eric Topol, director of the Scripps Research Translational Institute in California.
Dr. Carlos del Rio, infectious diseases expert at Emory University School of Medicine, agreed."Pauses are not infrequent in a clinical trial, and in these studies, they are going to be probably a bit more frequent as the development line for a product is significantly truncated,” he said.Just last week, Lilly requested emergency use authorization from the Food and Drug Administration for the antibody treatment, using data from a separate clinical trial — not the trial that was just paused.
No published or peer-reviewed results have been released about the treatment, but last month the company released partial results from aof the drug, which suggested it could help keep patients with mild to moderate forms of the illness from progressing to a point where they would need to be hospitalized.
The paused trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. When the
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