The latest global regulatory news, changes and updates affecting biopharma, including: Pandemic not the time for trade restrictions; Longer-term vaccine follow-up crucial; Labeling update advised for chloroquines; FDA stands up new DDT path; FDA drafts DDI guidance; MHRA continues Brexit updates; FDA debars three.
Two major papers on repurposed drugs for COVID-19 by researchers from Brigham and Women’s Hospital face intense skepticism from the research community, prompting the editorial boards of TheNew England Journal of Medicine and The Lancet to publish Expressions of Concern on the validity of the underlying data. Such expressions are often the first step toward an outright retraction.
LONDON – Companies represented in the expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines have signed a pledge to strengthen collaboration and sharing of data.
The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.