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.
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
The issue of the U.S. federal government’s response to the COVID-19 pandemic was revisited yet again in a hearing in the House of Representatives. While partisanship was on full display, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” about the prospects for a vaccine and that the development of candidates has not compromised scientific principles.
LONDON – In the first major breakthrough in therapeutics for COVID-19 infection, dexamethasone has been shown to have a statistically significant impact on mortality in the most seriously ill patients.
Just 80 days after first issuing an emergency use authorization (EUA) for oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) in treating COVID-19, the FDA is revoking that authorization in light of clinical data and scientific literature that raised questions about whether benefits of the treatment outweigh the risks.
LONDON – After all the controversy and a huge dose of hype, there is no clinical benefit from the use of hydroxychloroquine in patients admitted to the hospital with COVID-19, according to headline data from a large randomized trial of potential drugs for the infection currently running in the U.K.
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 - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.