To understand the usual approval process followed by the FDA, researchers of the Yale University School of Medicine have systematically evaluated all novel vaccines approved by the FDA over the last decade, characterizing the premarket development and regulatory review times, the clinical evidenceon which approval was based, and the size and follow-up duration of the
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about
SARS-CoV-2 induced hypercytokinemia and inflammation are critically associated with COVID19 disease severity. Baricitinib, a clinically approved JAK1/2 inhibitor, is currently being investigated in COVID-19 clinical trials. In this paper published on Cell, are investigated the immunologic and virologic efficacy of baricitinib in a rhesus macaque model of SARS-CoV-2 infection. Viral shedding measured from nasal and
A National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with coronavirus disease 2019 (COVID-19) has formally concluded that the drug provides no clinical benefit to hospitalized patients. Though found not to cause harm, early findings in June when the trial was stopped indicated that the
Remdesivir is an antiviral medication that targets a range of viruses. It was originally developed over a decade ago to treat hepatitis C and a cold-like virus called respiratory syncytial virus (RSV). Remdesivir wasn’t an effective treatment for either disease. But it showed promise against other viruses. Researchers tested remdesivir in clinical trials during the
Scientists at University of Cambridge have used gene therapy to regenerate damaged nerve fibres in the eye, in a discovery that could aid the development of new treatments for glaucoma, one of the leading causes of blindness worldwide. Axons – nerve fibres – in the adult central nervous system (CNS) do not normally regenerate after
The brain is uniquely protected against invading bacteria and viruses, but its defence mechanism has long remained a mystery. Now, a study in mice, confirmed in human samples, has shown that the brain has a surprising ally in its protection: the gut. Source University of Cambridge The brain is arguably the most important organ in
Since June 2020, 214 human cases of COVID-19 have been identified in Denmark with SARS-CoV-2 variants associated with farmed minks, including 12 cases with a unique variant, reported on 5 November. All 12 cases were identified in September 2020 in North Jutland, Denmark. The cases ranged in age from 7 to 79 years, and eight
Investigations of deceased COVID-19 patients have shed light on possible lung damage caused by the virus. The study, published today in The Lancet’s eBioMedicine, by King’s in collaboration with University of Trieste and the International Centre for Genetic Engineering and Biology in Italy, shows the unique characteristics to the SARS-CoV-2 virus and may explain why
A new study reveals the virus triggers production of antibodies circulating through the blood, causing clots in people hospitalized with the disease. Blood clots continue to wreak havoc for patients with severe COVID-19 infection, and a new study explains what may spark them in up to half of patients. The culprit: an autoimmune antibody that’s
