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GlaxoSmithKline (GSK) and Vir Biotechnology have begun enrolling participants in phase 3 trials to assess the safety and efficacy of their monoclonal antibody, VIR-7831, in treating COVID-19 infections early on in high-risk patients. Read More
The European Medicines Agency’s (EMA) safety committee has begun a review of acute kidney injuries reported in some COVID-19 patients being treated with Gilead Sciences’ remdesivir. Read More
President Trump is being treated with dexamethasone, remdesivir and Regeneron Pharmaceuticals’ investigational antibody cocktail in his battle against COVID-19, following his announcement Friday that he and the first lady had tested positive for the coronavirus. Read More
Pfizer will not allow political arm-twisting to speed up or delay its COVID-19 vaccine candidate trials, the company’s CEO Albert Bourla stressed in an open letter last week. Read More
Sponsors of opioid use disorder (OUD) treatments should expand their trials beyond collecting evidence for an NDA submission and gather data on additional clinically meaningful outcomes the FDA considers “highly valuable,” according to a final guidance the agency released last week. Read More
Two leading COVID-19 vaccine developers, AstraZeneca and Moderna, have hit new speed bumps that could delay their promising COVID-19 vaccine candidates, reducing the possibility of a vaccine being ready ahead of the U.S. presidential election on Nov. 3. Read More
Individuals over the age of 65 are likely to be excluded from more than 50 percent of trials studying COVID-19 therapies and 100 percent of COVID-19 vaccine trials, despite the fact that these older patients account for more than 80 percent of deaths related to the disease, according to a new study in JAMA Internal Medicine. Read More
The National Institute of Allergy and Infectious Diseases (NIAID) has stopped enrolling severely ill COVID-19 patients in a phase 3 trial of Merck’s Rebif (interferon beta-1a) with Gilead Sciences’ remdesivir because of serious adverse events. Read More