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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
The University of Oxford is gearing up to launch a trial of the anti-inflammatory drug adalimumab as a treatment for COVID-19 patients in community care homes. Read More
Regeneron Pharmaceuticals yesterday unveiled early data on its COVID-19 antibody cocktail in which the drug appeared to provide a benefit for nonhospitalized COVID-19 patients. Read More
GlaxoSmithKline (GSK) has launched a phase 2 trial in the UK of its investigational rheumatoid arthritis treatment otilimab for hospitalized COVID-19 patients. Read More