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Regeneron has identified hundreds of coronavirus antibodies for developing treatments for COVID-19 and hopes to start clinical trials by early summer. Read More
The first U.S. clinical trial for a coronavirus vaccine got under way yesterday — a phase 1 trial of Moderna’s mRNA-1273 in collaboration with the National Institutes of Health. Read More
Former FDA Commissioner Scott Gottlieb said he believes a vaccine for COVID-19 — caused by a virus that could be “a once in a generation pathogen” — will take two years to become available for public use. Read More
Drugmakers spend an average of $1.3 billion in research and development costs to get a new medicine to market, according to a new study reported in JAMA this week, a number considerably lower than a 2016 Tufts report citing development costs of $2.8 billion. Read More
Four of eight complex trial designs submitted in the FDA’s complex innovative trial design (CID) pilot program have been accepted for review, the agency said Monday. Read More
Participation of women in clinical trials of drugs approved by the FDA increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, but ethnic diversity in trials overall remained steady, according to the agency’s latest Drug Trials Snapshot Summary Report. Read More
Nearly 600 pediatric drugs across various therapeutic areas are currently being tested in clinical trials, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Read More
Janssen Pharmaceuticals is joining forces with HHS to develop a vaccine candidate for COVID-19 and the Johnson and Johnson subsidiary is prepared to produce it on a large scale. Read More