Ever wonder what role physician regulators—rheumatologists, in particular—perform at the U.S. Food & Drug Administration (FDA)? “I am not sure that many practicing rheumatologists know there are clinicians who work for the FDA,” says rheumatologist Nadia Habal, MD, a medical officer in the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA. “It would…
(Reuters)—Initial data from clinical trials testing whether patients with severe coronavirus illness can be helped by a rheumatoid arthritis drug sold by Regeneron Pharmaceuticals Inc and Sanofi SA may come as early as next week, Regeneron’s chief scientific officer told Reuters. “We could be one to two weeks—at most a month or so—away from knowing…
The FDA has authorized a phase 3 clinical trial examining the safety and efficacy of tocilizumab plus standard care in patients hospitalized with COVID-19…
PARIS (Reuters)—Sanofi SA will be able to provide millions of doses of hydroxychloroquine (HCQ) for patients with the illness caused by the novel coronavirus if the old malaria drug proves successful in clinical trials, its chief executive tells Reuters on Thursday. Paul Hudson, who became CEO of the French drugmaker in September, said in an…
April 1 (Reuters)—The U.S. Food and Drug Administration (FDA) said malaria drugs hydroxychloroquine and related chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic. The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency’s website that lists…
(Reuters)—Sanofi and Regeneron Pharmaceuticals Inc. have expanded a clinical trial of their rheumatoid arthritis drug Kevzara (sarilumab) as a coronavirus treatment to patients outside the U.S. The companies said enrolments for the mid-to-late stage trial of sarilumab, an immune-system modifying drug known as a monoclonal antibody, have now started in Italy, Spain, Germany, France, Canada…
After a study investigated if hydroxycholoroquine (HCQ) benefits COVID-19 patients, the drug—used to treat SLE and RA patients—began running out in pharmacies around the U.S. ACR leaders have asked the FDA to increase monitoring of the HCQ supply…