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Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

FDA Considers Tanezumab Application for Chronic OA Pain

Michele B. Kaufman, PharmD, BCGP  |  April 20, 2020

The FDA is considering an application for subcutaneous tanezumab, a monoclonal antibody, as a treatment for moderate to severe osteoarthritis…

Yes, the FDA Employs Rheumatologists. Here’s Their Role.

Renée Bacher  |  April 15, 2020

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…

FDA Approves Meloxicam Injection & OTC Diclofenac Sodium Topical Gel for Pain Management

Michele B. Kaufman, PharmD, BCGP  |  April 13, 2020

The FDA has approved two pain medications: meloxicam in an injection and over-the-counter diclofenac sodium topical gel 1%…

Data on Arthritis Drug to Treat Coronavirus Could Come within Weeks

Michael Erman & Axel Threlfall  |  April 10, 2020

(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…

Tocilizumab Begins Clinical Trial for COVID-19

Michele B. Kaufman, PharmD, BCGP  |  April 7, 2020

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…

Sanofi Can Produce Millions of Doses of HCQ, Potential Coronavirus Drug

Matthias Blamont & Michael Erman  |  April 3, 2020

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…

U.S. FDA Says HCQ & Other Malaria Drugs in Shortage as COVID-19 Drives Up Demand

Reuters Staff  |  April 1, 2020

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…

Sanofi, Regeneron Expand Testing of Potential Coronavirus Treatment

Reuters Staff  |  March 31, 2020

(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…

Rheumatology in the Age of COVID-19: HCQ Shortages Driven by Small, Nonrandomized Study

Michael Putman, MD  |  March 28, 2020

No data exist for prescribing hydroxychloroquine for post-exposure prophylaxis, and we should not prescribe it for this indication.

Old Drug, New Interest: COVID-19 Spurs Hydroxychloroquine Supply Concerns for Rheumatic Disease Patients

Susan Bernstein  |  March 27, 2020

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…

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