NEW YORK (Reuters Health)—A new chikungunya virus-like-particle vaccine appears to be safe and immunogenic, according to results from a phase 2 trial. “The phase 2 safety, tolerability and immunogenicity were similar to the data seen in an earlier phase 1 study,” Grace L. Chen, MD, of the National Institutes of Health Vaccine Research Center, Bethesda,…
Articles by Natasha Yetman
FDA Cautions Slower Drug Review Activity Due to Staff Reallocation for COVID-19
(Reuters)—On April 16, the U.S. Food & Drug Administration (FDA) cautioned that with a lot of its staff allocated to the coronavirus crisis, it may not be able to sustain its current level of timely reviews and approvals of marketing applications. FDA says it was working to ensure that the drug programs continue to see…
Novartis to Test Efficacy of Old Malaria Drug Against COVID-19
ZURICH (Reuters)—Swiss drugmaker Novartis AG says it will test the malaria drug hydroxychloroquine (HCQ) in a randomized trial to see if the much talked about medicine is actually effective against COVID-19, the illness caused by the novel coronavirus. The company hopes to have data on its efficacy by June, a lead researcher for the trial…
Data on Arthritis Drug to Treat Coronavirus Could Come within Weeks
(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…
Amneal Running Out of HCQ Raw Material Due to Finnish Restrictions
NEW YORK/HELSINKI (Reuters)—Amneal Pharmaceuticals could soon run out of the raw ingredients to make more of the anti-malarial drug hydroxychloroquine (HCQ) that has been touted as a potential treatment for COVID-19 because Finland is keeping the drug for domestic use, according to the generic drugmaker’s chief executives. Amneal has committed to producing about 20 million…
Cortisone Shots Less Effective Than PT for Arthritis-Related Knee Pain
(Reuters Health)—People with stiff and aching knees due to arthritis get better relief from physical therapy than from cortisone injections, according to a one-year military study comparing the two treatments. A multi-disciplinary team of doctors reports in The New England Journal of Medicine that people who initially scored 107 on a 241-point scale measuring a…
FDA Accelerates Approvals of Generic Versions of HCQ
On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic…
Should Biologic Therapy in Dermatology Be Interrupted During the Pandemic?
NEW YORK (Reuters Health)—The ongoing novel coronavirus pandemic has raised concerns about whether biologic therapy could make psoriasis patients more susceptible to SARS-CoV-2, the virus behind COVID-19. Mark Lebwohl, MD, from Icahn School of Medicine at Mount Sinai Hospital in New York and colleagues address this issue in a letter in the Journal of the…
Sanofi Can Produce Millions of Doses of HCQ, Potential Coronavirus Drug
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
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…
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