The FDA has approved a single-press, self-injection device for a 100-mg dose of guselkumab for adults with moderate to severe plaque psoriasis…
Biosimilars: How Do They Affect Patient Care & Safety?
CHICAGO—“We have got to get over this hump. We have got to try new stuff,” said Jacqueline M. Fritz, RN, MSN, CNS, to the audience gathered on the final day of the 2018 ACR/ARHP Annual Meeting, referring to the subject of biosimilars. Ms. Fritz, the owner and coordinator of education at the Medical Advancement Center…
FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
The FDA has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related and other death in RA patients…
Safety Risk with Higher Dose Tofacitnib
According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…
Tainted Research Repeatedly Re-Used to Assess Drug Effectiveness
(Reuters Health)—A new study shows how fake news—specifically, information about scientific research that may be tainted by fraud—keeps getting spread through the medical literature, misleading doctors about the safety and effectiveness of the drugs they prescribe. At issue is the failure of medical journals to flag research that’s been identified by the U.S. Food and…
Clinicians’ Use of ‘Safer’ Opioid-Prescribing Practices Spotty
NEW YORK (Reuters Health)—Many U.S. clinicians aren’t following risk-mitigation practices for opioid prescribing, new findings show. “In response to this national opioid crisis, consensus-based safer opioid prescribing guidelines have been published and state laws regulating opioid prescribing practices have been enacted,” Daniel P. Alford, MD, of Boston University School of Medicine, and colleagues write in…
Upadacitinib at the FDA
Upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor, which recently completed phase 3 clinical trials for treating patients with moderate to severe rheumatoid arthritis (RA). In late 2018, AbbVie Inc. submitted a New Drug Application to the U.S. Food and Drug Administration, as well as a marketing authorization application to the European Medicines Agency,…
U.S. Senators Tell Drug Company Execs Pricing Is Morally Repugnant
WASHINGTON/NEW YORK (Reuters)—U.S. Senators called drug pricing practices “morally repugnant” and told drug company executives they do not want to hear them blame others for the high prices, taking an aggressive stance at the start of a Senate hearing on the rising costs of prescription medicines. Executives from Abbvie Inc., AstraZeneca PLC., Sanofi SA, Pfizer…
Tanezumab for OA Pain
In a recent study, tanezumab proved more effective than placebo in treating patients with moderate to severe pain caused by hip or knee osteoarthritis…
Rheumatologists Debate Hydroxychloroquine Dosing Guidelines for Lupus
CHICAGO—The correct dosing of hydroxychloroquine (HCQ) for systemic lupus erythematosus (SLE) is a concern of all rheumatologists. Petros Efthimiou, MD, clinical professor of medicine at New York University, New York City, opened the Great Debate of the 2018 ACR/ARHP Annual Meeting by stating, “Today, we will be discussing a critical clinical problem that affects everyone’s…
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