(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Search results for: psoriasis

Rheumatology Drug Updates on Brentuximab Vedotin, Tofacitinib Citrate
Brentuximab Vedotin Enters Phase 2 Trials Brentuximab vedotin (Adcetris), an antibody-drug conjugate (ADC) directed at CD30, is currently entering Phase 2 clinical trials for treating systemic lupus erythematosus (SLE).1 The ADC encompasses an anti-CD30 monoclonal antibody, which is attached by a protease-cleavable linker to a microtubule-disrupting agent, known as monomethyl auristatin E (MMAE). The ADC…
J&J’s Stelara Succeeds in Phase 3 Crohn’s Disease Trial
(Reuters)—Johnson & Johnson’s Stelara (ustekinumab) was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn’s disease, according to data from a late stage trial, providing ammunition for a potential expanded approval of the medicine. Stelara, a biotech medicine that blocks inflammation, is approved to treat plaque psoriasis…
Adalimumab, Tacrolimus Effective for Treating Refractory Ulcerative Colitis
NEW YORK (Reuters Health)—The human IgG1 anti-TNF antibody adalimumab is safe and effective for short- and long-term treatment, and the calcineurin inhibitor tacrolimus given short-term brings remission, in patients with refractory ulcerative colitis, according to two new studies in the Journal of Crohn’s and Colitis. In the first study, online Sept. 21, Dr. Tamas Molnar…
FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz
(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…

Arthritis Power App Can Help Patients Monitor Symptoms, Improve Office Visits
For the past 16 years, the website, creakyjoints.org, founded by arthritis patient Seth Ginsberg and social entrepreneur Louis Tharp, has offered arthritis patients and their families a safe online community where they can receive meaningful support and education. In March, the online portal added a new initiative—Arthritis Power, the first-ever patient-led, patient-generated, app-based research registry…

FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning
The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…

Rheumatologists Share Research, Successes at Annual Investigators’ Meeting
“Each project adds new knowledge that brings us a little closer to the cure,” Joan Bathon, MD, of Columbia University Medical Center, says of the Rheumatology Research Foundation’s 8th Annual Investigators’ Meeting in San Diego. Dr. Bathon was one of more than 30 investigators who presented the latest progress on research funded by the Foundation’s…

Phase 3 Trials: Secukinumab for Psoriatic Arthritis & DA-DKP for OA
In a global Phase 3 trial, subcutaneous secukinumab proved safe and effective in patients with psoriatic arthritis. Also, a version of aspartyl-alanyl diketopiperazine, a biologic for knee OA, has entered Phase 3 trials…

Ustekinumab Can Be Used to Safely Treat Teens & More
A recent study showed ustekinumab can be used to treat teens with moderate to severe psoriasis. Also, Phase 2 trials for an analgesic combination drug show it holds promise for reducing post-operative pain…
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