It’s estimated that a majority of patients with rheumatoid arthritis (RA) have been exposed to biologic treatments. However, the randomized controlled trials demonstrating the safety and efficacy of these biologic agents have strict participant eligibility requirements. New research has examined the requirements of 30 trials for biologics and applied those standards to two large clinical cohorts. The result: A majority of these RA patients did not satisfy the criteria…
Adalimumab-atto, Biosimilar to Humira, Receives FDA Approval
Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…
FDA Approves Ustekinumab for Crohn’s Disease
(Reuters)—Johnson & Johnson says on Monday that the U.S. Food and Drug Administration approved the company’s psoriasis drug, ustekinumab (Stelara), for use in adults with Crohn’s disease. The drug is approved in the U.S. to treat plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s is a chronic inflammatory condition in the gastrointestinal…
FDA Approves Adalimumab-atto, a Biosimilar of Humira
WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira). The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved…
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
U.S. Justice Department to Push Prosecutors on Opioids
WASHINGTON (Reuters)—The U.S. Justice Department will enlist federal prosecutors to help fight the nation’s opioid crisis by sharing information on overprescribing doctors and coordinating with public health officials to address addiction, USA Today reported on Friday. “You can’t just have an enforcement strategy alone,” Attorney General Loretta Lynch told the newspaper in an interview. She…
Abaloparatide Promising for Osteoporosis; NICE Draft Guidelines Include Secukinumab for Ankylosing Spondylitis
In a clinical trial, subcutaneous abaloparatide has proved effective in treating postmenopausal women with osteoporosis. Also in the U.K., draft guidelines for treating ankylosing spondylitis will recommend the use of secukinumab…
Express Scripts Tries to Rein in Pricey Inflammatory Drugs
NEW YORK (Reuters)—Express Scripts Holding, the largest manager of U.S. drug benefits, on Thursday launched a program aimed at tightening spending on drugs for pricey inflammatory conditions such as rheumatoid arthritis. It is the latest Express Scripts effort intended to reduce spending on prescription drugs, such as last week’s announcement of a diabetes program. Early…
Research on Ixekizumab in Psoriatic Arthritis and More Presented at EULAR 2016
LONDON—Results from the extension phase of a Phase 3 trial for the IL-17A inhibitor ixekizumab in psoriatic arthritis (PsA) show that patients started on placebo, adalimumab and ixekizumab continued to show improvements in arthritis, dactylitis and ethesitis, said Philip Mease, MD, a rheumatologist at Swedish Medical Center University of Washington in Seattle.1 Dr. Mease presented the…
Rheumatology Drug Updates: Ixekizumab Improves Work Productivity, plus Vobarilizumab Completes Phase 2 Trial in Rheumatoid Arthritis
Ixekizumab Improves Work Productivity in Patients with Plaque Psoriasis Indirect costs of reduced work productivity can have a significant impact on a patient’s quality of life. A recent article published in JAMA Dermatology analyzed the results of three multicenter, randomized double-blind Phase 3 trials, UNCOVER-1, UNCOVER-2 and UNCOVER-3, which evaluated the effect of ixekizumab on…
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