SAN FRANCISCO—A 40-year-old woman shows up in the clinic with scarring alopecia, with an area of hyperpigmentation on the rim of her scalp, extending from just behind the temple to behind her ears. An examination with a dermatoscope shows hyperkeratotic follicular plugging. The case—in this example, the discoid form of cutaneous lupus erythematosus (DLE)—is one…
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Case Study in Dermatology: Tender Papules on Elbows, Hands in RA
The Case A 41-year-old woman was referred to the dermatology clinic for a three-month history of tender lesions on her elbows and around the joints of her hands. Her medical history was notable for seropositive, non-erosive rheumatoid arthritis (RA), which was being treated with 5 mg prednisone daily, 10 mg methotrexate weekly by mouth, 200…
Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused
Biosimilars Receive Positive News On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…
3 Clinical Trials Examine Sirukumab for RA; Plus TNF-α Combination & Monotherapies Are Compared for Treating PsA
Three clinical trials are evaluating subcutaneous sirukumab for safety and efficacy in treating rheumatoid arthritis. And a study found no significant difference in persistence and remission for TNF-α monotherapy when compared with TNF-α plus conventional DMARD combination therapy for treating psoriatic arthritis…
Opioid Investigated to Treat Acute & Chronic OA Pain; Plus New RA Treatment & More
In Phase 2 trials, the oral opioid, CR845, has proved promising in treating pain in patients with hip and knee osteoarthritis. Olokizumab is being investigated to treat RA, and in Canada, adalimumab has been approved to treat polyarticular JIA in 2–4 year-olds…
U.S. Patent Office Rules Against Amgen Humira Challenge
(Reuters)—U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira (adalimumab), a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine. In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that…
Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.
In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…
Biologic DMARDs Prove Effective for Psoriatic Arthritis & Combination DMARDs Show Promise for RA
In clinical trials, ixekizumab and adalimumab proved safe and effective in treating adults with active psoriatic arthritis. Also, the combination therapy of certolizumab pegol plus methotrexate was more effective than placebo for treating severe RA…
Amgen Files for U.S. Approval of Biosimilar
(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…
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