Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…
NEW YORK (Reuters Health)—Clinical outcomes of rheumatoid arthritis (RA) are similar with abatacept and tocilizumab treatment, but the factors that predict efficacy differ for the two agents. “The recommendations for RA treatment from the U.S. and EU describe the use of abatacept and tocilizumab as first-line biologics along with anti-TNF (anti-tumor necrosis factor) inhibitors,” Dr….
(Reuters)—Drugmaker GlaxoSmithKline temporarily closed a North Carolina factory on Tuesday after testing at a cooling tower found bacteria that causes deadly Legionnaire’s disease. The Legionella bacteria were discovered during routine inspections at the site in Zebulon, N.C., the company said. The shutdown is not expected to disrupt supplies of medicines made at the factory, which…
The FDA is investigating the safety of MRIs using gadolinium-based contrast agents, which recent studies have shown may leave deposits of those chemicals in patients’ brain tissue after multiple scans…
LONDON (Reuters)—The Chinese market is getting tougher for Western pharmaceutical companies as Beijing bears down on a rising healthcare bill and prices come under pressure. The country, which has overtaken Japan as the world’s second largest market for prescription medicines after the U.S., has drawn major investment from global drugmakers in recent years — but…
Phase 2 clinical trials have begun to assess the safety of brentuximab vedotin for the treatment of SLE. Also, the FDA is reviewing an application for a once-daily tofacitinib citrate tablet to treat RA…
LONDON (Reuters)—Drug industry productivity is continuing to improve, with a bumper haul of new products being launched and companies proving more successful in the final stages of clinical testing, according to a new analysis. Data from Thomson Reuters published on Tuesday showed the number of innovative medicines, or new molecular entities, launched globally in 2014…
NEW YORK (Reuters Health)—Dermatologic complications hit about one in five patients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor (anti-TNF) therapy, leading to discontinuation of treatment, a French study finds. Dr. Laurent Peyrin-Biroulet, from University Hospital of Nancy, and colleagues note that dermatological complications of anti-TNF therapy are known to occur frequently in IBD…
NEW YORK (Reuters Health)—In adults with chronic plaque psoriasis, adalimumab (Humira, AbbVie) was generally well tolerated and effective during five years of therapy, according to a new analysis. The interim analysis is from ESPRIT, a 10-year multinational post-marketing registry. “Clinical trials are not the real world,” in part because patients with comorbidities are screened out…
The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction…