The FDA has issued a new boxed warning for Droxia (hydroxyurea). Also, according to a new study, RA patients receiving rituximab should be monitored for late-onset neutropenia…
Epratuzumab Results Disappointing, but Adalimumab Promising
Two Phase 3 trials have shown that epratuzumab did not meet its primary endpoints for treating SLE. Meanwhile, a Phase 3 study has shown adalimumab is effective for treating enthesitis-related arthritis in juveniles…
Biosimilar Drugs for RA Studied in Multiple Trials
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…
Similar RA Outcomes with Abatacept & Tocilizumab
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….
GSK Shuts U.S. Plant Due to Bacteria
(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…
FDA Investigates MRI Safety after Studies Find GBCA Deposits in Brain
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…
China Gets Tougher for Western Drugmakers
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…
Brentuximab Vedotin Enters Phase 2 Trials & More
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…
New Analysis Underscores Improving Pharma R&D Productivity
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…
Skin Complications of Anti-TNF Therapy Common in IBD
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…
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