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…
Adalimumab Remains Safe, Effective for Psoriasis
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…
FDA Issues Stronger NSAIDs Warning
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…
Some Placebos More Effective Than Others in Osteoarthritis
NEW YORK (Reuters Health)—Some placebos are more effective than others, and these differences can influence the apparent outcomes of clinical trials, according to a systematic review and meta-analysis of osteoarthritis trials. “More surprising than the fact that all placebos are not equal is the magnitude of that difference,” Dr. Raveendhara R. Bannuru, from Tufts Medical…
Some Serious Drug Side Effects Not Reported to FDA Within 15 days
(Reuters Health)—Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds. Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths…
Evidence Lacking for Tests for Psoriasis Patients Using Biologic Agents
NEW YORK (Reuters Health)—Various organizations recommend dozens of screening and monitoring tests for patients with psoriasis or psoriatic arthritis who are using systemic biologic agents, despite sparse evidence to support any of them. “At a population level, these medications have proven to be very safe and the evidence does not support such extensive and frequent…
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