WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
Ustekinumab Found to Be Effective in Adolescents with Psoriasis
NEW YORK (Reuters Health)—Adolescents with moderate to severe psoriasis may respond to the human monoclonal antibody ustekinumab as well as adults, with no unexpected side effects, a new study found. The findings are exciting in part because patients in this age group have limited treatment options, the study’s lead author Dr. Ian Landells, of Memorial…
FDA Issues Boxed Warning for Hydroxyurea & Neutropenia May Occur after Rituximab Treatments
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…
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