My dear electronic health records How do I dislike thee? Let me count the ways Adaptation of Sonnet 43 By Elizabeth Barrett Browning, 1806–1861 As my tenure as physician editor winds down, it’s worth reviewing some of the more nettlesome issues confronting clinicians that have been previously discussed in these pages and gauge their current…
(Reuters)—A U.S. judge invalidated patents on Allergan Plc’.s dry eye medicine Restasis on the grounds that the patents cover obvious ideas, a decision that drove the pharmaceutical company’s shares down more than 6%. Judge William Bryson issued the ruling in federal court in Marshall, Texas, in a longstanding dispute between Allergan and generic drugmakers led…
As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…
MADRID—Scores on the Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ) and C-reactive protein (CRP) levels were independent predictors of whether patients could be tapered successfully from a TNF inhibitor after having reached remission of their RA, according to findings presented in a session at the Annual European Congress of Rheumatology. Researchers also developed a composite…
MADRID—The anti-IL6 “nanobody,” vobarilizumab, produced mixed results when used with methotrexate (MTX) and compared with MTX and placebo, according to results of a 24-week, double-blind Phase 2b study of patients with rheumatoid arthritis (RA), which were presented in an abstract session at the Annual European Congress of Rheumatology (EULAR). The drug missed its primary endpoint…
Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…
Romosozumab’s Future Is Uncertain Romosozumab, which has the possible U.S. brand name Evenity, is awaiting approval from the FDA.1 The treatment is an investigational, injectable biologic for treating osteoporosis. It increases bone formation and bone density, reducing a patient’s risk of fractures. The manufacturer no longer expects the FDA to approve the drug this year…
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
While members of Congress debate healthcare legislation, rheumatologists say many of their patients struggle to afford everything from generic drugs to insurance copayments for physical therapy. “It’s a mess. The cost of prescriptions and the rationale for those rising costs in the U.S. right now—it’s just a mess,” says James R. O’Dell, MD, Stokes-Shackleford Professor of…
Ipilimumab (Yervoy) is a monoclonal antibody directed against cytotoxic T-lymphocyte antigen 4 (CTLA-4). It was the first drug to demonstrate a survival benefit in advanced melanoma and was approved by the FDA in 2011.1 By blocking the CTLA-4 receptor, ipilimumab enhances the immune response against tumors via cytotoxic T lymphocyte activation and proliferation.2 However, immunopotentiating…