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Public Rarely Knows Why FDA Rejects New Drugs

Lisa Rapaport  |  

(Reuters Health)—Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete…

Zoledronic Acid May Improve Bone Density in Elderly Women

Anne Harding (Reuters Health)  |  

A single injection daily of zoledronic acid may improve bone mineral density (BMD) in frail elderly women in long-term care facilities, a new randomized controlled trial shows. However, the clinical importance of the improvement, observed over a two-year period, remains unclear, Dr. Neil M. Resnick, of the University of Pittsburgh, told Reuters Health in a…

Ixekizumab Clinical Trials Continue; FDA Updates Warning Label for Varenicline

Michele B. Kaufman, PharmD, CGP, RPh  |  

It seems to have begun in Norway, the international pressure to switch patients from well-known brand biologic agents, such as Remicade (infliximab), to biosimilar agents, due to a significant cost advantage.1 This biosimilar came with a 39% price markdown last year compared with the brand, and when Norway called for bids, the discount went to…

Rheumatoid Arthritis, Periodontal Disease Link Suggests Benefits in Behavioral Change

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Although compelling data exist to support a link between periodontal disease (PD) and the development of rheumatoid arthritis (RA), cementing the association will require extensive investigative work.1 However, in reviewing the literature of the past 10 years, Elliot D. Rosenstein, MD, director, Institute for Rheumatic and Autoimmune Diseases at Overlook Medical Center, Summit, N.J., and…

Tips for Treating Insomnia in Rheumatology Patients

Linda Childers  |  

Chronic insomnia is a common complaint for patients with rheumatic diseases and conditions. In fact, sleep disturbances are among the most common symptoms of both fibromyalgia and rheumatoid arthritis (RA), with more than 50% of chronic pain patients reporting sleep disturbances. Pain combined with insomnia can lead to a vicious cycle, says Ruth Gentry, PhD,…

COPA Genetic Mutation Identified in Lung Disease, Arthritis

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Researchers from California and Texas have identified a new genetic syndrome that is characterized by systemic autoimmune disease of the lung and joints. The syndrome is driven by a genetic variant of a vesicular transport protein and is the first documented association between intracellular transport and autoimmunity. Levi B. Watkin, PhD, postdoctoral fellow at Baylor…

Disease Management Programs Help Patients Cope with Chronic Diseases

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For patients living with a chronic disease, such as rheumatoid arthritis or osteoarthritis, learning to manage and cope with the myriad adverse symptoms that accompany these diseases is key to improving quality of life and helping reduce the cost burden of these illnesses on the healthcare system. One important way rheumatologists can help is by…

Why Rheumatologist–Pulmonologist Collaboration Is Essential

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Although close collaboration with a variety of specialists outside of rheumatology is important, you could make the case for rheumatologists and pulmonologists having to work together even more closely. If lung symptoms are severe and not under control, the results could be fatal. However, the question sometimes is when to refer—even when there are not…

Institute of Medicine Recommends Changes in Graduate Medical Education

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Questions, concerns and spirited debate have surrounded the Graduate Medical Education (GME) system for decades. The program that trains nearly 120,000 physicians per year is under constant scrutiny.1 Changes to the political landscape, combined with ongoing efforts by health industry payers and regulators to squeeze inefficiency out of the system, have kept the GME in…