WASHINGTON (Reuters)—The U.S. House of Representatives on Friday passed a bill aimed at speeding new drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it. The House voted 344 to 77 in favor of the bill, known as the 21st Century Cures Act, which would require the FDA to streamline the…
Phase 3 Studies Evaluate Lesinurad for Gout Treatment
For 12 months, two studies examined the use of lesinurad in combination with allopurinol to treat gout, with patients achieving reduced serum uric acid levels and demonstrating no severe toxicity.
FDA Strengthens Warning Label for Certain Antiinflammatory Drugs
(Reuters)—The U.S. Food and Drug Administration is strengthening an existing warning label that non-aspirin, non-steroidal antiinflammatory drugs (NSAIDs) increase the risk of heart attack or stroke. NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib, all of which carry FDA warning labels. The agency said it would require updates to the labels of prescription and over-the-counter (OTC)…
The ACR’s State-of-the-Art Clinical Symposium: Experts Discuss Jakinibs, Osteoarthritis, Membranous Lupus Nephritis
CHICAGO—With the approval of the Jak inhibitors (i.e., jakinibs) tofacitinib and ruxolitinib—and others being investigated—rheumatologists need to arm themselves with an understanding of these drugs so they can think critically when evaluating them and deciding how to use them, said John O’Shea, MD, chief of the Molecular Immunology and Inflammation Branch of and scientific director…
Adverse Event Risk Data Drive Evaluation of Psoriasis Treatments
PSOLAR, the Psoriasis Longitudinal Assessment and Registry, is a multicenter, longitudinal, intercontinental, disease-based registry used to identify adverse events from commonly used psoriasis drugs.1 An evaluation of the risk of serious infection from systemic psoriasis treatments was recently published using data from PSOLAR. Ninety-three institutional review boards or ethics committees reported into the registry from…
Rontalizumab May Help Patients with Lupus & Low Interferon Signature
In a Phase 2 study, researchers found that rontalizumab was a more effective treatment in patients with systemic lupus erythematosus who had an interferon signature metric score lower than 1.
Studies Challenge Conventional Infliximab Protocols in IBD
NEW YORK (Reuters Health)—Dose optimization of infliximab is needed much earlier in ulcerative colitis than in Crohn’s disease, a single-center retrospective study reveals. “We compared the rates of dose increases over a fairly lengthy period of time,” said Dr. Mark Silverberg, the study’s senior author from the Mount Sinai Hospital in Toronto. “Patients with ulcerative…
Personal Beliefs Affect Medication Adherence for RA Patients
A recent British study concluded that determining a rheumatoid arthritis patient’s personal beliefs about medication could aid rheumatologists in regularly addressing medication adherence during visits.
Second Indian Firm Under Fire for Shoddy Clinical Drug Trials
LONDON/MUMBAI (Reuters)—Another Indian clinical research organization, Quest Life Sciences of Chennai, is in trouble over defective trials work, according to a warning issued by the World Health Organization. The action by the United Nations health agency follows an earlier scandal over drug testing at GVK Biosciences, which resulted in approvals for hundreds of generic drugs…
Biosimilar Drug Updates Reported from EULAR
At the 2015 meeting of the European League Against Rheumatism in June, multiple studies were presented comparing the use of different biosimilar and biologic drugs in treating rheumatoid arthritis…
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