Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…
(Reuters Health)—Doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids, a new study found. The launch of drug-monitoring programs in 24 states led to an immediate 30 percent drop in prescriptions for Schedule II opioids, the most addictive, in patients with pain complaints, the study showed….
(Reuters)—The U.S. Food and Drug Administration said on Thursday it, along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers. The move is part of a global effort being led by the INTERPOL, the world’s largest police organization, to identify the…
NEW YORK (Reuters Health)—Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective, but underused, in patients with early axial spondyloarthritis, researchers from France report. NSAIDs are the cornerstone of treatment of axial spondyloarthritis, but there is often a trade-off between prescribing doses high enough to decrease pain and other symptoms vs. keeping the doses low enough to decrease…
NEW YORK (Reuters Health)—The anti-tumor necrosis factor (TNF) antibody adalimumab drives regulatory T cell (Treg) expansion in rheumatoid arthritis (RA) by binding to membrane TNF, researchers from the UK report. “These results show that adalimumab enhances the anti-inflammatory actions of TNF to increase regulatory T cell activity,” Dr. Michael R. Ehrenstein from University College London,…
NEW YORK (Reuters Health)—Aggregated results from three studies of patients with moderate to severe plaque psoriasis show that Eli Lilly’s injectable drug ixekizumab can completely resolve the plaques in about one third of cases after 12 weeks of treatment. And with continued therapy every four weeks, at least half maintained or attained complete resolution of…
In a clinical trial, patients with osteoarthritis taking low-dose SoluMatrix meloxicam used less rescue medication to manage pain. Also, the FDA has issued a new warning against using oral ketoconazole off label to treat onychomycosis and fungal skin infections…
(Reuters)—A U.S. Food and Drug Administration (FDA) advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties. The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have…
(Reuters Health)—The safety and effectiveness of cancer immunotherapy is largely unknown in patients with autoimmune diseases, researchers say—and that might account for up to a quarter of individuals with lung cancer. Patients with autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis or psoriasis, have been mostly excluded from clinical trials testing immunotherapies over fears that…
MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…