Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval
The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…
Higher Tocilizumab Dose Plus Methotrexate Best for Early RA
NEW YORK (Reuters Health)—Tocilizumab improves remission rates and slows disease progression in patients with early rheumatoid arthritis (RA), a new randomized controlled trial demonstrates. Tocilizumab was effective both on its own and when combined with methotrexate, Dr. Gerd R. Burmester of Charite Medical University of Berlin and his colleagues found. Tocilizumab, an interleukin-6 (IL-6) blocker,…
RA Drug Tested & FDA Orders Drug-Interaction Studies for Kayexalate
In multiple trials, baricitinib has proved promising for treating RA. Also, the FDA is requiring drug-interaction studies for sodium polystyrene sulfonate…
German Registry Evaluates Systemic Psoriasis Treatments
The German Psoriasis Registry, PsoBest, found conventional systemic and biologic drugs for psoriasis demonstrated relative safety from serious adverse events in patients between January 2008–December 2012…
Tofacitinib on Hold for Psoriasis, Plus Anti-TNFs Top FDA List for Adverse Events
The FDA is asking for more safety analysis before approving tofacitinib to treat psoriasis. Also, adalimumab and etanercept received the greatest number of adverse and serious adverse events reported to the FDA in 2014…
J&J’s Stelara Succeeds in Phase 3 Crohn’s Disease Trial
(Reuters)—Johnson & Johnson’s Stelara (ustekinumab) was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn’s disease, according to data from a late stage trial, providing ammunition for a potential expanded approval of the medicine. Stelara, a biotech medicine that blocks inflammation, is approved to treat plaque psoriasis…
Rituximab May Benefit Patients with Refractory JIA-Associated Uveitis
NEW YORK (Reuters Health)—Rituximab may calm juvenile idiopathic arthritis (JIA)-associated uveitis and especially benefit patients who haven’t responded to other biologic treatments, a study from Italy suggests. With its convenient dosing schedule, rituximab may be a new treatment option for patients with autoimmune diseases, especially for those who have not responded to tumor necrosis factor…
Adalimumab, Tacrolimus Effective for Treating Refractory Ulcerative Colitis
NEW YORK (Reuters Health)—The human IgG1 anti-TNF antibody adalimumab is safe and effective for short- and long-term treatment, and the calcineurin inhibitor tacrolimus given short-term brings remission, in patients with refractory ulcerative colitis, according to two new studies in the Journal of Crohn’s and Colitis. In the first study, online Sept. 21, Dr. Tamas Molnar…
FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz
(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…
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