NEW YORK (Reuters Health)—Adverse drug events (ADEs) are more common when drugs are used off label, especially when the off-label use lacks strong scientific evidence, researchers from Canada report. “Our study demonstrated that physicians need to be cautious in prescribing off-label when there is a lack of strong scientific evidence for the use of the…
Signatures to Be Filed for California Drug Price Referendum
SACRAMENTO, Calif. (Reuters)—Backers of a referendum aimed at reducing the cost of prescription drugs in California said Wednesday that they had gathered more than enough signatures to place their measure on the November 2016 ballot in the most populous U.S. state. The measure by the AIDS Healthcare Foundation would require the state to pay no…
Don’t Bank on U.S. Drug Price Rises, Warns GSK Boss
LONDON (Reuters)—Pharmaceutical companies cannot depend on ever increasing prices in the U.S. and will need to find a new balance between incentives for innovation and access to medicines, according to the chief executive of GlaxoSmithKline. High drug prices have come under fierce political fire recently in America, the industry’s biggest and most profitable market, with…
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…
FDA Reviewers Question Safety of AstraZeneca’s Gout Drug
(Reuters)—The U.S. Food and Drug Administration staff reviewers have raised concerns about kidney- and heart-related side effects noted in trials on AstraZeneca Plc’s gout treatment, especially at higher doses. FDA reviewers, in a preliminary review published on Wednesday, expressed concerns over higher death rates related to the side effects in patients who took the drug,…
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…
FDA Warns ‘Don’t Use Tramadol in Children’ & More
New studies show ABT-494 is an effective alternative to anti-TNF alpha agents, as well as methotrexate, for RA. Also, the FDA issued a warning against using tramadol for young patients due to their increased risk of respiratory side effects…
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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