In multiple trials, baricitinib has proved promising for treating RA. Also, the FDA is requiring drug-interaction studies for sodium polystyrene sulfonate…
Zimmer Wins First U.S. Trial over NexGen Flex Knee Devices
(Reuters)—Indiana-based medical device manufacturer Zimmer Biomet Holdings Inc. on Friday was cleared of liability in the first of more than 900 U.S. lawsuits to go to trial over claims that its NexGen Flex knee replacements were prone to painful, motion-impairing loosening. Following a three-week trial in the U.S. District Court for the Northern District of…
Methotrexate Increases Risk of Recurrent Nonmelanoma Skin Cancer
NEW YORK (Reuters Health)—Methotrexate appears to increase the risk of recurrent nonmelanoma skin cancer (NMSC) in patients with rheumatoid arthritis (RA), according to a retrospective study. “We have known for some time that several of the immunosuppressive agents used to treat RA and inflammatory bowel disease (IBD) are also associated with an increased risk of…
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…
Adverse Events More Common with Off-Label Drug Use
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…
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