ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,…
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Affiliate Society Council Meeting Provides Motivation, Fellowship, Opportunity
On Wednesday, May 16, 2018, the ACR’s Affiliate Society Council (ASC) convened a meeting in Washington, D.C., in conjunction with the ACR’s Advocacy Leadership Conference. Despite inclement weather that delayed or cancelled numerous flights, several rheumatology representatives from states across the U.S. attended the meeting in person, while others participated by conference call. “It was…
FDA to Review Abuse-Deterrent Oxycodone Capsule
FDA to Review Abuse-Deterrent Oxycodone Capsule In June, the FDA will discuss the New Drug Application for Remoxy ER at an Advisory Committee meeting. Remoxy ER is a 12-hour, abuse-deterrent, extended-release oxycodone in a capsule formulation.1 The capsule contains a sticky, thick, high-viscosity formulation to deter unapproved drug administration routes, including injection, smoking or snorting….
International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…
Patients Lose When Insurance Company Forces Drug Switch
This past June, a 64-year-old man with a history of psoriatic arthritis and severe arthritis appeared at our clinic for his regular follow-up with concerns about a letter from his insurance company. The letter stated the company wouldn’t pay for the patient’s secukinumab (i.e., Cosentyx) prescription anymore and suggested he take ixekizumab (i.e., Taltz) instead,…
FDA to Review Abuse Deterrent Oxycodone Capsule & More
The FDA will discuss a New Drug Application for Remoxy ER during an upcoming advisory committee meeting and recently approved tildrakizumab-asmn to treat adults with plaque psoriasis…
The FDA Approved Several New Rheumatology Drugs in 2017
SAN DIEGO—In a session at the 2017 ACR/ARHP Annual Meeting, Kam Nola, PharmD, MS, professor in the College of Pharmacy and vice chair in the Department of Pharmacy Practice at Lipscomb University in Nashville, Tenn., updated participants on new medications and new indications for rheumatology treatments and safety labeling changes approved by the U.S. Food…
DMARDs & Biologics Info for Rheumatology Nurses
SAN DIEGO—In a presentation on what rheumatology nurses should know in their daily practice about disease-modifying anti-rheumatic drugs (DMARDs) at the 2017 ACR/ARHP Annual Meeting Nov. 3–8, Jessica Farrell, PharmD, highlighted the importance of educating and counseling patients about the range of treatments and applications for rheumatologic conditions. Dr. Farrell, a clinical pharmacist at the…
TNF Inhibitors May Not Be Linked to Cancer Risk in Kids
NEW YORK (Reuters Health)—Using tumor necrosis factor (TNF) inhibitors in children is not significantly associated with cancer risk, according to a new study. “TNF inhibitors are remarkably effective for the treatment of many autoimmune conditions, but physicians worry that they cause cancer,” Dr. Timothy Beukelman from the University of Alabama in Birmingham told Reuters Health…
Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead
The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
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