NEW YORK (Reuters Health)—Adalimumab appears to be safe for treating pediatric patients with polyarticular juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), psoriasis and Crohn’s disease (CD), according to data from company-sponsored clinical trials. Adalimumab is an anti-tumor necrosis factor monoclonal antibody with demonstrated efficacy in these conditions, but pediatric safety data remains limited. Dr. Gerd…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
Guselkumab May Best Adalimumab for Psoriasis on the Scalp, Palms & Soles
NEW YORK (Reuters Health)—The interleukin 23 inhibitor guselkumab is associated with more improvement in psoriasis on the scalp, palms and/or soles compared with adalimumab, a new analysis suggests. Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center in Portland conducted a secondary analysis of data from the international VOYAGE 1 and VOYAGE 2 studies, double-blind,…
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…
Upadacitinib Proves Superiority to Adalimumab in Phase 3 RA Study
Initial results from an ongoing trial show that upadacitinib outperforms adalimumab in achieving ACR20 in patients with rheumatoid arthritis…
AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023
(Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…
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…
Ankylosing Spondylitis: A Patient’s Perspective
When Marc McClintock first began experiencing back pain, he chalked it up to the rigors of his racing career. For more than 36 years, Mr. McClintock has built and raced stock cars, high-powered race vehicles that compete on short oval or circular dirt or paved tracks. “I live in a commercial building, with my residence on…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
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