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Articles tagged with "adalimumab"

Study Says 1 Biosimilar Switch Is OK; Jury Still Out on Multiple Switches

Thomas R. Collins  |  August 17, 2018

AMSTERDAM—As more biosimilar drugs for rheumatic diseases make their way to market, evidence is growing that switching from the originator drug to a biosimilar tends to be effective, while the questions of switching back and forth, and switching multiple times using several different biosimilars, remain to be answered, an expert on the topic said at…

Adalimumab Appears Safe for Treating Pediatric Patients with Autoimmune Disease

Reuters Staff  |  August 8, 2018

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

Michele B. Kaufman, PharmD, BCGP  |  August 8, 2018

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

Marilynn Larkin  |  May 29, 2018

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

Michele B. Kaufman, PharmD, BCGP  |  May 18, 2018

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

Michele B. Kaufman, PharmD, BCGP  |  April 30, 2018

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

Michele B. Kaufman, PharmD, BCGP  |  April 26, 2018

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

Tamara Mathias  |  April 8, 2018

(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

Michele B. Kaufman, PharmD, BCGP  |  February 20, 2018

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

Ankylosing Spondylitis: A Patient’s Perspective

Linda Childers  |  February 18, 2018

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…

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