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Search results for: psoriasis

Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles

John Miller  |  September 1, 2016

ZURICH (Reuters)—Novartis has won U.S. approval for a copy of Amgen’s blockbuster arthritis drug Enbrel, but the Swiss drugmaker’s bid to muscle in on the medicine’s $4.7 billion in annual U.S. revenue remains blocked by court battles. Novartis’s Sandoz unit said on Tuesday the U.S. Food and Drug Administration (FDA) approved Erelzi, its biosimilar copy…

Filed under:Biologics/DMARDsDrug UpdatesProfessional Topics Tagged with:Biologics & BiosimilarsEnbrelNovartis

U.S. FDA Approves Biosimilar to Etanercept

Reuters Staff  |  August 30, 2016

(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…

Filed under:Biologics/DMARDsDrug Updates Tagged with:Biosimilarsetanerceptetanercept-szzsFDAFood and Drug Administration

Clazakizumab for Adults with Active PsA

Arthritis & Rheumatology  |  August 30, 2016

This is the first clinical trial of an IL-6–targeted therapy in PsA. Clazakizumab may be an effective treatment option for musculoskeletal aspects of PsA, but because of the lack of a dose response in this study, further studies are required to confirm the appropriate dose. The safety profile is consistent with the pharmacology of IL-6 blockade and prior clinical experience with this antibody in rheumatoid arthritis…

Filed under:ConditionsDrug UpdatesPsoriatic ArthritisResearch Rheum Tagged with:Arthritis & Rheumatologyclazakizumabclinical trialsInterleukinPsoriatic ArthritisResearch

FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab

Michele B. Kaufman, PharmD, BCGP  |  August 17, 2016

FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…

Filed under:AnalgesicsBiologics/DMARDsDrug Updates Tagged with:brodalumabFDAFood and Drug Administrationmorphine sulfateOpioidsPainplaque psoriasis

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E-Health, Telemedicine Pose Challenges, Offer Benefits for Patients with Arthritis

Michelle Burda, MLS, & Terence Starz, MD  |  August 11, 2016

A 52-year-old woman comes to the office complaining of a two-month history of pain and swelling in the small joints of her hands, feet and knees. She says, “Doctor, I’ve been searching the Internet, and I think I have rheumatoid arthritis. I have some questions for you.” The healthcare system in the U.S. is changing…

Filed under:ConditionsResearch RheumTechnology Tagged with:ArthritisInternetonlinepatient carepatient communicationResearchRheumatic DiseaserheumatologistrheumatologyTechnologytelehealthtelemedicine

Humira Found Partially Effective against Hidradenitis Suppurativa

Gene Emery  |  August 4, 2016

NEW YORK (Reuters Health) – The anti-inflammatory drug adalimumab can provide significant relief for about a quarter of people who suffer from a moderate-to-severe case of the chronic skin condition hidradenitis suppurativa, according to two 36-week trials. But the drug – which would cost over $104,000 per year for the weekly injections used in the…

Filed under:Biologics/DMARDsDrug Updates

Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting

Michele B. Kaufman, PharmD, BCGP  |  July 15, 2016

In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…

Filed under:Biologics/DMARDsDrug Updates Tagged with:adalimumabBiosimilarsetanerceptFDAFood and Drug Administration

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  July 14, 2016

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

Filed under:Biologics/DMARDsDrug Updates Tagged with:AmgenBiosimilarsetanerceptFDAFood and Drug AdministrationNovartis

Ethics Forum: Unexpected Ethical Issues in Private Practice, Clinical Research

Donah Zack Crawford, MA, Jill Johnson, MD, Neal K. Moskowitz, MD, PhD, & James Udell, MD  |  July 14, 2016

Ethical issues that arise in the average rheumatology practice and in clinical research are often straightforward. The AMA Code of Medical Ethics and the Office Practice and Procedures Manual offer useful information.1 In research, the Protocol and Investigators Agreement spells out who you can enroll and how the trial must be conducted. But still—even when…

Filed under:EthicsPractice SupportResearch Rheum Tagged with:ClinicalEthicspatient carePractice ManagementQualityResearchRheumatic Diseaserheumatologistrheumatology

How HLA-B27 Research Landmarks, Advances Relate to Ankylosing Spondylitis Pathogenesis

How HLA-B27 Research Landmarks, Advances Relate to Ankylosing Spondylitis Pathogenesis

Joerg Ermann, MD  |  July 13, 2016

The mechanistic link between human leukocyte antigen B27 (HLA-B27) and ankylosing spondylitis (AS) is one of the great enigmas in rheumatology. The introduction of biological therapies that target tumor necrosis factor (TNF) or the interleukin (IL) 23/IL-17A axis has had a major impact on the quality of life for many patients with AS, and one…

Filed under:Axial SpondyloarthritisConditionsOther Rheumatic Conditions Tagged with:Ankylosing SpondylitisHLA-B27

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