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Search results for: psoriasis

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

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke  |  July 13, 2016

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

Filed under:Biologics/DMARDsDrug Updates Tagged with:ABP 501adalimumabFDAFood and Drug Administrationplaque psoriasisRheumatoid Arthritis (RA)

FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira

Reuters Staff  |  July 8, 2016

(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…

Filed under:Biologics/DMARDsDrug Updates Tagged with:ABP 501AmgenFDAFood and Drug Administrationplaque psoriasisRheumatoid Arthritis (RA)

Periodontal Infection May Determine Best Treatment for Patients with RA

Lara C. Pullen, PhD  |  July 4, 2016

Past research has indicated that a periodontal pathogen that produces the peptidularginine deiminase (PPAD) enzyme may affect levels of anti-cyclic citrullinated peptide antibody. A new study suggests serum anti-PPAD IgG titers might be a useful biomarker for designing a personalized treatment strategy for RA…

Filed under:ConditionsRheumatoid Arthritis Tagged with:BiologicsDisease-modifying antirheumatic drugs (DMARDs)InfectionPeriodontal diseaseRheumatoid Arthritis (RA)

Immunotherapy Largely Untested in Patients with Autoimmune Disease

Andrew M. Seaman  |  June 6, 2016

(Reuters Health)—The safety and effectiveness of cancer immunotherapy is largely unknown in patients with autoimmune diseases, researchers say—and that might account for up to a quarter of individuals with lung cancer. Patients with autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis or psoriasis, have been mostly excluded from clinical trials testing immunotherapies over fears that…

Filed under:Drug Updates Tagged with:Autoimmune diseaseCancerimmunotherapylung

Samsung Bioepis Receives Final European Approval for Its Remicade Copy

Reuters Staff  |  June 1, 2016

SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…

Filed under:Biologics/DMARDsDrug Updates Tagged with:Biosimilarsinfliximabinfliximab-dyybInternationalRemicade

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