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Search results for: Biologics

Medicare Drug Price Negotiation: What ACR Members Need to Know Ahead of Round Three

From the College  |  August 22, 2025

As the program enters its third round of negotiations, ACR members should be aware of several upcoming changes relevant to rheumatology.

Filed under:Legal Updates Tagged with:Medicare Drug Price Negotiation

Lowest Price, Highest Risk? New Drug Policy’s Potential Effect on Rheumatology

From the College  |  August 11, 2025

On July 31, President Trump sent formal letters to the CEOs of 17 major pharmaceutical companies, laying out several requirements the companies must meet within 60 days or face unspecified consequences. These include Most-Favored-Nation pricing for Medicare, Medicaid and private markets.

Filed under:Legal Updates Tagged with:drug pricingMost Favored Nation

FDA Approves Ustekinumab-stba for All Forms & Dosages as Its Reference Product

Michele B. Kaufman, PharmD, BCGP  |  July 16, 2025

Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.

Filed under:Biologics/DMARDsConditionsDrug UpdatesPsoriatic Arthritis Tagged with:Biologics & BiosimilarsBiosimilarsFDAFDA approvalPsA Resource CenterPsoriasisPsoriatic Arthritisustekinumabustekinumab-stba

ACR-Led Resolutions Supporting Research Funding, Biosimilars Access Advance at Annual AMA House of Delegates Meeting

From the College  |  June 23, 2025

An ACR-led resolution that calls for the protection of NIH funding and the ability to negotiate indirect costs will become AMA policy, along with several other resolutions supported by the ACR.

Filed under:American College of RheumatologyLegislation & Advocacy Tagged with:ACR advocacyAMA House of Delegates (HOD)

FDA Approves Upadacitinib for GCA

Michele B. Kaufman, PharmD, BCGP  |  June 16, 2025

Supported by data in patients with new-onset and relapsing giant cell arteritis (GCA), the FDA approved upadacitinib for the treatment of adults with GCA.

Filed under:Biologics/DMARDsConditionsDrug UpdatesVasculitis Tagged with:FDA approvalGCAgiant cell arteritis (GCA)U.S. Food and Drug Administration (FDA)upadacitinib

Incarcerated Individuals with Rheumatic Conditions

Katherine Terracina, MD, & Prajakta P. Masurkar, PhD  |  June 8, 2025

In addition to the impediments to consistent, high-quality care suffered by all incarcerated individuals, incarcerated patients with rheumatic disease face challenges specific to the treatment, management & monitoring of rheumatic conditions.

Filed under:EthicsGuidance Tagged with:Chronic disease managementethical considerationsEthics Forumhealth disparitieshealthcare policymedication accesspatient advocacyprison healthcaretelemedicine

Trials Find Potential Treatments for SLE, Lupus Nephritis

Michele B. Kaufman, PharmD, BCGP  |  May 31, 2025

In summer 2024, two phase 3 studies were released with promising findings for the treatment of patients with systemic lupus erythematosus (SLE) and those with lupus nephritis. SLE Disease Activity Dapirolizumab pegol is a novel, investigational, Fc-free anti-CD40L agent for people living with moderate to severe SLE.1 The randomized, double-blind, parallel-group PHOENYCS GO trial (N=321)…

Filed under:ConditionsDrug UpdatesSystemic Lupus Erythematosus Tagged with:dapirolizumab pegolLupus nephritis supplementobinutuzumab

Belimumab Promising for Children with Lupus Nephritis

Michele B. Kaufman, PharmD, BCGP  |  May 31, 2025

In late July 2022, the U.S. Food & Drug Administration (FDA) approved belimumab (Benlysta) for the treatment of children with active lupus nephritis aged 5 to 17 years old receiving standard therapy.1 Despite recent advances in treatment options for patients with systemic lupus erythematosus (SLE), those with kidney involvement may develop endstage renal disease and…

Filed under:ConditionsDrug UpdatesPediatric ConditionsSystemic Lupus Erythematosus Tagged with:belimumabFDA approvalLupus nephritis supplementPediatric

How to Recognize Inborn Errors of Immunity

Vanessa Caceres  |  May 13, 2025

Inborn errors of immunity may not always be easy to recognize, but rheumatologists should look out for them. Dr. Bharat Kumar shares his insights.

Filed under:ConditionsOther Rheumatic Conditions Tagged with:ACR on Airimmune deficiencyinborn errors of immunitypatient carepodcast

Advocates for Arthritis 2025: United for the Future of Rheumatology Care

From the College  |  May 6, 2025

In visits to Congress members and staff, more than 120 ACR/ARP members and patients urged action to improve patient access to quality treatment. The meetings included discussions about the importance of research funding, ensuring adequate Medicare reimbursement, protecting Medicaid, and making PBMs more transparent and accountable. It’s not too late to amplify their message.

Filed under:From the CollegeLegislation & AdvocacyPractice Support Tagged with:Advocates for Arthritis

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