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Michele B. Kaufman, PharmD, BCGP

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer and editor. She is also a pharmacist at New York Presbyterian Hospital–Lower Manhattan campus. She has been a past guest lecturer at Touro College of Pharmacy in New York City for the Medical Writing elective. Dr Kaufman is a member of the New York City Society of Health-Systems Pharmacy, the New York State Council of Health-System Pharmacists, the Academy of Managed Care Pharmacy (AMCP)—Northeast Region Affiliate Chapter, the American Society of Consultant Pharmacists and the Empire State-Metropolitan NY Chapter of the American Medical Writers Association. She received her BS in Pharmacy from the University of Rhode Island (URI) College of Pharmacy and her Doctor of Pharmacy degree from Massachusetts College of Pharmacy and Allied Health Sciences in Boston. She also completed a Drug Information Fellowship at the URI Drug Information Center/Roger Williams Medical Center in Providence, R.I. Dr Kaufman is a registered pharmacist and is a Board-Certified Geriatric Pharmacist.

Articles by Michele B. Kaufman, PharmD, BCGP

15,000 Patient-Years: Safety Data for Upadacitinib Treatment Across Multiple Rheumatic Conditions

Michele B. Kaufman, PharmD, BCGP  |  October 17, 2024

Burmester et al. characterized the long-term safety profile of upadacitinib treatment across multiple rheumatic diseases.

Lupus Update: Findings from the Latest Phase 3 Clinical Trials

Michele B. Kaufman, PharmD, BCGP  |  October 11, 2024

Two new treatment studies among patients with systemic lupus erythematosus and lupus nephritis had promising results.

LEVI-04 Promising for Relieving Knee OA Pain

Michele B. Kaufman, PharmD, BCGP  |  September 16, 2024

In a study, all doses of LEVI-04 demonstrated significant pain relief for patients with knee osteoarthritis compared with placebo.

FDA Accepts New Drug Application for Suzetrigine, a Non-Opioid Analgesic

Michele B. Kaufman, PharmD, BCGP  |  September 16, 2024

The FDA accepted a new drug application for suzetrigine, a non-opioid analgesic, based on the results from clinical trials in patients with neuropathy and those post-surgery.

FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA

Michele B. Kaufman, PharmD, BCGP  |  August 13, 2024

Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.

FDA Approves Sarilumab for pJIA

Michele B. Kaufman, PharmD, BCGP  |  July 29, 2024

The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.

FDA Updates Safety & Efficacy Information for Voclosporin

Michele B. Kaufman, PharmD, BCGP  |  July 10, 2024

The FDA’s latest label change for voclosporin adds data demonstrating its safety and efficacy, as well as a sustained renal response, in patients with lupus nephritis through three years of treatment.

FDA Approves Tocilizumab Biosimilar; Plus New Lupus Drug in Early Trials

Michele B. Kaufman, PharmD, BCGP  |  May 30, 2024

The FDA has approved tocilizumab-aazg (Tyenne), the first tocilizumab biosimilar, for treating rheumatic diseases, as well as the new drug application for CB-101, a chimeric antigen receptor T cell therapy, for treating lupus nephritis and extra-renal lupus.

New Indications Possible for Bimekizumab-bkzx

Michele B. Kaufman, PharmD, BCGP  |  May 28, 2024

The FDA has accepted applications for three new indications for bimekizumab-bkzx, a humanized interleukin (IL) 17A and IL-17F antagonist: psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Biosimilars to Denosumab Approved with an Interchangeable Designation

Michele B. Kaufman, PharmD, BCGP  |  April 18, 2024

The FDA has approved the first interchangeable biosimilars for denosumab.

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