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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

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

Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review

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The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…

FDA Update: FDA Delays Baricitinib Review & Removes Bupropion & Varenicline Warnings

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FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…

Rheumatology Drug Updates: Giant Cell Arteritis Relapse Possible if Tocilizumab Discontinued; Plus Updates on Rituximab, Etanercept

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GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…