The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
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
FDA Update: FX006 Promising for Knee OA; Pioglitazone Linked to Bladder Cancer Risk; & HIV Drug Gets New Labeling
The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…
Certolizumab Pegol Usage Compatible with Breastfeeding
In a small-scale study, researchers found that no, or minimal amounts of, certolizumab pegol transfers from mothers taking the drug to nursing infants…
The OPAL Beyond Study: Tofacitinib Phase 3 Results Positive for Treating PsA
In a recent study, patients with psoriatic arthritis taking tofacitinib had a decrease in disease activity compared with placebo…
GCA Relapse Possible When Discontinuing Tocilizumab
A recent study found that although patients with giant cell arteritis respond positively to long-term tocilizumab treatment, relapse may occur after discontinuing the medication…
Rheumatology Drug Updates: Celecoxib and Cardiovascular Safety Trial Results Reviewed
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor rofecoxib in September 2004, when the question of cardiovascular safety of NSAIDs first came into the limelight.2 Valdecoxib (Bextra) was subsequently withdrawn from the market in April 2005 due to…
Celecoxib & Cardiovascular Death: NSAID Safety Under Review
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen…
FDA Update on Rituximab & Etanercept; Plus New ACP Gout Guideline
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…
Reinitiating TNF Blockers after Tuberculosis Treatment
A retrospective study showed that patients who have rheumatic disease and develop tuberculosis may be able to resume anti-TNF therapy and other biologic agents…
Sarilumab Approval Stalled; Piclidenoson Promising for Psoriasis
Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…
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