The FDA has issued a new boxed warning for Droxia (hydroxyurea). Also, according to a new study, RA patients receiving rituximab should be monitored for late-onset neutropenia…
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
Epratuzumab Results Disappointing, but Adalimumab Promising
Two Phase 3 trials have shown that epratuzumab did not meet its primary endpoints for treating SLE. Meanwhile, a Phase 3 study has shown adalimumab is effective for treating enthesitis-related arthritis in juveniles…
Biosimilar Drugs for RA Studied in Multiple Trials
Etanercept Biosimilars A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection…
FDA Investigates MRI Safety after Studies Find GBCA Deposits in Brain
The FDA is investigating the safety of MRIs using gadolinium-based contrast agents, which recent studies have shown may leave deposits of those chemicals in patients’ brain tissue after multiple scans…
Brentuximab Vedotin Enters Phase 2 Trials & More
Phase 2 clinical trials have begun to assess the safety of brentuximab vedotin for the treatment of SLE. Also, the FDA is reviewing an application for a once-daily tofacitinib citrate tablet to treat RA…
FDA Issues Stronger NSAIDs Warning
The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction…
Abaloparatide-SC May Reduce Fractures for Osteoporosis & New FDA Safety Website
In a 25 month Phase 3 trial, abaloparatide-SC reduced the risk of new fractures in patients suffering from postmenopausal osteoporosis. Plus, the FDA launches a new drug safety website.
Phase 3 Studies Evaluate Lesinurad for Gout Treatment
For 12 months, two studies examined the use of lesinurad in combination with allopurinol to treat gout, with patients achieving reduced serum uric acid levels and demonstrating no severe toxicity.
Biosimilar Drug Updates Reported from EULAR
At the 2015 meeting of the European League Against Rheumatism in June, multiple studies were presented comparing the use of different biosimilar and biologic drugs in treating rheumatoid arthritis…
Guselkumab Studied to Treat RA & Plaque Psoriasis
In a Phase 2 study, researchers evaluated the effectiveness of guselkumab to alleviate symptoms in patients with active RA suffering from tender and swollen joints.
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