The FDA has approved a single-press, self-injection device for a 100-mg dose of guselkumab for adults with moderate to severe plaque psoriasis…... [Read More]
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 Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
The FDA has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related and other death in RA patients…... [Read More]
Safety Risk with Higher Dose Tofacitnib
According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…... [Read More]
Upadacitinib at the FDA
Upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor, which recently completed phase 3 clinical trials for treating patients with moderate to severe rheumatoid arthritis (RA). In late 2018, AbbVie Inc. submitted a New Drug Application to the U.S. Food and Drug Administration, as well as a marketing authorization application to the European Medicines Agency,… [Read More]
Tanezumab for OA Pain
In a recent study, tanezumab proved more effective than placebo in treating patients with moderate to severe pain caused by hip or knee osteoarthritis…... [Read More]
Biosimilar ABP 798 Promising for RA
A clinical trial in RA patients has established the pharmacokinetic similarity of ABP 798 and rituximab…... [Read More]
Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone
Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…... [Read More]
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.... [Read More]
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…... [Read More]
Results of SPIRIT: A Head-to-Head Trial of Ixekizumab vs. Adalimumab in Active PsA
In a recent study, ixekizumab proved safe and effective in treating adults with psoriatic arthritis (PsA) and plaque psoriasis compared with adalimumab…... [Read More]
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