Subcutaneous belimumab has been approved in the EU to help treat patients with active autoantibody-positive SLE…
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
Bisphosphonate Drug Holiday & Hip Fracture Risk
New research found women on bisphosphonate therapy who take a drug holiday experience a higher rate of hip fracture…
Golimumab Receives 2 More FDA Approvals
The FDA has expanded the indications for golimumab, an anti-TNF-alpha monoclonal antibody, to include the treatment of active psoriatic arthritis and ankylosing spondylitis…
Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis
In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…
FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse
The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
Supplemental Application for Denosumab Goes to FDA
The FDA accepted for review a supplemental biologics license application for denosumab to treat patients with glucocorticoid-induced osteoporosis…
Pain Treatments Move Closer to U.S. Market
Two pain treatments, extended-release injectable suspension triamcinolone acetonide (Zilretta) and meloxicam, have seen movement at the U.S. Food and Drug Administration (FDA). In October, the agency approved Zilretta to treat osteoarthritis (OA) knee pain and accepted a new drug application for meloxicam to treat pain. FDA Approves Zilretta On Oct. 6, the FDA approved extended-release,…
Secukinumab Meets 5-Year Benchmark for Psoriasis
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
Efficacy Studied Following Accelerated Drug Approvals
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
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