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Biologics/DMARDs

FDA Approves First Biosimilar for the Treatment of Cancer

The U.S. Food and Drug Administration  |  September 14, 2017

Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment…

FDA Update: Biosiomilar to Adalimumab Receives FDA Approval

Michele B. Kaufman, PharmD, BCGP  |  September 6, 2017

The FDA has approved adalimumab-adbm, a biosimilar, to treat multiple chronic inflammatory diseases…

Opinion: Help Bring Drug Prices Down

Maarten Boers, MSc, MD, PhD  |  August 22, 2017

I read with interest the articles in the June issue of The Rheumatologist pertaining to high drug costs. Simon Helfgott rheuminated on it, and Susan Bernstein, a medical journalist, wrote a two-page article titled “Concerns About Cost.” Both articles were thoughtful summaries of a complex issue, putting large question marks over both initial prices and…

Sirukumab Approval Stalls

Michele B. Kaufman, PharmD, BCGP  |  August 15, 2017

Citing safety concerns, the FDA Arthritis Advisory Committee voted against recommending approval of sirukumab for treating adults with RA…

Novel Bone Drug Promising in Postmenopausal Osteoporosis

Reuters Staff  |  August 7, 2017

NEW YORK (Reuters Health)—The investigational drug romosozumab led to gains in hip bone mineral density (BMD) that were not seen with teriparatide in older women with osteoporosis transitioning from bisphosphonate therapy in the STRUCTURE study. Amgen’s romosozumab is a monoclonal antibody that inhibits sclerosin, a negative regulator of bone formation. In addition to stimulating bone…

2 Biosimilars Make Their Way Toward the European Market

Michele B. Kaufman, PharmD, BCGP  |  July 17, 2017

Two biosimilar treatments, Rixathon and Imraldi, are moving closer to market release in Europe for the treatment of rheumatic and other diseases…

RA Treatments Show Mixed Results

Thomas R. Collins  |  July 13, 2017

Highlights from the 2017 EULAR Congress MADRID—The anti-IL6 “nanobody,” vobarilizumab, produced mixed results when used with methotrexate (MTX), compared with MTX and placebo, according to results of a 24-week, double-blind Phase 2b study of patients with rheumatoid arthritis (RA), which were presented in an abstract session at the Annual European Congress of Rheumatology (EULAR). The…

FDA Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option

Michele B. Kaufman, PharmD, BCGP  |  June 21, 2017

The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…

News Updates for Diclofenac Sodium, Denosumab & Sarilumab

Michele B. Kaufman, PharmD, BCGP  |  June 20, 2017

In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…

The Birth and Growth of Biotechnology, and the Impact of Biologic Drugs on Rheumatology

Simon M. Helfgott, MD  |  June 15, 2017

Here’s a trivia question: Where were the big ideas for the field of biotechnology first discussed? Answer: At a since-demolished delicatessen in Waikiki Beach, Hawaii. Go figure. The year was 1972, and Stanley Cohen, MD, professor of medicine at Stanford University in Palo Alto, Calif., and Herbert Boyer, PhD, a former professor and biochemist at the…

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