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
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
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
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
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
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
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…
Sanofi to Invest Further in Biologics
PARIS (Reuters)—Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential. In contrast to most drugs that are chemically synthesized, many biologics are produced using living cells. They are seen as a promising answer in…
U.S. Supreme Court Speeds Copycat Biologic Drugs to Market
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…
FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA
Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…
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