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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program

Toni Clarke  |  

(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…

U.S. Antitrust Officials Poised to Block Anthem, Aetna Deals

Reuters Staff  |  

NEW YORK (Reuters)—U.S. antitrust officials are poised to file lawsuits to block Anthem Inc’s acquisition of Cigna Corp., as well as Aetna Inc.’s takeover of Humana Inc., a person familiar with the matter tells Reuters. Antitrust regulators have been scrutinizing the deals and looking at the potential for higher prices if the insurance market consolidates…

Women on Osteoporosis Drugs Still Need Bone Density Screenings

Lisa Rapaport  |  

(Reuters Health)—Women with osteoporosis who take bisphosphonates to help avoid fractures still need to have their bone density monitored, a Canadian study suggests. Researchers who studied more than 6,600 women taking osteoporosis drugs found that for nearly one in five, bone mineral density at the hip actually decreased after the women started taking the medication….

ACR Advocacy at the State Level in 2016

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A majority of state legislatures have concluded their work for 2016. The ACR’s state advocacy efforts continued to focus on policy benefiting rheumatologists and patients alike. The two dominant issues this year were biosimilar substitution and step therapy. Biosimilar Substitution Biosimilar substitution remains the most prevalent issue throughout the states. The ACR continues to monitor…

Valeant Psoriasis Drug’s Suicide Risk Hard to Assess, Say FDA Staff

Reuters Staff  |  

(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…