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

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…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke  |  

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

Dysbiosis of Gut, But Not Ocular Microbiome, Associated with Sjögren’s Syndrome

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Research has explored the connection between Sjögren’s syndrome and intestinal dysbiosis associated with ocular mucosal disease. A recent study found that oral antibiotics and desiccating stress lead to extreme changes in the gut microbiota in mice. In patients with Sjögren’s syndrome, researchers found that patients with the most severe keratoconjunctivitis sicca and combined systemic and ocular disease had the lowest diversity of stool microbiota…

Prescription-Drug Monitoring Saves Lives, Could Save More

Ronnie Cohen  |  

(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…

U.S. Justice Department Has Concerns about Aetna-Humana Deal

Caroline Humer & Diane Bartz  |  

(Reuters)—The U.S. Department of Justice has significant concerns about Aetna Inc.’s proposed acquisition of health insurer Humana Inc., a source familiar with the situation said on Thursday, and shares of Humana fell more than 11%. Aetna’s purchase of Humana would combine two of the largest providers of Medicare Advantage plans for elderly people, and investors…

FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira

Reuters Staff  |  

(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…