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Articles tagged with "FDA"

U.S. FDA Approves Biosimilar to Etanercept

Reuters Staff  |  

(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…

Rheumatology Drug Updates: Infliximab Biosimilar Cross Reacts to Infliximab Antibodies

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Cross Reactions A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to…

U.S. Panel Backs Approval of Abuse-Resistant Opioid Painkiller

Reuters Staff  |  

WASHINGTON (Reuters)—A U.S. advisory panel on Thursday recommended approval of Egalet Corp’s long-acting opioid painkiller, Arymo ER (morphine sulfate), saying it dulls pain and could deter abuse by addicts seeking a quick high. The panel recommended that the U.S. Food and Drug Administration (FDA) approve the drug and said it deters, but does not eliminate,…

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…