(Reuters Health)—Many patients haven’t heard of biosimilars, generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests.1 To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease…
Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles
ZURICH (Reuters)—Novartis has won U.S. approval for a copy of Amgen’s blockbuster arthritis drug Enbrel, but the Swiss drugmaker’s bid to muscle in on the medicine’s $4.7 billion in annual U.S. revenue remains blocked by court battles. Novartis’s Sandoz unit said on Tuesday the U.S. Food and Drug Administration (FDA) approved Erelzi, its biosimilar copy…
U.S. FDA Approves Biosimilar to Etanercept
(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…
Adalimumab Lowers Risk of Uveitic Flare
NEW YORK (Reuters Health)—Adalimumab reduces the risk of uveitic flare after corticosteroid withdrawal in patients with inactive, noninfectious uveitis, according to results from VISUAL II. “Tumor-necrosis factor (TNF) inhibition, which has been demonstrated to have strong efficacy in rheumatologic disorders, can also have significant role in the management of noninfectious uveitis, even amidst the challenges…
Clazakizumab for Adults with Active PsA
This is the first clinical trial of an IL-6–targeted therapy in PsA. Clazakizumab may be an effective treatment option for musculoskeletal aspects of PsA, but because of the lack of a dose response in this study, further studies are required to confirm the appropriate dose. The safety profile is consistent with the pharmacology of IL-6 blockade and prior clinical experience with this antibody in rheumatoid arthritis…
Placebo Outperforms Glucosamine/Chondroitin Sulfate for Knee OA
(Reuters Health)—Glucosamine sulfate and chondroitin sulfate are not more beneficial than placebo treatments for patients with knee osteoarthritis, a recent trial suggests. In a double-blind study, researchers investigated the efficacy of a medicine that delivered both glucosamine and chondroitin sulfate. The 164 participants all had osteoarthritis and moderate to severe knee pain. Half the participants…
FDA Approves Updated Labeling on Risk of Osteonecrosis of the Jaw for Denosumab
Denosumab’s labeling now says a patient’s risk of developing osteonecrosis of the jaw may increase with prolonged exposure…
Can Anything Contain Drug Costs in the U.S.?
(Reuters Health)—The U.S., which spends more on drugs than any other country, might contain costs by limiting market exclusivity for brand name medicines and changing coverage requirements for government health plans, some doctors argue. Although brand-name drugs account for only 10% of all dispensed prescriptions in the U.S., they make up 72% of drug spending,…
A Morphine Alternative with Less Overdose Risk?
(Reuters Health)—Scientists are testing an experimental drug that’s designed to have the painkilling power of morphine without some of the side effects that can lead to overdose deaths. Initial results in mice with the compound known for now as PZM21 suggest it might be less addictive than morphine and other opiate painkillers and avoid respiratory…
FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab
FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…
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