FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…

FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…
Psoriatic arthritis (PsA), a chronic inflammatory arthritis characterized by structural damage to the joints, has been associated with reduced health-related quality of life, disability and reduced life expectancy. The joint changes in PsA are characterized radiographically by a combination of erosive and proliferative bone changes, including erosive joint destruction, fluffy periostitis and pencil-in-cup deformities. Radiographic…
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…
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…
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
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…
Joerg Ermann, MD |
The mechanistic link between human leukocyte antigen B27 (HLA-B27) and ankylosing spondylitis (AS) is one of the great enigmas in rheumatology. The introduction of biological therapies that target tumor necrosis factor (TNF) or the interleukin (IL) 23/IL-17A axis has had a major impact on the quality of life for many patients with AS, and one…
HSS Holds First Rheumatology Gala The Hospital for Special Surgery (HSS) in New York City hosted a Rheumatology Gala in May. The event, held at The Park Avenue Armory in Manhattan, was held to increase awareness of HSS’s leading research and treatment of rheumatic diseases—particularly with “high-net worth people,” according to former ACR President Mary…
George A.W. Bruyn, MD, PhD |
I read with interest the Diagnostic View (TR, April), which, according to the authors, represented a case of rhupus, an overlap syndrome of RA and SLE. I challenge this view. My arguments: In the case of erosive RA, typically erosive changes are seen at MTP joints other than MTP1 (e.g., MTP5). In addition, the erosive…
CHICAGO—In October of last year, a 52-year-old woman came to see Kevin Winthrop, MD, MPH, associate professor in infectious diseases, public health and preventive medicine at the Oregon Health & Sciences University. She had rheumatoid arthritis and was taking methotrexate and prednisone. She had had little change in her RA disease severity and was considering…