(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
Search results for: biosimilars
Samsung Bioepis Humira Biosimilar Wins FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…
New Wins, Ongoing Challenges for ACR Insurance Subcommittee
Corrections to reimbursement system errors with Aetna and a Medicare contractor demonstrate the latest wins for all providers by the ACR’s Insurance Subcommittee. But the committee remains hard at work advocating for rheumatologists on several fronts.
ACR Hill Visits Yield Key Bill Support; Plus Medicare, Biosimilar Wins
Greetings from Washington, D.C., where ACR leaders just held more than 100 meetings on Capitol Hill supporting reforms to step therapy and prior authorization, increased reimbursement for dual-energy X-ray absorptiometry (DXA), solutions to the rheumatology workforce shortage, and rheumatology-specific research at the Pentagon. We’re already hearing great news about our successes: Hours after our visit,…
Rheumatology Drugs at a Glance, Part 2: Psoriasis
Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug option; others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and other medications used to…
IBD Patients Who Switch from Infliximab to Biosimilar See Mixed Results
NEW YORK (Reuters Health)—Patients with inflammatory bowel disease (IBD) can safely switch from infliximab to the biosimilar CT-P13, though they may face a higher risk of clinical relapse, researchers from Spain report. Recent studies have demonstrated the effectiveness and safety of infliximab biosimilars in patients with IBD, but there are limited data about the effectiveness…
Rheumatology Drugs at a Glance, Part 1: Psoriatic Arthritis
Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, Rheumatology Drugs at a Glance, provides streamlined information on the administration of biologic, biosimilar and other medications used to…
U.S. FDA Chief Gottlieb Resigns
WASHINGTON (Reuters)—U.S. Food and Drug Administration (FDA) Chief Scott Gottlieb said he plans to step down in a month, calling into question how the agency will handle critical issues, such as e-cigarette use among teens and efforts to increase competition in prescription drugs. The U.S. Department of Health and Human Services (HHS), which oversees the…
Why & How Our Biologic Drug Discussion with Patients Should Evolve
As we turn the corner on the second decade of biologic use for rheumatic disorders, a reappraisal of approach in our communication with patients is due. In practice, the impact these agents have on patients’ lives justifies the friction rheumatologists face when connecting patients to them. You can understand why older rheumatologists who apprenticed on…
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
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