In a global Phase 3 trial, subcutaneous secukinumab proved safe and effective in patients with psoriatic arthritis. Also, a version of aspartyl-alanyl diketopiperazine, a biologic for knee OA, has entered Phase 3 trials…
Search results for: biosimilars
Novartis Biosimilar Takes Aim at Amgen’s Enbrel
ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
Relapse Rates High in IBD Patients who Stop Treatment
NEW YORK (Reuters Health)—Inflammatory bowel disease (IBD) patients who achieve remission on treatment may want to go off their IBD medications. But half or more of those who do will have a relapse, according to comprehensive analysis of relevant research. “Based on the studies with extended periods of follow up, relapse rates after cessation appear…
Depression & Anxiety Linked to Poor Rheumatoid Arthritis Outcomes
NEW YORK (Reuters Health)—Rheumatoid arthritis patients with depression and anxiety symptoms may have worse outcomes and poorer response to prednisolone, a secondary analysis of the CARDERA trial has found. “The strength of association between depression/anxiety and disease activity outcomes and treatment response warrants routine screening,” the study’s lead author Faith Matcham at King’s College London…
ACR/ARHP Annual Meeting Preview
The meeting with something for everyone! Below is a sneak peek at some of the 2015 ACR/ARHP Annual Meeting’s scientific sessions and content specific to each educational track. Basic Science Track Our knowledge of autoimmunity, bone pathology and other aspects of rheumatic disease is expanding rapidly due to the important research data produced by scientists…
Arthritis May Be Worse in Poor Countries, but Seem Worse in Rich Ones
(Reuters Health)—A study of people with rheumatoid arthritis (RA) finds that those in wealthy nations are more troubled by it, even though people in poor countries have more severe symptoms. The results, tallied from 17 countries, suggest that cultural factors may influence patients’ perception of their illness, and possibly even the results of clinical trials…
Novartis Launches First U.S. Biosimilar Drug at 15% Discount
LONDON/ZURICH (Reuters)—Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first biosimilar copy of a biotechnology drug approved in the U.S., at a discount of 15% to the original. The Swiss drugmaker’s generics unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen (filgrastim), would…
Can We Get Closer to a Cure for RA?
Despite new therapeutics, progress for RA patients has virtually stalled over the past 10 years. In this article, the authors discuss many options to advance to a cure and the evidence for them, including the combination of low-dose methotrexate and anti-TNF; targeting angiogenesis and tissue damage pathways directly; antigen-specific therapy; potential combination of TNF and IL17 blockade; and targeting inhibitory receptors and regulatory T cells.
FDA Warns of Severe Joint Pain Risk with DPP-4 Diabetes Drugs
(Reuters)—A class of diabetes drugs that include Merck & Co Inc.’s Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday. The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006,…
FDA Proposes Adding Suffixes to Distinguish Biosimilar Drug Names
WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
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