On February 9th, the Food and Drug Administration (FDA) Arthritis Advisory Committee voted 21-3 in favor of approving the infliximab biosimilar, CT-P13/Inflectra, for use in all of infliximab's indications.
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A recent report from the United States Bone and Joint Initiative (USBJI) estimates that 126.6 million Americans (one in two adults) are affected by a musculoskeletal (MSK) condition; a number on par with the number of Americans living with a chronic lung or heart conditions.
Comparative efficacy trials may be the best way to make informed treatment choices in a sea of treatment options for rheumatoid arthritis (RA). Recent years have seen impressive head-to-head (H2H) clinical trials for RA, including AMPLE (abatacept vs.
In the current issue of JBMR, Kim and colleagues from Brigham and Women's Hospital in Boston assessed US claims data and studied the impact of three FDA drug safety warnings regarding the use of bisphosphonates.
As the number of biosimilars in development keeps on growing, reaching nearly 700 products to date, demand for data from randomized controlled trials (RCTs) and an understanding of these new biologics is peaking the interest of many.
Increased use of MRI for diagnosis of spondyloarthritis (SpA) in the last two decades has led to earlier diagnoses and gradual incorporation of MRI into the SpA assessment toolset.
The good news: in 2015 the FDA approved a record number of new drugs (n=45).
The bad news: most new drugs entering the market today have an exorbitantly high price tag.
On Tuesday February 9th Celltrion presented its biosimilar developmental data to the FDA as they sought approval for their CT-P13 (called Inflectra), a biosimilar of infliximab (Remicade).
The arthritis advisory committee of the Food and Drug Administration (FDA) is scheduled to meet today, February 9th to review the efficacy and safety of Celltrion's biosimilar form of infliximab (Remicade) that is currently marketed in other countries.
Juvenile idiopathic arthritis (JIA) is commonly managed with methotrexate (MTX), with many pediatric rheumatologists preferring to use parenteral MTX for compliance and absorption reasons.
A population-based study of 1,272,424 live-born infants from Denmark and Sweden examined the prevalence of birth defects among infants born to 683 women with chronic inflammatory disease (inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis)
CT-P13, a biosimilar of infliximab (Remicade), demonstrated comparable and durable efficacy in the treatment of ankylosing spondylitis (AS), a multinational study found.
(Reuters Health) – Every year since 2006 in the U.S., the amount of new medical research in humans funded by the National Institutes of Health (NIH) has gone down, while the number of industry-funded trials has gone up, a new study shows.
In 2010, Smolen and a group of international rheumatologists developed a series of recommendations addressing the concept of treat-to-target (T2T) in the management of rheumatoid arthritis (RA).
Biosimilars are the fastest developing product line within the pharmaceutical industry. There is unanimous worldwide interest in the continued use of biologics for immune mediated disorders.
A systematic review of the literature was done to assess the relationship between immunosuppressive therapy, adult systemic lupus erythematosus (SLE) and the onset of progressive multifocal leukoencephalopathy.
Apremilast, a novel phosphodiesterase 4 (PDE4) inhibiting conversion of cyclic AMP to AMP, was approved for treatment of psoriatic arthritis (PsA) after showing its efficacy in 16 weeks PALACE 1, 2, and 3 trials in 2014.
Six volunteers were admitted to the University Hospital of Rennes in France last week after partaking in the Phase I trial of a new medication meant to treat mood disorders such as anxiety.
Comparative Harmful Risks with Targeted Immunomodulators. Desai et al did a systematic review of the literature, findings of 10 head-to-head RCTs and 51 observational studies.
Cosentyx (secukinumab) was approved by the FDA on 15 January, 2016 for patients with active ankyosing spondylitis (AS) and psoriatic arthritis (PsA).
