The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…
Rheumatology Drug Updates: Celecoxib and Cardiovascular Safety Trial Results Reviewed
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor rofecoxib in September 2004, when the question of cardiovascular safety of NSAIDs first came into the limelight.2 Valdecoxib (Bextra) was subsequently withdrawn from the market in April 2005 due to…
Trump Considering Dr. Scott Gottlieb to Head U.S. FDA
(Reuters)—Dr. Scott Gottlieb, a partner at one of the world’s largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-Elect Donald Trump to run the agency, according to sources close to the transition team. Gottlieb, 44, a venture partner at New Enterprise Associates and…
Celecoxib & Cardiovascular Death: NSAID Safety Under Review
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen…
FDA Update on Rituximab & Etanercept; Plus New ACP Gout Guideline
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…
Second Biosimilar Equivalent to Adalimumab
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…
Many Patients Discontinue Tofacitinib by Year 1; Fasinumab Promising for Pain
A recent analysis found that about 10% of RA patients taking tofacitinib do not follow recommended guidelines and more than half stop treatment by one year…
Tocilizumab Designated as Breakthrough Therapy for GCA
To speed the development of tocilizumab to treat giant cell arteritis (GCA), the FDA designated it as a breakthrough therapy earlier this month…
Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis
Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…
FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…
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