Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…
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…
Music May Help Reduce Pain
(Reuters Health)—As a complement to traditional pain relief tools, such as medication, listening to music may lessen acute or chronic pain related to cancer and other conditions, according to a new review. “We have seen and observed this effect in multiple clinical settings, such as medical hospitals and hospice-care facilities,” says author Dr. Jin Hyung…
U.S. Could File Charges in Generic Drug Probe by Year-End
(Reuters)—U.S. prosecutors could file the first charges in their criminal investigation of generic drugmakers over suspected price collusion by the end of the year, Bloomberg reports. The antitrust investigation by the U.S. Department of Justice (DOJ) spans more than a dozen companies and about two dozen drugs, Bloomberg reports, citing people familiar with the matter….
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…
Proton Pump Inhibitor Use May Be Linked to Bone Mineral Density
The use of proton pump inhibitors may lead to changes in bone mineral density and an increased risk of developing osteoporosis…
Clinical Trial of Ixekizumab for Psoriatic Arthritis Shows Positive Results
A study found that ixekizumab decreases disease activity and increases physical function in biologic-naive patients with active psoriatic arthritis…
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…
Roche Gets Boost from FDA in Bid to Expand Uses for Actemra
ZURICH (Reuters)—The U.S. Food and Drug Administration has granted breakthrough status to Roche’s rheumatoid arthritis medication Actemra (tocilizumab) for giant cell arteritis, the Swiss drugmaker said, a step which could help it broaden applications for the medicine. Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition caused by inflammation of large and medium-sized arteries,…
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