(Reuters)—U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.1 The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking…
Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
Year in Review: The ACR Advances Education, Rheumatic Disease Awareness, Strategic Planning in 2017
It seems like yesterday I was asked to write my first presidential column, and here I am penning my last. It’s incredible how fast the time goes and yet how much gets done. That progress is made possible by the dedicated and talented group of ACR volunteers and staff. This year, the College has had…
Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis
In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…
FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse
The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
Supplemental Application for Denosumab Goes to FDA
The FDA accepted for review a supplemental biologics license application for denosumab to treat patients with glucocorticoid-induced osteoporosis…
FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages
(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
Flexion’s Knee Pain Drug Gets FDA Approval
(Reuters)—Flexion Therapeutics Inc. said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration. The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency. The…
Efficacy Studied Following Accelerated Drug Approvals
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
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