The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…
International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…
FDA Staff Raises Safety Concerns Over Arthritis Drug Baricitinib
(Reuters)—An experimental rheumatoid arthritis drug developed by Eli Lilly and Co. and Incyte Corp. poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff says, the latest setback to a treatment regulators declined to approve last year. New data provided by the companies in a resubmission of their marketing…
Denosumab May Work Better Than Risedronate for Steroid-Induced Osteoporosis
NEW YORK (Reuters Health)—The RANKL inhibitor denosumab is superior to the bisphosphonate risedronate in increasing bone-mineral density (BMD) at the lumbar spine in patients just starting or continuing steroid therapy, according to 12-month results of a 24-month randomized controlled study. “Glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis and increases the risk of…
Upadacitinib Proves Superiority to Adalimumab in Phase 3 RA Study
Initial results from an ongoing trial show that upadacitinib outperforms adalimumab in achieving ACR20 in patients with rheumatoid arthritis…
FDA Expands Label for Insulin Degludec; Adalimumab Biosimilar Moves Forward After Legal Battle
The FDA has expanded the label for insulin degludec to include data on improved cardiovascular outcomes and deceased severe hypoglycemia…
Nonopioid Medication May Be as Effective as Opioids for Chronic Pain
A recent study compared the efficacy of opioids with nonopioid pain treatments in patients with chronic back pain and hip or knee osteoarthritis. After 12 months, researchers found that treatment with opioids was not superior to treatment with nonopioid medication, with only minor differences in patients’ functional responses to the medications…
FDA to Review Abuse Deterrent Oxycodone Capsule & More
The FDA will discuss a New Drug Application for Remoxy ER during an upcoming advisory committee meeting and recently approved tildrakizumab-asmn to treat adults with plaque psoriasis…
AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023
(Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…
The ACR Updates Biosimilar Position Statement
In March, the ACR released a white paper designed primarily to help rheumatologists and rheumatology health professionals gain an understanding of biosimilars.1 This research-based education piece examines the scientific, economic and prescribing issues related to the use of biosimilars. Now, the ACR has released an update to its official position statement on the use of…
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