Rheum for Everyone, Episode 24 (video)| Webinar: ACR/CHEST ILD Guidelines in Practice

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages

Reuters Staff  |  

(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…

Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD

Reuters Staff  |  

NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…

Pain Treatments Move Closer to U.S. Market

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Two pain treatments, extended-release injectable suspension triamcinolone acetonide (Zilretta) and meloxicam, have seen movement at the U.S. Food and Drug Administration (FDA). In October, the agency approved Zilretta to treat osteoarthritis (OA) knee pain and accepted a new drug application for meloxicam to treat pain. FDA Approves Zilretta On Oct. 6, the FDA approved extended-release,…

Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab

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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…

Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?

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As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…

GlaxoSmithKline’s Shingles Vaccine Gets Approval in Canada

Reuters Staff  |  

(Reuters)—Canadian health regulators have approved GlaxoSmithKline’s shingles vaccine, the company said on Friday.1 Shingrix, the British pharma company’s shingles vaccine for people aged 50 years or older, was unanimously recommended for approval by a U.S. Food and Drug Administration (FDA) advisory panel last week. Older people are most at risk of an outbreak of shingles,…

Flexion’s Knee Pain Drug Gets FDA Approval

Divya Grover  |  

(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…

New Jersey Sues Insys as Opioid Maker Settles with Massachusetts

Nate Raymond  |  

BOSTON (Reuters)—New Jersey on Thursday accused Insys Therapeutics Inc of engaging in a fraudulent scheme to boost sales of a fentanyl-based cancer pain drug, as Massachusetts announced a $500,000 settlement with the drugmaker to resolve similar allegations. The lawsuit by New Jersey Attorney General Christopher Porrino accused Insys of illegally directing its sales force to…