(Reuters)—New Jersey on Tuesday sued Purdue Pharma LP, accusing the OxyContin maker of contributing to the state’s opioid crisis through deceptive marketing to doctors and patients, including the elderly and the “opioid-naive.” Christopher Porrino, the New Jersey attorney general, faulted what he called a decade-long marketing campaign of “almost inconceivable callousness and irresponsibility, and said…
Trump Declares Opioids a U.S. Public Health Emergency
WASHINGTON (Reuters)—U.S. President Donald Trump declared the opioid crisis a public health emergency on Thursday, stopping short of a national emergency declaration he promised months ago that would have freed up more federal money. Responding to a growing problem wreaking havoc in rural areas, Trump’s declaration will redirect federal resources and loosen regulations to combat…
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…
U.S. to Promote Use of Opioid Alternatives to Treat Addiction
(Reuters)—The U.S. Food and Drug Administration plans to encourage opioid addicts to use less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could agitate those in the addiction field who believe abstinence is the only effective treatment. Speaking before the House Committee on Energy and Commerce on Wednesday, FDA…
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…
Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD
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
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
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?
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…
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