(Reuters)—Johnson & Johnson’s blockbuster psoriasis drug ustekinumab (Stelara) led to a significant reduction in disease activity in patients with systemic lupus compared with a placebo in a midstage clinical trial, according to data released on Nov. 4. Ustekinumab is already approved for psoriasis, psoriatic arthritis and Crohn’s disease and had third-quarter sales of $1.12 billion….
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…
New Jersey Sues OxyContin Maker, Links Marketing to Opioid Crisis
(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,…
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