(Reuters)—Canadian drug maker Valeant Pharmaceuticals International Inc. said it had priced its recently approved plaque psoriasis treatment at $3,500 per month, ahead of an expected U.S. launch in the second half of 2017. Brodalumab (Siliq) is the lowest priced injectable biologic psoriasis treatment currently on the market, Valeant says. Drugmakers are facing intense criticism from…
Articles by Natasha Yetman
Opioid Use Common Even After Minor Surgery
(Reuters Health)—The risk that surgery patients will become chronic opioid users may be similar after minor procedures or major operations, a U.S. study suggests. Three to six months after surgery, new chronic opioid use was about 5.9% with minor operations and 6.5% with major surgery, the study found. The rate was just 0.4% in people…
U.S. FDA Declines to Approve Eli Lilly & Incyte Arthritis Drug
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
Trump Administration Issues Final Rule on Stricter Obamacare Enrollment
WASHINGTON (Reuters)—The Trump administration on Thursday issued a final rule that will shorten the Obamacare enrollment period and give insurers more of what they say they need in the individual insurance market, likely making it harder for some consumers to purchase insurance, healthcare experts say. It could also raise out-of-pocket medical expenses, the experts say,…
Spinal Manipulation Might Help Ease Acute Low Back Pain
(Reuters Health)—Spinal manipulation may work as well for easing lower back pain as anti-inflammatory medications, a research review concludes. Based on data from 15 previously conducted trials involving a total of 1,711 adults, the study team found that spinal manipulation achieved meaningful reductions in pain and improvements in function after six weeks of treatment. The…
Insufficient Evidence Regarding Osteoporosis Medications in Kidney Patients
NEW YORK (Reuters Health)—There are insufficient data to make evidence-based decisions regarding the benefits and harms of osteoporosis medications in patients with chronic kidney disease (CKD), according to a systematic review and meta-analysis. “We found low to moderate evidence for the effects of some but not all of the medications, and the evidence was limited…
FDA Warns Mylan Over Quality Concerns at India Facility
(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of…
Corbus Pharma Outlines U.S. Approval Path for Scleroderma Drug
(Reuters)—The U.S. Food and Drug Administration needs Corbus Pharmaceuticals to show positive data from only one late-stage study on its experimental treatment for scleroderma to support a marketing application, the company said. Corbus said on Wednesday it expects to start the study on 270 patients in the fourth quarter and that it was in talks…
Trump Nominee to Lead FDA Probed on Ties to Pharmacy Industry
(Reuters)—President Donald Trump’s nominee to lead the U.S. Food and Drug Administration, Dr. Scott Gottlieb, was questioned about his ties to the pharmaceutical industry by Democrats on a key Senate committee on Wednesday ahead of a vote on whether to advance his nomination for a vote by the full Senate. Gottlieb, 44, is a former…
Recommendations for Sjögren’s Syndrome: How to Address Biologics & Musculoskeletal Pain
The clinical practice guidelines for managing Sjögren’s syndrome, developed by the Sjögren’s Syndrome Foundation with the ACR, were designed to improve quality and consistency of care. In total, 19 recommendations were agreed on, which include managing the rheumatic and systemic aspects of the disease. Recommendations include a decision tree for the use of DMARDs for inflammatory musculoskeletal pain, use of self-care measures and exercise to reduce fatigue, and the use of rituximab in selected clinical settings for oral and ocular dryness…
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