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…
U.S. & Europe Evaluate Abaloparatide Injection & Europe Approves Marketing Baricitinib for RA
Injectable abaloparatide is being evaluated in the U.S. and Europe to treat postmenopausal women with osteoporosis…
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…
Sirukumab Promising for RA
In a clinical trial, RA patients on sirukumab experienced decreased disease activity and improved physical function…
U.S. Senator Launches Probe into 5 Top Opioid Drugmakers
(Reuters)—U.S. Democratic Senator Claire McCaskill sought on Tuesday details from the nation’s top opioid drugmakers on their sales and marketing practices, as lawmakers step up efforts to tackle the country’s deadly opioid crisis. The Missouri senator’s investigation comes amid an epidemic of opioid addiction, with 91 Americans dying everyday as a result of overdose, according…
Immune-Related Adverse Events with Use of Checkpoint Inhibitors for Immunotherapy of Cancer
Introduction: Major advances in the past two decades have enhanced our understanding of the complex interactions between the immune system and cancer cells and their environment. Genetic and epigenetic alterations in tumor cells result in the expression of diverse antigens that can elicit an immune response, primarily mediated by T cells. Immune responses are regulated…
Would Legalizing Medical Marijuana Help Curb the Opioid Epidemic?
(Reuters Health)—In states that legalized medical marijuana, U.S. hospitals failed to see a predicted influx of pot smokers, but in an unexpected twist, they treated far fewer opioid users, a new study shows. Hospitalization rates for opioid painkiller dependence and abuse dropped on average 23% in states after marijuana was permitted for medicinal purposes, the…
Ustekinumab Has Longer Efficacy Duration than TNFIs for Plaque Psoriasis
When compared with TNFIs, ustekinumab demonstrated a longer drug survival rate in patients with severe plaque psoriasis…
When Starting Biologics for RA, Disease Severity Predicts Likelihood of Remission
NEW YORK (Reuters Health)—After starting biologic therapy for rheumatoid arthritis (RA), patients with higher disease activity at baseline achieved greater improvements in measures of disease activity than those with lower levels of disease, but they were less likely to achieve remission or even low disease activity, according to a new real world analysis of registry data….
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