Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the early morning talk shows. In contrast to the television series I binge on later in…
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…
In March, an FDA advisory committee voted that the risks of Opana ER to public health outweigh its benefits as a chronic pain treatment…
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…
(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…
Injectable abaloparatide is being evaluated in the U.S. and Europe to treat postmenopausal women with osteoporosis…
(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…
In a clinical trial, RA patients on sirukumab experienced decreased disease activity and improved physical function…
(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…
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…