Janssen filed a supplemental new drug application to the FDA for the use of Xarelto, or rivaroxaban, in reducing the risk of acute limb ischemia in patients with peripheral artery disease and of major cardiovascular events in patients with chronic coronary and/or peripheral artery disease. The application was supported by data from a late-stage study, which found that compared with aspirin use alone, the drug reduced cardiovascular events in patients by 24%, death by 22%, stroke by 42% and heart attack by 14%.
AstraZeneca disclosed details on data from its clinical trial to assess the efficacy of its drug candidate Calquence as a treatment for mantle cell lymphoma, which showed its efficacy and resulted in fewer side effects compared with the current standard of care. GSK was also scheduled to publish a study on the effectiveness of its multiple myeloma antibody treatment GSK 2857916, according to presentations made at the American Society of Hematology last week.
The FDA has approved an investigational device exemption for Cerus' late-stage ReCePI study, allowing the firm to progress with the evaluation of its Intercept blood system for red blood cells to be used in patients receiving complex cardiac surgery. Development of the system is supported by the Biomedical Advanced Research and Development Authority.
The CMS' clinical lab fee schedule for 2018 would make cuts to 75% of all tests, creating "new barriers to patient access to care," AACC says. "One unintended consequence of the proposed CLFS is that it may force many laboratories to stop or significantly curtail their testing, particularly rural hospitals, small health clinics, and physician office laboratories," AACC warned the CMS.
The Medicare Payment Advisory Commission says the CMS' Merit-based Incentive Payment System should be replaced by a voluntary program under which clinicians could choose to participate in a value-based reimbursement system scored on population-based measures and claims data. The proposal comes after many health care providers said they are unprepared for the financial and administrative requirements of the Medicare Access and CHIP Reauthorization Act's Quality Payment Program.
A study supported by the National Heart, Lung, and Blood Institute found that the delivery of powerful clot-busting drugs via catheter for the prevention of post-thrombotic syndrome in patients with deep vein thrombosis was associated with minimal benefit, based on data for almost 700 participants with DVT. The study in The New England Journal of Medicine found similar rates of post-thrombotic syndrome with and without the procedure, but rates of dangerous bleeding were higher with the procedure.
The prevalence of multimorbidity among Americans living with HIV and being treated was found to have increased from 8.2% in 2000 to 22.4% in 2009, according to a study of data from 22,969 adult persons living with HIV. The research, published in the journal Clinical Infectious Diseases, evaluated multimorbidity trends among PLWH taking antiretroviral therapy who had age-associated co-existing conditions.
Nearly 90 blood cancer research projects in St. Louis will share a total of over $1.7 million in grants from the Leukemia & Lymphoma Society. Among the 87 recipients are four researchers at Washington University School of Medicine.
Researchers with the University of California at San Diego School of Medicine found that high levels of the ADAR1 enzyme are associated with decreased survival rates among multiple myeloma patients, according to a study in the journal Nature Communications. Regeneration of multiple myeloma cells was reduced in mice without the enzyme.
A study published in Hepatology found no correlation between direct-acting antivirals used to treat hepatitis C and higher risks for hepatocellular carcinoma. The study, which included patients who were treated and untreated and with and without cirrhosis, found that those who developed HCC after treatment had higher baseline risk factors.