DaVita has cut 38 positions in a clinical research arm of the company based in Minneapolis. The cuts are “part of a company decision to discontinue one of three segments in its clinical research division,” a spokesman said in an e-mail to the Minneapolis Star Tribune.
The company will be discontinuing its work in “early clinical research” in Minneapolis and also in Denver, according to the Star Tribune.
The cuts are a further indication that DaVita will concentrate on its core business, dialysis services. In December 2017, DaVita sold off, for $4.9 billion, its DaVita Medical
Dialysis companies have found themselves settling lawsuits recently. Fresenius Medical Care North America (FMCNA) disclosed breaches of protected electronic health information and settled with a federal agency, while American Renal Associates (ARA), without admitting wrongdoing, settled with shareholders.
In early February 2018, FMCNA, a major dialysis provider, settled with the Department of Health and Human Services Office of Civil Rights (OCR).
The settlement involved patient privacy breaches that occurred in 2012, including computers stolen during a break-in, a hard drive on a desktop taken out of service and removed from a facility without a report to the corporate risk manager,
Among the approximately 500,000 people in the United States affected by lupus nephritis each year, most are women. The disease appears in people with systemic lupus erythematosus (SLE).
Aurinia (Victoria, British Columbia) recently launched an educational campaign about lupus nephritis, called ALL IN, to increase support and awareness of the disease. The company’s first offering is a website for patients and families, www.allinforlupusnephritis.com, which provides a community support page, information about lupus nephritis and its management, and other resources. To date, no therapy specifically for lupus nephritis has been approved by the US Food and Drug Administration (FDA).
Two companies are offering products that use artificial intelligence (AI) to help improve kidney conditions.
AI start-up Medial EarlySign (Kfar Malal, Israel) has shown how the combination of AI and electronic health record (EHR) data can facilitate early detection and treatment of kidney problems and can help slow or even help prevent progression to end stage renal disease. AI refers to the concept of machines being able to carry out tasks in a manner considered to be “smart, while Machine Learning is an application of AI based on the idea that we should give machines access to data and let
The National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK) has published draft guidelines for a new renal cell carcinoma treatment. The guidelines support the use of EUSA Pharma’s (Hemel Hempstead, England) Fotivda (tivozanib) as a first-line treatment option for advanced renal cell carcinoma. NICE provides national evidence-based guidance and quality standards to practitioners in the National Health Service.
In clinical trials, patients treated with Fotivda experienced longer progression-free survival—11.9 versus 9.1 months—in the overall population compared with those taking Bayer’s Nexavar (sorafenib). The drug also reduced side effects: 14% of patients on Fotivda compared with
Flying Brands, based in Jersey, United Kingdom, announced that it has received a CE (Conformité Européene) mark approving its Stone Checker software for use in the European Union and some affiliated nations in Europe. The CE seal confirms that a product meets the essential requirements of relevant European health, safety, and environmental protection legislation.
Flying Brands is an investment company that focuses on opportunities in the technology and logistics sectors, and Stone Checker Software Ltd, is part of Flying Brands.
Stone Checker software provides details about kidney stones to aid in clinical decision-making. The semi-automated kidney stone assessment tool generates
RenalGuard Solutions (Milford, MA) said in 2017 that it expected a premarket approval filing for its fluid-management device in 2018, based on its contrast-induced nephropathy (CIN) study, CIN-RG, which is currently enrolling subjects.
The company’s investigational device, RenalGuard, protects patients from acute kidney injury (AKI), including contrast-induced AKI (CI-AKI). The system was designed to rapidly remove contrast dyes that can be toxic to kidneys.
Investigator-sponsored studies in Europe have demonstrated RenalGuard’s effectiveness at preventing CI-AKI in at-risk patients. RenalGuard measures a patient’s urine output and automatically infuses hydration fluid based on the level of urine output. The system is designed
In mid-December, the U.S. Food and Drug Administration announced it had approved Sanofi-Aventis US’s (Bridgewater Township, NJ) Admelog (insulin lispro injection), a short-acting insulin indicated to improve control of blood glucose levels in adults and pediatric patients 3 years and older with type 1 diabetes and adults with type 2 diabetes. Admelog is the first short-acting insulin approved as a “follow-on” product [submitted through the agency’s 505(b)(2) pathway, a shortened route based on comparative evidence with an approved drug].
“With [the] approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,”
A recent, albeit early, study found that a combination of two Genentech drugs, Tecentriq (atezolizumab) and Avastin (bevacizumab), reduced the risk of disease worsening or death as an initial treatment in some individuals with advanced kidney cancer. Genentech is a division of Roche, and is headquartered in South San Francisco, CA.
Compared with Sutent (sunitinib; Pfizer, New York, NY), the combination treatment provided a statistically significant and clinically meaningful co-primary endpoint result in kidney cancer patients whose disease expressed the biomarker PD-L1 protein. The co-primary endpoint was investigator-assessed, progression-free survival for the first-line treatment of individuals with advanced or metastatic