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The U.S. Food and Drug Administration (FDA) has given type 2 diabetes drug Farxiga (dapagliflozin) a fast track designation that aims to help chronic kidney disease (CKD) patients. AstraZeneca (Cambridge, UK) announced that the drug was fast tracked for development as a treatment to delay the progression of kidney failure and prevent cardiovascular and renal death in patients with CKD.

The company noted, however, the drug is contraindicated for patients with severe kidney impairment (with an eGFR <30 mL/min/1.73 m2), with end stage kidney disease, or who are on dialysis.

The drug is also not recommended for patients

In the spring of 2020, nephrologist Reshma Kewalramani, MD, FASN, will assume the mantle of president and CEO of Vertex (Boston), a biotechnology company with revenues of $3.04 billion for fiscal year 2018. She will move up from her current position as executive vice president for global medicines development and medical affairs and chief medical officer at the company.

Kewalramani will follow Jeffrey Leiden, MD, PhD, who served in these roles for seven years and who oversaw hearty growth. According to Statnews.com, Vertex’s share price rose 360% and its sales doubled to just over $3 billion annually in

Remote dialysis monitoring services are vying for new customers, as dialysis usage in differing settings continues to grow, spurred by the recent U.S. executive order under the Advancing American Kidney Health initiative, which aims to encourage home-based dialysis,.

One of the most recent announcements about a remote-monitoring opportunity comes from Graftworx in San Francisco. The technology company has begun a service evaluation collaborating in northeast England with the Academic Health Science Network and the National Health Service (NHS) Hospital Foundation Trust. That evaluation could result in studies that use the company’s technology “to assess patients on dialysis and those with

New reports on the markets for vascular grafts, including hemodialysis grafts, provide insights into this growing industry.

Grand View Research, based in San Francisco, reports that the global vascular grafts market was valued at $2.01 billion in 2019 and is expected to see a compound annual growth rate (CAGR) of 6.4% from 2019 to 2026. One caveat posits the estimate may be lower owing to “low reimbursement and high out-of-pocket expenditure in emerging economies.”

Overall the marketplace is divided into hemodialysis access grafts, peripheral vascular grafts, and endovascular stent grafts, the lattermost of which led the overall market in 2018.

Although its drug for use in patients with autosomal dominant polycystic kidney disease (ADPKD) is still pending FDA approval, Reata (Irving, TX) recently won orphan drug designation for the candidate drug, bardoxolone methyl, according to Zacks Equity Research.

In early June, the company started its phase 3 clinical trial, called the FALCON study, for patients with ADPKD, which is caused by mutations in the PKD1 and PKD2 genes, and often leads to end stage kidney disease.

This is the second orphan drug designation for treating patients with rare forms of kidney disease with bardoxolone. It is the third designation for

Several clinical trials presented at the American Diabetes Association meeting in June 2019 show promise in terms of improved renal function in type 2 diabetes patients.

Ertugliflozin, a type 2 diabetes drug manufactured as Steglatro by Merck (White House Station, NJ) and in partnership with Pfizer (New York, NY) appeared to protect renal function among this patient population, according to data pooled from two randomized trials, reported EndocrinologyAdvisor.com. Participants were divided into groups taking ertugliflozin 5 mg, ertugliflozin 15 mg, glimepiride, or placebo. The drug is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

At baseline, mean estimated glomerular filtration rate (eGFR)

Certain lots of a Baxter International dialyzer have been voluntarily recalled. The Deerfield, IL-based company reported one “serious injury” possibly associated with the issue.

The Revaclear Dialyzer 300 and 400 model lots were being recalled due to blood leaks. One product line at the manufacturing facility was traced as the problem area and corrections were implemented, according to a two-page letter from Merle Goddard, senior director of quality at Baxter HealthCare.

For more information, contact Baxter at 888-229-0001. Baxter Healthcare Center for Service is providing a credit for returned dialyzers.

Any adverse reactions or quality problems experienced with the dialyzers

Rockwell Medical, Inc. (Wixom, MI) announced that the United States has approved commercial sales of Dialysate Triferic.

The company is developing multiple formulations of Triferic for treating anemia in adult hemodialysis patients. Dialysate Triferic is the first formulation to be sold. Rockwell expects to file a New Drug Application (NDA) with the FDA for its next formulation, I.V. Triferic, within the second quarter of 2019, the company said in a media release.

Rockwell received a preliminary recommendation from the Centers for Medicare & Medicaid Services (CMS) on April 26, 2019. Receipt of final approval would result in a unique J-code

Kent Thiry has resigned as chairman and chief executive officer of DaVita (Denver, CO), one of the largest kidney care services companies in the world. After 20 years in the role, the colorful CEO was practically synonymous with the company.

MarketWatch reports that he will transition to executive chairman of DaVita. Javier Rodriguez takes over as CEO of the company (after serving as CEO of DaVita Kidney Care).

When Thiry took over the business in 1999, it was called Total Renal Care. Chief Executive Magazine in 2009 wrote rhapsodically about what the CEO had managed to accomplish in

News concerning combination drugs in the kidney cancer space continues apace. Recently, Merck & Co. and Pfizer obtained approval from the US Food and Drug Administration (FDA) for a combination of Merck’s Keytruda (pembrolizumab) and Pfizer’s Inlyta (axitinib) as a frontline treatment for patients with advanced renal cell carcinoma.

OncLive reported that the findings from the phase 3 KEYNOTE-426 trial showed that the frontline combination significantly improved overall response rates (ORRs), as well as progression-free and overall survival compared with Pfizer’s Sutent (sunitinib), a tyrosine kinase inhibitor. The data showed that the combination reduced the risk of death by 47%