Renal Business Today

Phosphate Binders

High Phosphate Levels Interfere with Kidney Meds

WASHINGTON—High blood phosphate levels can set chronic kidney disease (CKD) patients on a rapid path to kidney failure and also interfere with the effectiveness of certain kidney medication, according to a study appearing online in the Journal of the American Society ...More
August 18, 2011
Posted in News, Clinical & Pharma
Nabi Receives $5M Milestone Payment from Fresenius

ROCKVILLE, Md.—Nabi Biopharmaceuticals has received a $5 million payment from Fresenius USA Manufacturing Inc. that was triggered by the first commercial sale of Phoslyra, a milestone under the agreement governing the company's 2006 sale of PhosLo and related assets to ...More
August 16, 2011
Posted in News, Business
GAO: CMS Must Ensure Adequate Payment for Oral Drugs

WASHINGTON—Oral-only ESRD drugs are set to be included in the dialysis bundle in 2014, and the Centers for Medicaid & Medicare Services (CMS) needs to make sure the payments are adequate and that there is reliable data available for monitoring mineral and bone disorder, ...More
March 24, 2011 By Keith Chartier
Posted in Articles, Business, Government & Regulation
Keryx Phosphate Binder Meets Phase 3 Goals

NEW YORK—Keryx Biopharmaceuticals said its iron-based phosphate binder Zerenex met itspPhase 3 primary endpoints. ...More
December 2, 2010
Posted in News, Clinical & Pharma
Discrepancies in Phosphorus Binder Initiation

EXTON, Pa.— There is a significant discrepancy between the phosphorus level at which nephrologists report initiating phosphate binders in non-dialysis kidney disease patients compared to what actually happens based on audited chart figures, according to a new report from ...More
November 29, 2010
Posted in News, Clinical & Pharma
FDA Warns Fresenius Over Dialysis Products

WASHINGTON—In a Sept. 15 letter, the U.S. Food and Drug Administration (FDA) warned Fresenius Medical Care that it had not properly investigated or fixed problems in two dialysis products and also expressed concern over the company’s phosphate drug Phoslo. ...More
October 6, 2010
Posted in News, Government & Regulation
Keryx Starts Phase 3 Study on New Phosphate Binder

NEW YORK—Keryx Biopharmaceuticals Inc. announced Sept. 29 that it has started the long-term Phase 3 study of Zerenex (ferric citrate), the company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with ...More
September 29, 2010
Posted in News, Clinical & Pharma, Government & Regulation
Genzyme 'Encouraged' by Oral-Drug Delay in Bundle

CAMBRIDGE, Mass.—In a July 27 news release, Genzyme Corp. said it was “encouraged” by the Centers for Medicare & Medicaid Services’ (CMS) decision not to immediately include oral medications without IV equivalents in the newly released dialysis bundled payment system. ...More
July 27, 2010
Posted in News, Business
Genzyme Sues Watson Over Generic Renvela Application

MORRISTOWN, N.J.—Watson Pharmaceuticals Inc. said July 12 that it has submitted an application to the U.S. Food and Drug Administration to approve a generic form of Genzyme’s phosphate binder Renvela. ...More
July 13, 2010
Posted in News, Government & Regulation
Generic Renvela Maker Files for FDA Approval

Generic drug makers have been going after phosphate binders for short while now; however, it could reach a fever pitch after Genzyme sued Impax Laboratories on July 1 for trying to create a generic form of Renvela. ...More
July 7, 2010
Posted in Blog, Clinical & Pharma, Government & Regulation