Renal Business Today

Epogen

FDA Panel Votes in Favor of Affymax Anemia Drug

A federal panel has voted 15-1 in favor of recommending the FDA approval of Affymax's anemia drug peginesatide, according to a Dec. 7 report from the San Francisco Business Times. ...More
December 7, 2011
Posted in Blog, Clinical & Pharma, Government & Regulation
Amgen, DaVita Ink Epogen Deal Through 2018

THOUSAND OAKS, Calif.—DaVita signed on Nov. 15 a supply agreement with Amgen under which Epogen will account for at least 90 percent of the dialysis provider's anemia drug requirements through 2018, according to a Nov. 18 regulatory filing from Amgen. ...More
November 21, 2011
Posted in News, Business
ESRD Population Grows, EPO Use Decreases

The latest numbers from the U.S. Renal Data System (USRDS) have been released and they show an every-growing patient population and downward trend in the use of erythropoietin-stimulating agents (ESAs) ...More
October 19, 2011
Posted in Blog, Government & Regulation
Hospira to Start Phase 3 EPO Trial This Year

LAKE FOREST, Ill.—Hospira Inc. said it will start phase 3 trials of its biosimilar erythropoietin (EPO) after receiving positive results from a phase 1 clinical trial in kidney disease patients with anemia. ...More
September 7, 2011
Posted in News, Clinical & Pharma
DaVita Named in Whistleblower Lawsuit

ATLANTA—In a whistleblower lawsuit, dialysis provider DaVita has been accused of intentionally throwing away extra medication in order to boost reimbursements from Medicare and Medicaid. ...More
July 27, 2011
Posted in News, Government & Regulation
Should ESA Label Change Affect QIP Program?

On June 24, Amgen announced an FDA-approved label change to its anemia drugs Epogen and Aranesp, but could the change conflict with the Quality Improvement Plan (QIP) that is connected to the bundle? ...More
June 27, 2011
Posted in Blog, Government & Regulation
Amgen Updates Labeling for Epogen, Aranesp

THOUSAND OAKS, Calif.—Amgen has modified the labeling of its erythropoiesis-stimulating agents (ESAs)—Aranesp and Epogen—to include information about the increased risk of cardiovascular reactions and updated prescribing information in patients with chronic kidney disease ...More
June 24, 2011
Posted in News, Clinical & Pharma, Government & Regulation
High EPO Dose May Increase Risk in Diabetic Dialysis Patients

BETHESDA, Md.—Higher doses of erythropoietin-stimulating agents (ESAs) may increase the risk of mortality and cardiovascular outcomes in diabetic dialysis patients, according to a study published online June 22 in Kidney International. ...More
June 22, 2011
Posted in News, Clinical & Pharma, Government & Regulation
AAKP Statement on EPO Payment Decision

TAMPA, Fla.—After two months of review, the Centers for Medicare & Medicaid Services (CMS) said it will not change its payment policy on erythropoiesis stimulating agents (ESAs) used to treat anemia in kidney disease. ...More
June 21, 2011
Posted in News, Business, Government & Regulation, Practice Management
Study Reveals Concerns Over EPO in Heart Attack Patients

CHICAGO—Intravenous administration of epoetin alfa, a product that stimulates red blood cell production, to patients with heart attack who were undergoing percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open ...More
May 13, 2011
Posted in News, Clinical & Pharma