Renal Business Today

Erythropoietin-Stimulating Agents (ESAs)

Hospira Starts Phase 3 of Biosimilar EPO Study

LAKE FOREST, Ill.—Hospira said Jan. 10 that it has started enrollment of the first patient in a Phase 3 U.S. clinical program for its biosimilar erythropoietin (EPO). ...More
January 10, 2012
Posted in News, Clinical & Pharma
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
CMS Raises Dialysis Reimbursement for 2012, Revises QIP

WASHINGTON—The Centers for Medicare & Medicaid Services (CMS) released a final rule Nov. 1 that increases dialysis reimbursement in 2012 and alters the quality incentive program (QIP) by removing the lower hemoglobin target for anemia management in 2013 and expands the ...More
November 2, 2011
Posted in News, Business, Government & Regulation, Practice Management
FDA to Review Peginesatide in December

PALO ALTO, Calif. –The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for Affymax’s peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult ...More
October 24, 2011
Posted in News, 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
Affymax Receives $10 Million Milestone Payment

PALO ALTO, Calif.—Affymax Inc. announced Aug. 10 that it has received a $10 million development milestone payment from Takeda Pharmaceutical Company due to the FDA’s acceptance and filing of a New Drug Application for the anemia drug peginesatide. ...More
August 10, 2011
Posted in News, Business, Clinical & Pharma
Patient Advocate Statement on QIP sub-10 HgB Metric

As an accomplished athlete who has successfully lived on kidney dialysis for almost three decades, and one of the leading advocates for the renal community, I find myself in a position where I need to issue a statement publicly about a decision currently being considered ...More
August 9, 2011
Posted in Articles, Clinical & Pharma, Government & Regulation
Bundle Tightens ESA Use Among Nephrologists

EXTON, Pa.—The dialysis bundle has caused nephrologists to increase the use of iron, increase the use of subcutaneous ESA administration, and lower erythropoeitin-stimulating agent (ESA) dosing by tightening hemoglobin target levels, according to new survey results from ...More
July 11, 2011
Posted in News, Clinical & Pharma, 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