Renal Business Today

Amgen

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
Sensipar Label Gets Safety Update

The U.S. Food and Drug Administration has approved a change to the safety labeling of Amgen’s Sensipar (cinacalcet). ...More
September 13, 2011
Posted in Blog, Clinical & Pharma, Government & Regulation
Another Hard Day for the Economy

This week didn’t start much better than the end of last week. ...More
August 8, 2011
Posted in Blog, Business
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
Amgen and J&J Anemia Drugs Won't Face New Coverage Policy

Amgen Inc. and Johnson & Johnson won’t face new reimbursement limits for their anemia medicines. ...More
June 17, 2011
Posted in News, Clinical & Pharma, Government & Regulation
CMS Proposes Not to Change ESA Payment

The Centers for Medicare & Medicaid Services (CMS) has decided that it will not change payment terms, right now, for anemia drugs used to treat dialysis patients, according to news reports. ...More
March 17, 2011
Posted in Blog, Business, Clinical & Pharma, Government & Regulation
AAKP Response to MEDCAC's ESA Decision

TAMPA, Fla.—The American Association of Kidney Patients (AAKP) submitted on Jan. 31 a letter to the Centers for Medicare & Medicaid Services (CMS) on its concerns regarding the outcome of the recent Medicare Evidence Development & Coverage Advisory Committee ...More
February 9, 2011
Posted in News, Government & Regulation
Teva, Barr Can't Sell Generic Sensipar

THOUSAND OAKS, Calif.—Teva Pharmaceuticals and Barr Laboratories will not be able to sell generic versions of Amgen’s Sensipar after a U.S. District Court in Delaware granted an injunction last week. ...More
January 10, 2011
Posted in News, Business, Government & Regulation