Renal Business Today

Affymax

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
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
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
FDA Accepts New Drug Application for Peginesatide

PALO ALTO, Calif.—The U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Affymax and Takeda’s anemia drug peginesatide, which is being developed to treat anemia in dialysis patients. ...More
July 27, 2011
Posted in News, Clinical & Pharma, Government & Regulation
Affymax Names Vice President of Medical Affairs

PALO ALTO, Calif.—Affymax has named nephrologist Andrew T. Blair, MD, as the biopharmaceutical company’s new vice president of Medical Affairs. ...More
April 13, 2011
Posted in News, Business
Affymax Appoints New CEO

PALO ALTO, Calif.—Affymax Inc. has appointed John Orwin, to be the company’s new chief executive officer succeeding Arlene Morris. ...More
January 7, 2011
Posted in News, Business
Affymax, Takeda Confirm Hematide Strategy

PALO ALTO, Calif.—Affymax and Takeda Pharmaceutical announced Nov. 29 that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, ...More
November 29, 2010
Posted in News, Business, Government & Regulation
Affymax Looking to Submit Hematide Approval in 2011

PALO ALTO, Calif.—Affymax Inc. and Takeda Pharmaceutical Company Limited said Aug. 5 they are looking to submit an approval application for their anemia drug Hematide to the U.S. Food and Drug Administration by the first half of 2011. ...More
August 6, 2010
Posted in News, Clinical & Pharma, Government & Regulation
Affymax Completes Phase 3 Hematide Treatment, Follow-up

PALO ALTO, Calif.—Affymax Inc. said it has completed the treatment and follow-up of patients with anemia due to chronic renal failure enrolled in the four-trial, phase 3 clinical program for the investigational drug Hematide ...More
January 25, 2010
Posted in News, Business, Clinical & Pharma
Affymax to continue Phase 3 Hematide program after favorable results

PALO ALTO, Calif.--Affymax, Inc. will continue phase 3 studies of its anemia drug Hematide after the independent Data Monitoring Committee (DMC) found that safety data from two trials support the continuation of the studies. ...More
August 11, 2008
Posted in News, Business, Clinical & Pharma

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