Renal Business Today

Hematide

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
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
The Next Challenger to the EPO Monopoly

Editor's Note: The online version of this interview includes corrections from the print version due to transcription innacuracies.At the 45th ERA-EDTA Congress in Stockholm, Palo-Alto, Calif.-basedAffymax presented preliminary data showing its anemia drug Hematide was well ...More
July 31, 2008
Posted in Articles, Business, Clinical & Pharma
Affymax starts enrollment in Phase 2 Hematide study

PALO ALTO, Calif.—Affymax Inc. has started enrollment in to a Phase 2 clinical trial to study whether or not its drug Hematide can correct anemia in dialysis patients who are not being treated with an erythropoiesis stimulating agent. ...More
July 1, 2008
Posted in News, Business, Clinical & Pharma
Hematide well tolerated in CKD patients

STOCKHOLM—Clinical data showed that the anemia drug Hematide given once a month was well-tolerated and maintain hemoglobin levels between 11 and 12 g/dL for one year in patients with chronic kidney disease on and not on dialysis, according to a presentation at the ...More
May 15, 2008
Posted in News, Business, Clinical & Pharma
Affymax doses first patient with Hematide

PALO ALTO, Calif.—Affymax Inc. and Takeda Pharmaceutical Co. said October 11 that the Affymax has dosed the first patient with its drug Hematide in the phase 3 study of the anemia drug in chronic kidney disease patients. The open-label, randomized controlled program has ...More
November 30, 2007
Posted in Articles, Business, Clinical & Pharma, Practice Management

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