Erythropoiesis News and Research

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Acceleron commences ACE-536 phase 2 study in beta-thalassemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced the initiation of a phase 2 study of its novel, investigational protein therapeutic, ACE-536, to treat patients with beta-thalassemia, a genetic hematologic disorder causing chronic and life-threatening anemia and serious complications affecting the spleen, liver and heart.

7 Mar 2013

FDA alerts patients and health care providers of voluntary recall of Omontys by Affymax

The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill.

25 Feb 2013

Acceleron commences ACE-536 phase 2 study in myelodysplastic syndromes

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced the initiation of a phase 2 study of its investigational protein therapeutic, ACE-536, to treat anemia in patients with myelodysplastic syndromes (MDS).

30 Jan 2013

NOXXON commences NOX-H94 Phase IIa trial to treat anemia of chronic disease

NOXXON Pharma today announced the treatment of the first patients in a Phase IIa clinical trial of its anti-hepcidin Spiegelmer NOX-H94 to treat anemia associated with chronic disease.

5 Dec 2012

Takeda, Affymax announce data from OMONTYS Phase 3 studies on anemia due to CKD

Affymax, Inc. and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) today announced the presentation of post-hoc sub-group analyses of the EMERALD Phase 3 studies that evaluated OMONTYS (peginesatide) Injection, an erythropoiesis-stimulating agent (ESA), for the treatment of anemia due to chronic kidney disease (CKD) in adult dialysis patients.

2 Nov 2012

ASN's top five recommendations to avoid wasteful and harmful medical interventions

Earlier this year, the American Society of Nephrology (ASN), the world's leading kidney organization, joined other groups in a campaign to help health care professionals and patients avoid wasteful and sometimes harmful medical interventions. A new article in the Clinical Journal of the American Society of Nephrology (CJASN) outlines the ASN's top five recommendations for the campaign and the rationale behind them.

14 Sep 2012

GeneTex to introduce new antibody against hypoxia-inducible factor 1alpha

GeneTex, Inc., a leading manufacturer of antibodies, has announced that they will be launching a new antibody against HIF1a (hypoxia-inducible factor 1alpha).

29 Aug 2012

EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

AMAG Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

23 Jun 2012

ASN participates in ABIM Foundation's Choosing Wisely campaign

The American Society of Nephrology (ASN), the world's leading kidney organization, joins the American Board of Internal Medicine (ABIM) Foundation, eight other leading national medical specialty societies, and Consumer Reports in the new Choosing Wisely campaign that helps health care professionals and patients avoid wasteful and sometimes harmful medical interventions.

5 Apr 2012

Infections in older adults may increase risk of hospitalization for dangerous blood clots

Research shows older adults who get infections of any kind - such as urinary, skin, or respiratory tract infections - are nearly three times more likely to be hospitalized for a dangerous blood clot in their deep veins or lungs, University of Michigan Health System research shows.

4 Apr 2012

FDA approves Omontys - new anemia drug for chronic kidney disease patients

The Food and Drug Administration (FDA) on Tuesday approved a new drug called Omontys (peginesatide). This is expected to oust Amgen Inc.’s from its near monopoly in the roughly $6 billion U.S. anemia treatment market.

28 Mar 2012

New federal drug label recommendations for CKD patients

The U.S. Food and Drug Administration (FDA) recently recommended that clinicians be more conservative when they prescribe chronic kidney disease (CKD) patients with drugs that treat red blood cell deficiencies. But the drug label's recommendations fall short, according to two commentaries appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology.

20 Jan 2012

FDA advisory panel OKs anemia drug peginesatide

Once approved by the FDA, the once-monthly injection could capture a share of the $3 billion U.S. market for anemia drugs used for kidney dialysis patients, currently dominated by Amgen Inc's blockbuster Epogen. Affymax, which developed the drug with partner Takeda Pharmaceutical Co Ltd, is also expected to price its product below Epogen.

8 Dec 2011

Research: lncRNA affects apoptosis and plays a role in RBC development

A long non-coding RNA (lncRNA) regulates programmed cell death during one of the final stages of red blood cell differentiation, according to Whitehead Institute researchers. This is the first time a lncRNA has been found to play a role in red blood cell development and the first time a lncRNA has been shown to affect programmed cell death.

8 Dec 2011

FDA's ODAC to review Affymax peginesatide NDA for treatment of CKD-associated anemia

Affymax, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session.

24 Oct 2011

Study identifies gene mutation responsible for higher frequency of Italian CDA II

Many of you might know that Congenital Dyserythropoietic Anemia type II (CDA II) is a rare blood disorder, due to a failure in final part of erythropoiesis. What will surprise you is the fact that some mutations responsible for the disease can be tracked 3.000 years back.

10 Oct 2011

Acceleron commences ACE-536 Phase 1 clinical trial in anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases today announced that it has initiated a Phase 1 clinical study of ACE-536.

14 Sep 2011

FDA assigns PDUFA action date for review of Affymax peginesatide NDA

Affymax, Inc. today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide New Drug Application.

12 Aug 2011

FDA acceptance of peginesatide NDA triggers $10M milestone payment to Affymax

Affymax, Inc. today announced that it has received a $10 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide (formerly known as Hematide™), Affymax's investigational drug for the treatment of anemia in chronic renal failure patients.

10 Aug 2011

Acceleron, Celgene enter development collaboration for ACE-536 protein therapeutic to treat anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, and Celgene Corporation today announced that the companies have entered into a joint development and commercialization agreement for ACE-536 for the treatment of anemia.

3 Aug 2011