Erythropoiesis News and Research

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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

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Amgen reported total revenue increased 4 percent during the second quarter of 2011 to $3,959 million versus $3,804 million in the second quarter of 2010. Total product sales increased 8 percent in the second quarter of 2011 to $3,893 million versus $3,613 million in the second quarter of 2010. The increase in total revenue in the second quarter of 2011 included a decline in other revenue due to certain milestone payments earned in the second quarter of 2010.

29 Jul 2011

FDA accepts peginesatide NDA for anemia associated with CKD

Affymax, Inc. and Takeda Global Research & Development Center, Inc., U.S., today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for peginesatide (formerly known as Hematide™) for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

27 Jul 2011

FDA directive on anemia drug in kidney disease patients

The U.S. Food and Drug Administration (FDA) has issued new warnings for anemia drugs for patients with kidney disease after studies suggested such drugs could increase stroke risks. The new warnings are the latest to hit the widely used medications since 2007, when the FDA first said they could cause fatal side effects.

27 Jun 2011

FDA recommends conservative dosing guidelines for ESAs to treat anemia in patients with CKD

The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.

27 Jun 2011

Takeda, Affymax submit peginesatide NDA to FDA for treatment of anemia linked with chronic renal failure

Affymax, Inc. and Takeda Pharmaceutical Company Limited today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for the investigational agent peginesatide for the treatment of anemia associated with chronic renal failure in adult patients on dialysis.

31 May 2011

Takeda, Affymax announce additional peginesatide Phase 3 study results in dialysis patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited, today announced results of additional analyses from two Phase 3 studies of the investigational agent, peginesatide in chronic renal failure patients on dialysis with anemia.

29 Apr 2011

FibroGen, Astellas advance FG-4592 to phase 2b development for treatment of anemia in chronic kidney disease

FibroGen, Inc., today announced that FibroGen and partner Astellas Pharma Inc. advanced FG-4592 (Astellas designation ASP1517), an investigational anemia therapy, to phase 2b development for treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis.

18 Mar 2011

Researchers identify class of drugs that can promote RBC formation in anemic patients

By determining how corticosteroids act to promote red blood cell progenitor formation, Whitehead Institute researchers have identified a class of drugs that may be beneficial in anemias, including those resulting from trauma, sepsis, malaria, kidney dialysis, and chemotherapy.

22 Dec 2010

Study: Natural high hemoglobin levels safe for kidney disease patients on dialysis

Naturally occurring high hemoglobin levels are safe for kidney disease patients on dialysis, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

17 Dec 2010

Ligand Pharmaceuticals reports preclinical study data on erythropoietin receptor agonists

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced data from a preclinical study on the erythropoietin (EPO) receptor agonist LG5640 at the upcoming 52nd American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida at the Orange County Convention Center, December 4 - 7, 2010.

6 Dec 2010

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

Keryx announces positive top-line results from Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals, Inc. today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

30 Nov 2010

FG-2216 drug offers new treatment option for kidney disease-related anemia

A new drug called FG-2216 can stimulate production of the hormone erythropoietin (EPO) in dialysis patients—possibly offering a new approach to treatment of kidney disease-related anemia, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

30 Nov 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

FibroGen to present FG-4592 phase 2a study of patients with stage 3-4 Chronic Kidney Disease and anemia

FibroGen, Inc., today announced that new data from a phase 2a study of patients with stage 3-4 Chronic Kidney Disease and anemia will be presented demonstrating that its first-in-class, investigational oral anemia therapy FG-4592 works differently than erythropoiesis stimulating agents (ESAs) to increase hemoglobin.

19 Nov 2010

Bolder BioTechnology receives $1.2 million in Qualifying Therapeutic Discovery Project Grants

Bolder BioTechnology, Inc. today announced that it has been awarded a total of $1.2 million in Qualifying Therapeutic Discovery Project Grants. Grants were awarded for qualified investments under the Qualifying Therapeutic Discovery Project Tax Credit Program, which authorized up to $1 billion in tax credits or grants to biopharmaceutical companies with 250 or fewer employees.

4 Nov 2010

New guideline for using ESAs drugs in cancer patients

An updated joint guideline by the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO) advises physicians about the appropriate use of erythropoiesis-stimulating agents (ESAs), a class of drugs that stimulate the bone marrow to produce more red blood cells, to treat cancer patients with chemotherapy-induced anemia.

27 Oct 2010