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Anemia in Medical Technology

Medgenics' Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients

- Results to be presented at Israel Society of Nephrology Conference - EPODURE safety and efficacy now reach 5 months from single treatment - Data continue to indicate that Biopump may offer alternative to scores of expensive injections MISGAV, Israel and LONDON, March 27 /PR...

Medgenics Announces Positive Data From Phase I/II Clinical Trial of EPODURE Treatment of Anemia in Chronic Kidney Disease

-- EPODURE Biopump demonstrates safety and efficacy for four months with single administration -- Institutional Review Board confirms safety and efficacy of low dose and approves continuation of trial with higher doses -- Biopump may offer alternative to months of expensive i...

Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling Hemolysis

Data Suggest Role of Hemolysis in PNH-Related Fatigue Presentation at the European Hematology Association 13th Congress CHESHIRE, Conn., June 15 /PRNewswire-FirstCall/ -- Soliris(R) (eculizumab) therapy improved the often disabling fatigue experienced by patients with the rare blood...

Observational Data Show Transfusion Patterns in Chemotherapy-Induced Anemia Patients Receiving Erythropoiesis-Stimulating Agents

WASHINGTON, Feb. 1 /PRNewswire/ -- Two new analyses of observational data presented at today's Community Oncology Conference reported a significantly lower proportion of patients receiving transfusions when erythropoiesis- stimulating agents (ESAs) treatment was initiated at hemoglobin (Hb) le...

PNH Patients With Lower Levels of Hemolysis, Mild Anemia and Minimal Transfusion Support Have Significant Disease Burden; Soliris(R) Therapy Provided Clinical Improvements in PNH Patients Regardless of Disease Severity

Data Presented at the American Society of Hematology (ASH) Annual Meeting Publication Number: 840 CHESHIRE, Conn., Dec. 11 /PRNewswire-FirstCall/ -- Soliris(R) (eculizumab) therapy reduced hemolysis, fatigue, thromboses (blood clots) and transfusion requirements in patien...

Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients

Results of SHEPHERD Phase III Open Label Trial Published in Online Edition of the Journal Blood CHESHIRE, Conn., Dec. 4 /PRNewswire-FirstCall/ -- Soliris(R) (eculizumab) therapy reduced hemolysis and improved fatigue, overall quality of life and anemia in a diverse popu...

Oncologists Call For Medicare to Reconsider Anemia Drug Restrictions

WASHINGTON, Nov. 9 /PRNewswire-USNewswire/ -- The Community Oncology Alliance (COA), representing community cancer centers nationwide, formally requested that the Centers for Medicare & Medicaid Services (CMS) reconsider its decision to restrict the access of senior cancer patients to vital an...

ASCO and ASH Release Updated Guideline on the Use of Chemotherapy-Related Anemia Treatments in Cancer Patients

WASHINGTON, Oct. 22 /PRNewswire-USNewswire/ -- Today, the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO) have released an updated joint guideline on the use of erythropoiesis-stimulating agents (ESAs), a class of drugs that stimulate the bone marrow t...

Totality of Available Data Reaffirms PROCRIT(R) (Epoetin alfa) Is Safe and Effective When Used Appropriately as Labeled to Treat Chemotherapy-Induced Anemia

BRIDGEWATER, N.J., March 11 /PRNewswire/ -- The totality of scientific data submitted in recent months to the U.S. Food and Drug Administration (FDA) in preparation for the March 13th Oncologic Drugs Advisory Committee Meeting (ODAC) reaffirms that erythropoiesis-stimulating agents (ESAs) are ...

Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia

OSAKA, Japan and PALO ALTO, Calif., Jan. 25 /PRNewswire-FirstCall/ -- Takeda Pharmaceutical Company Limited (TSE: 4502) and Affymax, Inc. (Nasdaq: AFFY ) today announced that Takeda has dosed the first patient in the United States in a clinical trial of the investigational new drug, Hematide(...

Biopure Seeks Compassionate Use Protocol for Treatment of Acute Anemia

CAMBRIDGE, Mass., Aug. 23 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR ) today announced that the company submitted a draft clinical study protocol to the FDA for compassionate use of the investigational product Hemopure (HBOC-201) in the United States. The proposed open label ...

Affymax Announces Results From Phase 2 Clinical Trial of Hematide for the Treatment of Anemia in Dialysis Patients

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 12, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced that results available from its Phase 2 clinical trial of Hematide(TM) dosed monthly in dialysis patients were presented this week at the National Kidney Foundation (NKF) 2007 Spring Clinical Meeting. The...

Data Analyses Outline Efficacy and Safety of Mircera for the Treatment of Renal Anemia Associated With Chronic Kidney Disease

ORLANDO, Fla. and NUTLEY, N.J., April 12, 2007 /PRNewswire-FirstCall/ -- Data analyses from the largest initial registration clinical trial program ever undertaken in the renal anemia arena provide efficacy and safety information on the investigational anemia therapy MIRCERA(TM) for the treatment ...

Affymax Announces Phase 2 Clinical Trial Results of Once-Per-Month Hematide for the Treatment of Anemia in Patients with Early- and End-Stage Chronic Kidney Disease

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 23, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced results to date from two separate Phase 2 clinical trials of Hematide(TM) in dialysis and non-dialysis chronic kidney disease (CKD) patients. The data showed that in treatment naive, non-dialysis patients...

Prospective Model Outlined Potential Time and Cost Savings of Once-Monthly Anemia Treatment

DALLAS, Texas and NUTLEY, N.J., April 23, 2007 /PRNewswire/ -- An activity-based cost analysis demonstrated that if a renal anemia treatment administered once every four weeks replaced thrice weekly administration of epoetin alfa, hemodialysis centers may save an estimated 802 nursing hours and mo...

Researchers Urge Caution in Using ESAs for Cancer-Related Anemia

Drugs Might Increase Risk of Tumor Growth, Data Suggest DURHAM, N.C., April 30, 2007 /PRNewswire/ -- Echoing recent FDA warnings, a research group from Northern Ireland cautions against over-aggressive use of a group of drugs called "erythropoiesis-stimulating agents" (ESAs) to treat anemia in som...

Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia

PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 25, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced that additional Phase 2 clinical trial results for Hematide(TM) were presented at the European Renal Association-EDTA Congress being held in Barcelona, Spain by Iain C. Macdougall, M.D., a Hematide invest...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

...se. Patients aged two years and older who were treatment naive were eligible to participate in the study if they presented with disease-related anemia and had at least one of the following clinical manifestations of Gaucher disease: thrombocytopenia, moderate splenomegaly or a readily palpable enlarg...

FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)

...tish (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myel...

Inspiration for 'My Sister's Keeper' Speaks Out

...lliam B. Schoolcraft, the Nashes were able to select an embryo that met two criteria: it didn't carry the genetic abnormality that would cause Fanconi anemia (FA), an often-fatal genetic disease, and it was a tissue match for Molly Nash who suffered from FA. The selected embryo would later develop to be Mol...

Two New Clinical Studies Show That Limited Exposure to Blood Transfusion Significantly Increases Morbidity and Mortality After Surgery

...to ensure survival when a patient is bleeding heavily or has severe symptomatic anemia. However, transfusions are also given in the presence of stable anemia or when significant blood loss is expected but does not occur. These two new studies add to the growing evidence that transfusions carry life-threate...

Large, Long-Term Study Shows Avandia Has No Increased Overall Cardiovascular Risk Compared to Other Commonly Used Diabetes Medicines

... AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycaemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed. For more infor...

IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant

...r, or the hemoglobin is less than 8 g/dL. Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow depression, and aplastic anemia have been observed in patients treated with Valcyte tablets (and ganciclovir). Other adverse events reported with frequency of greater than or equal t...

Proteolix Presents Positive Clinical Data for Carfilzomib in Multiple Myeloma at the 2009 ASCO Annual Meeting

...benefit response. Carfilzomib was generally well tolerated and toxicities were manageable. The most common adverse events reported were fatigue, anemia and thrombocytopenia. Of note to this patient population, treatment with carfilzomib was associated with a low incidence of peripheral neuropathy, a ...

Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

...nt population was evaluated as a secondary endpoint. Perifosine in combination with capecitabine was well tolerated with hand/foot syndrome (14%) and anemia (11%) as the highest reported grade 3/4 adverse events. Best response and median time to progression of capecitabine + perifosine vs. capecitabi...

Study Showed Lilly's GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients

...patients on the gemcitabine arm died due to causes possibly attributed to treatment-related toxicities. Most side effects were hematologic, including anemia (low red blood cell count), neutropenia (low white blood cell count) and thrombocytopenia (low blood platelet count). "While there have been tr...

Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

...nt population was evaluated as a secondary endpoint. Perifosine in combination with capecitabine was well tolerated with hand/foot syndrome (14%) and anemia (11%) as the highest reported grade 3/4 adverse events. Best response and median time to progression of capecitabine + perifosine vs. capecitabi...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

...ab abnormalities-including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%), and hepat... Grade 3 leukopenia, neutropenia, lymphopenia, and anemia were reported. For DFSP, severe (NCI Grades 3/4) lab abnormalities included anemia (17%), thrombocytopenia (17%), neutropenia (8%), a...

U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold

...oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Statements in this release that are not strictly historical are forward-looking statements, including any statements implying that any ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac diseas...ith PEGINTRON/REBETOL (weight-based) combination therapy in adult patients, anemia with weight-based dosing was 29%; however, the majority of these cases were...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

...etus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potent...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

...etus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potent...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... the HCV SPRINT-1 study is that treatment-emergent anemia appeared to be associated with higher SVR, with an...0 g/dL) having higher SVR rates than those without anemia (hemoglobin did not decrease to less than 10 g/dL). anemia is a known adverse event with combination therapy ...

DaVita Abstracts Accepted Into National Kidney Foundation's 2009 Spring Symposium

... Benner, Ronald Levine DaVita Inc., El Segundo, CA -- Title: Day-To Day, Week-To-Week, and Day-Of-Week Variation in Tests of anemia and Iron Status in Hemodialysis Patients Authors: David B. Van Wyck(1), Harry Alcorn(1), Resmi Gupta(2) (1)DaVita, Inc., El Segund...

U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-of-Hospital Setting

...oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Statements in this release that are not strictly historical are forward-looking statements, including any statements implying that any ...

XTL Biopharmaceuticals Announces the Acquisition of the Use Patent on Recombinant Erythropoietin (rHuEPO) for the Treatment of Multiple Myeloma

...is used in clinical practice for the treatment of various anemias including anemia of kidney disease and cancer-related anemia. ABOUT MULTIPLE MYELOMA... and other vital organs. It is characterized by pain, recurrent infections, anemia and pathological fractures. In the course of the disease, all patients beco...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac diseas...ith PEGINTRON/REBETOL (weight-based) combination therapy in adult patients, anemia with weight-based dosing was 29%; however, the majority of these cases were...

Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports

... in bone metastases clinical trials, regardless of causality, with Zometa 4 mg (n=1031) were as follows: bone pain (55%), nausea (46%), fatigue (39%), anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), a...

Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer

...ia reported in 7% versus 6% of patients - anemia - 20% (Grade 3/4 2%) versus 17% (Grade 3/4 1%) ... respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%) * In patients with multiple myelo... (36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue (36% vs 28%), pyrexia...

Three Studies Presented at the American Society of Hematology Annual Meeting Showed Response to Treatment with Campath(R) in Patients with High-Risk CLL

...ed in 65 patients due to neutropenia (27 percent), anemia (three percent), thrombocytopenia (eight percent),...city. Grade 3/4 neutropenia, thrombocytopenia, and anemia occurred in 56 percent, 57 percent, and 50 percent...opathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single do...
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