17 Nov 08 Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.
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Tags: Anemia, Chronic Kidney Disease, Disease Patients, Drug Application, Fda, Ferumoxytol, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Iron Anemia, Iron Deficiency, Iron Deficiency Anemia, Nasdaq, Nda, Pharmaceuticals Inc, Prescription Drug, Response Letter, Target Action
17 Nov 08 Enrollment In EMERALD 1 Complete, 3rd Of 4 Phase 3 Clinical Trials Of Hematide™ To Treat Anemia In Chronic Renal Failure Patients
Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has been completed in EMERALD 1, one of its Phase 3 clinical trials of its lead investigational therapy, Hematide™, which is being evaluated for the treatment of anemia in chronic renal failure patients. EMERALD 1 includes over 800 dialysis patients from over 90 sites in the United States.
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Tags: Affy, Anemia, Chronic Renal Failure, Clinical Trials, Dialysis Patients, Emerald, Failure Patients, Hematide, Lead, Nasdaq, Phase 3, Treatment Failure, Treatment Of Anemia, United States
17 Nov 08 Enrollment In EMERALD 1 Complete, 3rd Of 4 Phase 3 Clinical Trials Of Hematide™ To Treat Anemia In Chronic Renal Failure Patients
Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has been completed in EMERALD 1, one of its Phase 3 clinical trials of its lead investigational therapy, Hematide™, which is being evaluated for the treatment of anemia in chronic renal failure patients. EMERALD 1 includes over 800 dialysis patients from over 90 sites in the United States.
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Tags: Affy, Anemia, Chronic Renal Failure, Clinical Trials, Dialysis Patients, Emerald, Failure Patients, Hematide, Nasdaq, Phase 3, Treatment Failure, Treatment Of Anemia, United States
08 Nov 08 Data From Investigational Use Of PROCRIT® (Epoetin Alfa) Presented At American Society Of Nephrology Annual Meeting
Data from an investigational, open-label, randomized study assessing extended dosing regimens of PROCRIT® (Epoetin alfa) in treating anemia in subjects with Stages 3 - 4 chronic kidney disease (CKD) were presented at the American Society of Nephrology 41st Annual Meeting.
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Tags: American Society Of Nephrology, Anemia, Annual Meeting, Chronic Kidney Disease, Ckd, Epoetin Alfa, Procrit, Regimens
08 Nov 08 Data From Investigational Use Of PROCRIT(R) (Epoetin Alfa) Presented At American Society Of Nephrology Annual Meeting
Data from an investigational, open-label, randomized study assessing extended dosing regimens of PROCRIT(R) (Epoetin alfa) in treating anemia in subjects with Stages 3 - 4 chronic kidney disease (CKD) were presented at the American Society of Nephrology 41st Annual Meeting.
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Tags: American Society Of Nephrology, Anemia, Annual Meeting, Chronic Kidney Disease, Ckd, Epoetin Alfa, Procrit, Regimens
05 Nov 08 Medgenics Announces Encouraging Preliminary Data For Phase I/II Clinical Trial Of EPODURE In Renal Anemia
Medgenics (AIM: MEDG), is pleased to announce encouraging preliminary data for its Phase I/II clinical trial. The landmark Phase I/II clinical trial of Medgenics’ EPODURE Biopump, for providing sustained treatment of anemia in subjects with chronic kidney disease, is underway.
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Tags: Aim, Anemia, Chronic Kidney Disease, Clinical Trial, Landmark, Treatment Of Anemia
05 Nov 08 Renal Anemia - Medgenics Announces Encouraging Preliminary Data For Phase I/II Clinical Trial Of EPODURE
Medgenics (AIM:MEDG), is pleased to announce encouraging preliminary data for its Phase I/II clinical trial. The landmark Phase I/II clinical trial of Medgenics’ EPODURE Biopump, for providing sustained treatment of anemia in subjects with chronic kidney disease, is underway.
(more…)
Tags: Aim, Anemia, Chronic Kidney Disease, Clinical Trial, Landmark, Medgenics, Treatment Of Anemia
05 Nov 08 Affymax Completes Enrollment In PEARL 2, 2nd Of 4 Phase 3 Clinical Trials Of Hematide To Treat Anemia In Chronic Renal Failure Patients
Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has been completed in the second of four Phase 3 clinical trials of its lead investigational therapy, Hematide™, which is being evaluated for the treatment of anemia in chronic renal failure patients. PEARL 2 (Phase 3 Evaluation of Hematide for Anemia Correction in Chronic Renal Failure) is fully enrolled with over 490 non-dialysis patients from over 60 sites in the United States and Europe.
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Tags: Affy, Anemia, Chronic Renal Failure, Clinical Trials, Dialysis Patients, Europe, Failure Patients, Hematide, Lead, Nasdaq, Phase 3, Treatment Failure, Treatment Of Anemia, United States
27 Sep 08 FDA probing deaths in J&J drug study
WASHINGTON (Reuters) - U.S. health officials said on Friday they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a study of stroke patients.
Tags: Amp, Anemia, Anemia Drug, Deaths, Fda, Health Officials, Reuters, Stroke Patients
26 Sep 08 FDA probing deaths in J&J drug study
WASHINGTON (Reuters) - U.S. health officials said on Friday they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a study of stroke patients.
Tags: Amp, Anemia, Anemia Drug, Deaths, Fda, Health Officials, Reuters, Stroke Patients
17 Sep 08 Investors await bone drug data from Amgen (Reuters)
Reuters - Results due next week from a trial of
Amgen Inc's experimental osteoporosis drug denosumab will
represent a pivotal moment for the world's biggest
biotechnology company as it struggles with declining sales of
its flagship anemia drugs.
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Tags: Amgen, Amgen Inc, Anemia, Biotechnology Company, Denosumab, Drugs, Investors, Osteoporosis, Osteoporosis Drug, Pivotal Moment, Reuters
17 Sep 08 Intravenous Iron Improves Treatment Response In Cancer Related Anemia
For patients with chemotherapy-induced anemia, adding intravenous iron to treatment with the drug darbepoetin alfa results in a faster and more potent improvement in response with lower doses of the drug, according to data presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm. Anemia is a common problem in cancer patients, caused by a combination of factors including the malignancy itself, plus the effects of chemotherapy.
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Tags: Anemia, Anemia Treatment, Cancer Patients, Chemotherapy, Congress, Darbepoetin Alfa, Effects Of Chemotherapy, Esmo, Intravenous Iron, Malignancy, Medical Oncology, Oncology, Stockholm, Treatment Response
16 Sep 08 Investors await bone drug data from Amgen (Reuters)
Reuters - Results due next week from a trial of
Amgen Inc's experimental osteoporosis drug denosumab will
represent a pivotal moment for the world's biggest
biotechnology company as it struggles with declining sales of
its flagship anemia drugs.
(more…)
Tags: Amgen, Amgen Inc, Anemia, Biotechnology Company, Denosumab, Drugs, Investors, Osteoporosis, Osteoporosis Drug, Pivotal Moment, Reuters
