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
09 Nov 08 For African Americans With Hypertensive Nephrosclerosis, End Stage Renal Disease Risks Exceed Risk Of Death From Heart Disease
For most patients with chronic kidney disease (CKD), the risk of experiencing a cardiovascular related death is greater than the risk of progressing to end-stage renal disease (ESRD).
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Tags: African Americans, Chronic Disease, Chronic Kidney Disease, Death From Heart Disease, Exceed, Heart Disease, Renal Disease, Risk
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 New Equation Provides More Accurate Estimates Of Kidney Function
A newly developed equation produces more accurate estimates of the glomerular filtration rate (GFR) a key indicator of kidney function in patients with chronic kidney disease (CKD), according to research being presented at the American Society of Nephrology’s 41st Annual Meeting and Scientific Exposition in Philadelphia, Pennsylvania. “Equations to estimate GFR are routinely used to assess kidney function and to detect, evaluate, and manage CKD,” comments Andrew S.
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Tags: Accurate Estimates, American Society Of Nephrology, Annual Meeting, Chronic Kidney Disease, Exposition, Glomerular Filtration Rate, Kidney Function, Philadelphia Pennsylvania
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.
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Tags: Aim, Anemia, Chronic Kidney Disease, Clinical Trial, Landmark, Medgenics, Treatment Of Anemia
16 Oct 08 FDA Grants Orphan Drug Status To Reata’s RTA 402 For Treatment Of Pancreatic Cancer
Reata Pharmaceuticals, Inc. announces that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease. “Pancreatic cancer is a devastating disease with few effective therapies,” said Warren Huff, CEO of Reata.
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Tags: Ceo, Chronic Kidney Disease, Fda, Fda Grants, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Huff, Kidney Cancer, Orphan Drug Designation, Orphan Drug Status, Pharmaceuticals Inc, Phase 1, Phase 2, Rta, Treatment Of Pancreatic Cancer
22 Sep 08 3rd Annual Cardiometabolic Health Congress, Boston
The 2008 Cardiometabolic Health Congress (CMHC) will hold its third annual meeting October 15-18, 2008, at the Sheraton Boston Hotel. Over 1,000 clinicians will attend educational sessions focusing on cardiometabolic risk, including the prevention and management of diabetes, obesity, hypertension, atherosclerosis, dyslipidemia, and chronic kidney disease. The CMHC agenda, faculty, and general congress information can be found at
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Tags: Annual Meeting, Chronic Kidney Disease, Clinicians, Cmhc, Diabetes, Dyslipidemia, Educational Sessions, Health Congress, Hypertension, Management Of Diabetes, Obesity, Prevention, Risk, Sheraton Boston Hotel, Sheraton Hotel
22 Sep 08 3rd Annual Cardiometabolic Health Congress, Boston
The 2008 Cardiometabolic Health Congress (CMHC) will hold its third annual meeting October 15-18, 2008, at the Sheraton Boston Hotel. Over 1,000 clinicians will attend educational sessions focusing on cardiometabolic risk, including the prevention and management of diabetes, obesity, hypertension, atherosclerosis, dyslipidemia, and chronic kidney disease. The CMHC agenda, faculty, and general congress information can be found at
(more…)
Tags: Annual Meeting, Chronic Kidney Disease, Clinicians, Cmhc, Diabetes, Dyslipidemia, Educational Sessions, Health Congress, Hypertension, Management Of Diabetes, Obesity, Prevention, Risk, Sheraton Boston Hotel, Sheraton Hotel
16 Sep 08 Kidney disease increases risk of complications (Reuters)
Reuters - Chronic kidney disease puts
hospitalized patients at increased risk for adverse events
related to potential lapses in patient safety, according to
data from the Veterans Health Administration.
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Tags: Adverse Events, Chronic Kidney Disease, Lapses, Patient Safety, Reuters, Risk, Veterans Health Administration
