|
HDCN News Archive -- Anemia |
|---|
| J11 |
FDA lists May 2008 labeling changes: Aranesp (tumor progression) and CellCept (lymphoma and PML risk) |
| J09 |
Fresenius signs sublicensing agreement with Luitpold to use Venofer in United States patients. |
| J03 |
Secondary analysis of CHOIR data suggests that high EPO doses, rather than high Hb per se, associated with mortality. |
| J28 |
Bill to approve pathway for FDA approvals of biosimilars advocated as saving billions of dollars. |
| J26 |
Testing of athletes for illicit EPO use has high rate of false negatives. |
| M27 |
AMAG Pharmaceuticals signs agreement with 3SBio to commercialize ferumoxytol in China. |
| M21 |
Former Amgen executive Dr. Robert Brenner moves to AMAG. |
| M21 |
Protein structure is deciphered of steap3, a protein that regulates iron absorption in the gut. |
| M06 |
PNAS: Erythropoietin promoter polymorphisms associated with diabetic retinopathy and progression to ESRD. |
| M05 |
ASN Renal Week abstract archives 2003-2006 now available on-line in .pdf format. |
| A28 |
New JAMA study to highlight CV risk of blood substitutes; FDA under renewed pressure. |
| A15 |
CMS adopts 26 new CPMs effective April 1, 2008 |
| A13 |
Genetic mutation causes iron-resistant iron-deficiency anemia by turning on hepcidin. |
| A04 |
AMAG Pharma presents data on new iron supplement at NKF Spring Clinical Meeting. |
| A04 |
Affymax presents Phase 2 Hematide data at NKF Spring Clinical Meeting in Dallas. |
| M27 |
U.S. judge seeks expert advice on Amgen-Roche license. |
| M20 |
Vitamin C recycling in human red cells explained via glut-1. |
| M20 |
Two week old blood associated with adverse outcomes when transfused. |
| M19 |
Update: Court sends Roche/Amgen patent dispute back to the International Trade Commission. |
| M19 |
Colorectal cancer cells found to produce hepcidin. |
| M13 |
FDA Oncologic Drug Advisory Panel recommends continued indication of ESAs for cancer patients excluding breast and head and neck. |
| M11 |
FDA advisory committee to meet Thursday to discuss use of ESAs in cancer. |
| M11 |
FDA releases briefing document for Oncologic Drug Advisory Committee on ESAs in cancer. |
| M08 |
Ortho Biotech and Amgen modify black box ESA warnings to reflect DVT, tumor progression risk. |
| M05 |
The source of blood stem cells found - it's the placenta. |
| F26 |
JAMA: Meta-analysis finds increased risk of death and venous thrombosis with ESA use in cancer patients. |
| F25 |
AJKD editorial: Need for placebo controlled trials in ESA use. |
| F20 |
AMAG submits NDA to FDA for ferumoxytol. |
| F20 |
New mechanism of hypoxia-induced blood vessel growth identified. |
| F07 |
Hereditary hemochromatosis gene found to act in the liver via modulating hepcidin production. |
| J29 |
BioTrends reports on its survey of changing practice patterns in treating anemia and mineral bone disorder. |
| J28 |
New promising technique uses selectin-coated intravascular probe to collect blood-borne stem cells. |
| J22 |
Gene affecting ribosome function found to cause anemia of myelodysplasia. |
| J17 |
Hereditary hemochromatosis genotype more common than previously thought: 1 in 250. |
| J11 |
Gas6 protein may augment the action of erythropoietin |
| J03 |
FDA receives new data on risks of ESAs in cancer patients, relating to growth rate of certain tumors. |
| D21 |
Animal study suggests that EPO may protect hearts against toxicity of anticancer drugs |
| D19 |
AMAG pharma submits new drug application to FDA for ferumoxytol. |
| D14 |
FDA warns of serious adverse reactions with iron chelator Exjade. |
| D10 |
American Hematology Society 2007 abstracts now available. |
| D10 |
ESAs linked to leukemic transformation in patients with myelofibrosis. |
| D08 |
Strategies for surgery in Jehovah's Witness patients to avoid transfusion. |
| D04 |
FDA approves study of iron-containing dialysate additive for hemodialysis patients. |
| N26 |
RBC transfusions linked to increased risk of heart attack and stroke in cardiac surgery patients. |
| N14 |
Hemoglobin variability predicts mortality in dialysis patients |
| N08 |
Link to new FDA boxed labels for ESAs. Their target Hb range is 10-12 g/dL. |
| N08 |
FDA modified boxed warnings, indications, for ESA drugs. |
| N08 |
Hematide found to restore blood in aplasia patients. |
| N05 |
New vascular function of hemoglobin, as a promoter of nitric oxide synthesis, identified. |
| O23 |
Amgen wins crucial patent ruling over Roche. |
| O19 |
For cancer patients, Aetna will no longer reimburse for epogen unless Hb falls below 10 unless patient is symptomatic. |
| O18 |
Roche states that U.S. Mircera plans depends on outcome of court case. |
| O08 |
Two studies emphasize importance of nitric oxide in red blood cells, and absence of NO in banked blood. |
| S21 |
Low on EPO: Just scratch your head. Hair follicles found to make EPO. |
| S20 |
Rockwell begins enrollment into Phase IIIb trial of dialysate sodium ferric pyrophosphate for iron therapy. |
| S18 |
Representative Pete Stark writes about Epogen reimbursement policy on his blog. |
| S17 |
Dr. Joseph Eschbach: in memoriam |
| S12 |
FDA advisory panel rejects idea of setting 11 g/dL as the upper limit of target Hb with ESAs. |
| S10 |
Agenda for Sept. 11th FDA Advisory Panel Meeting (.pdf) concerning Hb targets for ESA drugs. |
| S10 |
FDA Advisory Panel to meet September 11th to reconsider Hb targets. |
| S06 |
NEJM: Procrit use in ICU patients appears to improve survival, but increases risk of thrombotic events. |
| S03 |
Sheet Metal Workers health plan sues DaVita, Amgen, and Fresenius in a civil action claiming overuse of EPO. |
| A31 |
NKF KDOQI anemia guideline update released - sets upper Hb limit at 12 g/dL in most cases. |
| A29 |
U.S. Court rules that Roche's pegylated EPO infringes on one of Amgen's patents. |
| A27 |
Economic issues relating to EPO usage - 5 full text articles from AJKD, September, 2007 |
| J31 |
CMS releases new coverage guidelines for ESAs when used for non-renal indications. |
| J26 |
Roche wins EU approval for anemia drug Mircera. |
| J24 |
Ferumoxytol Phase III clinical trial results achieve desired endpoints. |
| J23 |
CMS releases modified reimbursement policy for ESAs. Dosage reduction moves from 25 to 50% when Hb greater than 13. |
| J20 |
More on new CMS billing requirements on ESAs from MLN matters. |
| J20 |
CMS: Line item billing requirement for ESAs in program manual update. |
| J16 |
Affymax announces phase 3 development program for Hematide. |
| J26 |
GAO proposes bundled payment for all ESRD services |
| J20 |
vHL factor may be important in regulating iron metabolism and anemia |
| J05 |
Amgen buys Ilypsa - a company with a novel phosphate-binding drug for CKD |
| M25 |
Rockwell gets Japanese patent for dialysis solution iron delivery. |
| M25 |
Roche's Mircera gets preliminary approval in Europe for treating renal anemia. |
| M23 |
Medicare issues proposed coverage decision to limit payment for ESAs in patients with cancer. |
| M23 |
Iron-chelating agent defasirox (Exjade) associated with acute renal failure. |
| M21 |
More on the FDA approvable letter on Mircera |
| M21 |
Roche receives approvable letter for Mircera in the United States. |
| M11 |
Report on FDA panel meeting looking into safety of ESA drugs in cancer treatment. |
| M10 |
FDA meeting focuses on possibility of increased tumor risk with some ESAs. |
| M10 |
Affymax data presented at ISN World Congress in Rio. |
| M09 |
(Apparently legal) payments to doctors to prescribe anemia drugs in the news. |
| A18 |
JAMA: EPO utilization higher in certain for-profit dialysis chains. |
| A13 |
New NKF anemia guidelines could hurt ESA sales. |
| A12 |
NKF releases preliminary anemia guideline update |
| A02 |
Ceprotin gets FDA approval to treat purpura fulminans. |
| A02 |
Scientists change one blood group into another. |
| M16 |
Medicare to review payment policies for ESAs in view of FDA black box warning |
| M16 |
Substituting gallium for iron impedes growth of slime-forming bacteria. |
| M11 |
Another FDA link to the new Epogen/Procrit/Aranesp labels with black box warnings. |
| M10 |
Links to FDA advisory on ESA drugs. |
| M09 |
FDA to require black box warnings on ESAs regarding complications associated with higher Hbs. |
| F28 |
Nifedipine found to mobilize liver iron stores in an animal model of hemochromatosis. |
| F19 |
FDA Medwatch issues drug advisory on ESA use in cancer patients. |
| F04 |
Limit Hb to 12 g/dL in dialysis patients? Not so fast! (New study from Europe suggests that 13-15 g/dL may be OK if not better) |
| F02 |
The politics and cost issues relating to EPO in the news |
| F01 |
Biotrends report of Dec 2006 survey on use of ESAs and phosphate binders. |
| F01 |
JASN: DRIVE study published: shows beneficial effects of giving IV iron when serum ferritin is high. |
| J08 |
FDA posts patient movie clip on its site about the potential CV risks of higher Hb levels. |
| D31 |
Gene knockout technology creates healthy, prion-protein-free cows |
| D29 |
Boston docs lower anemia targets in response to CHOIR study. |
| D28 |
Advanced Magnetics stock surges on hopes for ferumoxytol. |
| D22 |
Prion-binding protein successfully removed variant CJD prions from banked animal blood. |
| D14 |
AJKD: Some chains adjust EPO doses more diligently than others when Hb values are high. |
| D12 |
New EPO-like drug mimics action of thrombopoietin: designed to treat thrombocytopenia. |
| D10 |
Three cases of vCJD (mad cow) disease transmitted by blood transfusion in the UK. |
| D07 |
ESA use hearing at House Ways and Means Committee in the News (New York Times) |
| D06 |
GAO report on bundling Medicare's payment for drugs with all ESRD services (pdf). |
| N30 |
Gene identified that permits GI absorption of folate; same gene involved in iron uptake. |
| N30 |
House Ways and Means committee schedules hearing (viewable on the internet) on anemia drug safety for December 6th. |
| N30 |
NKF to create panel of experts to evaluate safety of EPO-type drugs; story in major newspapers today. |
| N26 |
HDCN: Search index updated for audiofiles, slide/audio talks, articles, and abstracts |
| N19 |
Vitamin E coated dialyzers result in higher Hb values in dialysis patients. |
| N16 |
NEJM: CHOIR study. Hb targets 11.3 vs. 13.5. Risk ratio 1.34 in high-Hb group. |
| N16 |
NEJM: CREATE study: (GFR 15-35) Hb 10.5-11.5 vs. 13-15; no benefits of higher Hb target. |
| N16 |
Two anemia studies: CHOIR and CREATE published in NEJM today are raising regulatory concerns. |
| N09 |
Nephrologist expresses concern about high Hct levels; CHOIR study to be published this month. |
| O31 |
Shire launches phase IIIB study of epoetin delta. |
| S29 |
US OIG (Office of the Inspector General) upcoming audits to focus on EPO (p. 26, PDF) |
| S26 |
Affymax published initial phase 1 results of Hematide in improving reticulocyte count in healthy volunteers. |
| S14 |
Judge fast tracks patent infringement suit against Roche by Amgen |
| S11 |
Advanced Magnetic (ferumoxytol) hires Brenner, Salem, in top positions |
| S06 |
Advanced Magnetics completes enrollment for phase 3 trial of ferumoxytol IV iron. |
| J24 |
Rockwell gearing up to study efficacy of dialysis solution-based iron therapy. |
| J18 |
EDTA-ERA: Roche CERA effective for anemia with once-a-month dosing. |
| J29 |
Affymax and Takeda in joint venture to commercialize Hematide |
| J16 |
Shire's ESA drug DYNEPO reports good results in CKD patients |
| J16 |
CARI (Australasian) Clinical Practice Guidelines published (53 free full text review papers!) |
| M09 |
U.S. International Trade Commission (ITC) agrees to evaluate Amgen's complaint against Roche's importation of CERA in to the US. |
| M01 |
Astellas acquires rights to two new orally-active prolyl hydroxylase inhibitor drugs to treat anemia. |
| A25 |
Data from CHOIR study showed higher mortality with Hgb of 13 vs. Hgb of 11.5. |
| A21 |
Orally available iron chelating agent desafirox shows promising results. |
| A20 |
Roche files with FDA for approval of its anemia drug CERA (continuous erythropoetin receptor activator) |
| A19 |
Rockwell gets European patent for dialysate iron delivery product. |
| A13 |
Trial launched to study use of Hematide (non-EPO anemia drug) in patients with PRCA. |
| A12 |
Roche fights back over CERA - FDA application plans in the works. |
| M24 |
Too much iron in the brain? Brain ferritin measured by MRI (in nonuremics) |
| M22 |
New CMS EPO and Aranesp payment policy in effect after April 1, 2006 - Listen to conference call. |
| F21 |
Advanced Magnetics continues phase III trial of ferumoxytol. |
| F06 |
Rockwell Medical raises 9.5 M to fund approval process of ferric pyrophosphate additive. |
| F05 |
New interest in possible neutralizing antibodies to EPO as cause for refractory anemia |
| J26 |
Gatekeeper protein discovered that keeps platelets from clotting. |
| J11 |
Amgen Nephrology Institute established - requesting grant proposals. |
| J09 |
New iron chelator more effective than desferoxamine. |
| D25 |
In vitro gene therapy introduces normal globin genes into sickle cell patient stem cells. |
| D12 |
AMG531 (Amgen drug) increases platelet count in patients with ITP. |
| D08 |
Affymax to present peptide ESA results at hematology meeting. |
| N18 |
Rockwell Medical appoints Scientific Advisory Board |
| N16 |
Brian Pereira named president of Advanced Magnetics |
| N13 |
CERA phase II results presented at ASN: Report good control of anemia. |
| N10 |
FDA approves deferasirox - first oral drug to treat iron overload. |
| N07 |
Four abstracts on new Roche anemia drug CERA to be shown at ASN. |
| N05 |
AJKD: Canadian RCT fails to show benefit of EPO on LVMI in primary analysis. |
| O31 |
Pall blood filter touted to remove prions from donated blood. |
| O26 |
ASN Renal Week 2005 abstracts now available on-line. |
| O11 |
Transcription of ferritin gene related to iron, heme, and antioxidants. |
| O10 |
RBC secretion of s-nitrosothiol regulates vascular (esp. pulmonary) tone. |
| S11 |
New duodenal iron transport system identified for haem iron absorption. |
| A24 |
NEJM: EPO associated with proliferative retinopathy in patients and mice. |
| A18 |
Researchers discover new pathway to hemoglobin synthesis. |
| A16 |
Cardiologists confirm anemia - mortality link in CHF patients. |
| A16 |
Mayo researchers link mortality in ESRD to high levels of heparin antibodies. |
| A11 |
Rockwell awarded European patent for new iron delivery technology. |
| J14 |
New super-EPO (PT-401) drug under development. |
| J22 |
Venofer gets FDA approval for treatment of pre-dialysis (CKD) patients. |
| J11 |
Affymax announces good results with peptide-based ESA to treat anemia. |
| J06 |
CERA anemia drug shows promising results in longer-term trial. |
| M20 |
JASN: New European RCT of Hgb normalization shows no harm but no benefit for LV. |
| M20 |
Which patients should be screened for hemochromatosis? |
| M20 |
Amgen, J and J, drugs compete in data reported at oncology conference. |
| A08 |
Phase 2 trial of Affymax to treat anemia begins. |
| A06 |
JNCI study examines effect of EPO on survival in cancer patients. |
| F09 |
NEJM: Anti-angiogenesis drug useful to treat myelodysplastic syndrome. |
| J19 |
Amgen's next blockbuster drug - for osteoporosis. |
| J14 |
Amgen adds warning about risks of higher hemoglobin doses. |
| J13 |
Advanced Magnetics initiates large-scale trial of ferumoxytol IV iron. |
| J05 |
JAMA review: Cytoprotective effects of EPO. |
| J04 |
Long-term NSAID use linked to small intestinal damage, bleeding. |
| D17 |
Self-screening fingerstick test for anemia being marketed to CKD patients. |
| D16 |
ANNA: Learning module, PPT files, CE on Hemodialysis |
| D08 |
Amgen announces 5 billion dollar stock repurchase plan |
| D08 |
Affymax presents animal data on effectiveness of ESAs for erythropoiesis |
| N29 |
Blood product study sparks informed consent debate |
| N03 |
Research confirms that mad cow disease prions can be removed from blood |
| N03 |
Transmission of mad cow disease by transfusion leads to fears of a second wave |
| N01 |
ASN: Stable Hb levels with q4week dosing using CERA |
| O28 |
New discoveries show how hepcidin/ferroportin regulate Fe absorption in the gut |
| O27 |
Normal serum B12 levels may mask B12 deficiency |
| O26 |
Rockwell progressing through preclinical evaluation of dialysate FePPi |
| O26 |
KDIGO.org website now up for international kidney disease guidelines |
| O25 |
Iron-deficient brain cells linked to restless legs syndrome in non-ESRD patients |
| O02 |
Blood doping test detects presence of recent transfusion |
| S30 |
NEJM: Aplastic anemia due to Eprex down by 80% |
| S21 |
Aranesp (darbepoetin) approved for q 3 week dosing in Europe |
| S14 |
RoFar grant deadline (second round) is 21 Nov, 2004 |
| A06 |
Aranesp obtains positive regulatory opinion in Europe for extended dosing |
| J26 |
Maker of ferrumoxytol appoints Brian Pereira to Board of Directors |
| J13 |
Early EPO Rx slows progression of CKD in randomized trial |
| J09 |
Chemically modified EPO shows tissue protective effects |
| J21 |
JUNE 30th deadline for letter of intent for Roche Anemia Foundation grants |
| J12 |
Seminars publishes paper questioning survival benefits of higher EPO doses |
| M19 |
Roche funds new international foundation for anemia research |
| A30 |
Ferrumoxytol Phase 2 results presented at NKF Clinical Meeting in Chicago |
| A27 |
Advanced Magnetics begins phase III trials of ferumoxytol IV iron |
| A21 |
Bioarcheology of hemoglobin in primitive bacteria |
| A20 |
Mild iron deficiency in women impairs memory, attention, and learning |
| A19 |
Hepcidin linked to anemia of chronic disease |
| M11 |
PEG-coated Hgb may result in an artificial blood that actually works |
| F09 |
Amgen dazzles Seattle with 10 M double-helix footbridge for its workers |
| D22 |
Mad cow disease transmitted via blood transfusion in Britain |
| D08 |
Thalidomide-like drug useful in treating anemia of myelodysplastic syndrome |
| D02 |
Hemoglobin-based substitute shows promising early results |
| D01 |
Estrogen plays a key role in megakaryocytes in promoting formation of platelets |
| N07 |
Mutations in ferroportin gene can cause primary iron overload |
| N03 |
Medicare payment for Amgen's Aranesp to rise |
| O23 |
Powdered artificial blood given to patients - just add water |
| O13 |
Androgens and other EPO alternatives to treat ESRD anemia |
| S19 |
Europeans question why industry funded trial of NAC for anemia was stopped |
| S18 |
Time-averaged Hgb differs from predialysis Hgb - a more rational EPO target |
| S18 |
Zebrafish tail gene linked to red blood cell formation |
| S17 |
Amgen expanding in a difficult economy |
| S12 |
UDP galactose preserves the life of chilled platelets |
| S08 |
Amgen and Biovitrum to develop novel anti-diabetic compounds |
| A08 |
Oral heme iron seems to work in a substantial percent of HD patients |
| A07 |
Possible plasticizer risk from blood stored in PVC bags: Iranian study |
| J25 |
Anemia associated with physical decline in the elderly |
| J22 |
Amgen's Q2 profit rises on strong sales of arthritis, cancer drugs |
| J22 |
Epogen counterfeiters in Florida are indicted |
| M30 |
Vitamin C use leads to reduction in EPO dose in ESRD |
| M14 |
Medicare reconsiders reimbursement cut for ARANESP |
| M11 |
FDA warns that counterfeit Procrit poses a serious hazard |
| F16 |
Georgia blood bags exonerated - not responsible for particulate matter |
| F15 |
Amgen and Transkaryotic fight over EPO patent rights in United Kingdom |
| F01 |
FDA Patient Safety webcast: Rapid HIV test; Counterfeiting of Procrit; |
| J25 |
J&J - Amgen dispute: Procrit sales to continue, J&J to pay Amgen legal fees |
| J25 |
Anemia in CHF: True anemia or hemodilution? |
| J24 |
Archived conference call discusses Amgen's products, prospects, Q4 results |
| J15 |
Iron gene, iron overload, linked to colon cancer |
| J12 |
HDCN: Anemia channel talk list updated |
| J06 |
Amgen wins patent infringement suit ruling on appeal against Transkaryotic |
| D26 |
Court dismisses Amgen reimbursement suit against Medicare |
| D13 |
Polyphenols in grape juice may inhibit oral iron absorption |
| N26 |
Treating anemia in cancer patients markedly improves quality of life |
| N15 |
Amgen files suit to seek relief from Aranesp reimbursement ruling |
| N09 |
Lawmakers question reimbursement cut for Aranesp |
| N02 |
Update on EPO antibodies and reactions presented at ASN 2002 |
| N01 |
Biotech company plans new gene therapy approach to treat
anemia |
| O18 |
J & J told to pay Amgen 150 million regarding dialysis unit sales of
EPO |
| O15 |
J and J, maker of Procrit and Eprex, posts strong increase in Q3 earnings |
| O12 |
Swallowed mini-camera helps diagnose GI pathology |
| O10 |
Blood test for mad cow disease may be near |
| O02 |
New method of sterilizing blood products close to launch |
| A20 |
Randomized trial supports use of darbepoetin alfa in anemic cancer patients |
| A07 |
B12-related anemia may be subtle and not
macrocytic |
| A04 |
Blood transfusions linked to Creutzfeld-Jakob disease |
| J04 |
Questionnaire tests home caregivers for burnout |