Modeling Simulation Predicts Potential Negative Impact on U.S. Blood Supply if ESA Use Limited for Chemotherapy-Induced Anemia
ATLANTA, Dec. 10 /PRNewswire/ -- A new analysis presented today at the
American Society of Hematology (ASH) 49th Annual Meeting and Exposition
predicts that limiting the use of erythropoiesis-stimulating agents (ESAs)
for chemotherapy-induced anemia (CIA) would place considerable pressure on
Ortho Biotech to Submit Official Request for Reconsideration to CMS Regarding ESA Coverage Policy
- Request Provides CMS with New Scientific Evidence -
BRIDGEWATER, N.J., Nov. 8 /PRNewswire/ -- Ortho Biotech Products, L.P.,
the company that markets PROCRIT(R) (Epoetin alfa), today will formally
request that the Centers for Medicare and Medicaid Services (CMS)
reconsider its final ...
Students from UAB and UPC will experiment under microgravity conditions at the ESA
A group of postgraduate students belonging to the Technical University of Catalonia (UPC) and Universitat Autnoma de Barcelona (UAB) were chosen by the European Space Agency (ESA) to design and carry out a scientific experiment under microgravity conditions. They will be monitoring how interactio...
US Oncology Reports Second Quarter Operating Results
...risk management in this offering, as well as lower esa
drug volumes. Pharmaceutical services EBITDA was ...ing criteria for reimbursement by Medicare for the esa
usage issued on July 30, 2007. Unlike the NCD f...st, 2008. The REMS is expected to focus on future esa
prescribing guidelines and may require additional ...
Nephrologists Indicate High Interest in AMAG Pharmaceuticals' Newly Approved Feraheme According to Latest BioTrends Report
... their current regimen. According to the survey, the need for new phosphate binders and PTH modifiers is relatively high compared to the need for new esa
and IV iron therapies. Particularly in the phosphate binder market, there are a number of important product attributes where current products fall sh...
DaVita Study Demonstrates Clinical Application of Sysmex Reticulocyte Hemoglobin Equivalent (RET-He) Parameter
...an's ability to make informed dosing decisions for esa
and IV iron therapy.
According to Dr. Van Wyc...oing dialysis."
Over the course of the study, esa
doses were held constant and IV iron therapy was w...Hb (Ret-H e or CHr) were useful analytes to guide esa
and IV iron therapy, whereas ferritin and TSAT wer...
SMOS ready to ship to launch site
...ns and preparations for the launch campaign.
Following the final review, the Flight Acceptance Review Board, which comprised senior managers from esa
and the French Space Agency CNES, were satisfied that all these elements are in good order and have signed the 'consent to ship' documentation. After ...
Retrospective Analysis Finds Treatment of Cancer Chemotherapy Patients With Epoetin Alfa Associated With Lower Drug Cost Than Darbepoetin Alfa
...timulating agents (ESAs) found that the cumulative esa
cost with Epoetin alfa (EPO) was 29 percent lower ... current real-world dosing patterns and associated esa
costs in an adult cancer chemotherapy population. The data showed that the cumulative esa
cost was $4,321 for patients receiving EPO vs. $6,...
ESA's Corona(R) Family of HPLC Detectors, Including the New Corona ultra(TM), Can Now be Controlled by Waters Empower(R) 2 Chromatography Software
...orona detector instrument-control software driver. esa
Biosciences, Inc., a Magellan Biosciences company ... labs, since so many have standardized on both the esa
Corona and Waters platforms. Customers asked for i...ation, visit www.corona-ultra.com .
Life Science Tools ( www.esainc.com )
Product Shifts are Occurring in the Renal Anemia and Bone and Mineral Metabolism Markets According to the Most Recent TreatmentTrends(R): US Nephrology Report from BioTrends Research Group
...Group, Inc. released TreatmentTrends(R): US Nephrology, a syndicated report based on online survey results from over 200 US Nephrologists.
In the esa
market, changes that have occurred seem to have taken place at the product level, while the overall use of ESAs has remained stable compared to the sa...
ESA in Medical Technology
New Data Highlighting Possible Impact of ESA Reimbursement Policies on Patient Care, Nation's Blood Supply, to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting
BRIDGEWATER, N.J., May 16 /PRNewswire/ -- Data from three studies
evaluating associations between lower mean baseline hemoglobin (Hb) levels
and the rate of blood transfusions, as well as the possible effect of
restrictions on reimbursement for erythropoiesis-stimulating agents (ESAs)
New Studies Presented at European Society of Anaesthesia Further Validate Masimo PVI(TM) for Noninvasive and Continuous Fluid Monitoring
...s a simple and cost-effective method for accurate, noninvasive, and continuous monitoring of fluid responsiveness. The three studies presented at the esa
reinforce the accuracy of PVI compared to invasive measures and highlight its value for before, during, and after anesthesia.
Does the Pleth Var...
Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion
...d with ESAs before and after implementation of the esa
coverage limitations," said study director Chris L... and treated with ESAs after implementation of the esa
NCD compared with before implementation of the esa
Study Methods and Results
New Meta-Analysis Confirms Safety Profile for NeoRecormon in Treating Anaemia in Cancer Patients
...nsistent with the risk observed in the erythropoiesis stimulating agent (ESA) class in general, known by Health Authorities and described in all esa
labels. There was no difference in the incidence of serious (4% vs. 3%) or fatal TEEs (1% vs. 1%) for the NeoRecormon and control groups resp...
Observational Studies Assess the Potential Impact of Limiting Erythropoiesis-Stimulating Agent Availability on Frequency of Blood Transfusions
...reported that lower
mean Hb levels achieved during esa
therapy were associated with increased
study of oncology patients who initiated esa
therapy at different baseline
Hb levels (Burton et... concluded that blood
utilization was greater when esa
therapy was initiated in patients who had
Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
...e group is about to generate
important new analyses regarding the safety of esa
use in CIA. The FDA
should consider these analyses before making its final ...eased mortality observed in studies with high
hemoglobin (Hb) targets. When esa
use is targeted to Hb higher than 12
grams per deciliter of blood (g/dL), t...
Totality of Available Data Reaffirms PROCRIT(R) (Epoetin alfa) Is Safe and Effective When Used Appropriately as Labeled to Treat Chemotherapy-Induced Anemia
...d trials of ESAs to treat CIA. "The known
risks of esa
use are prominently displayed in the current produ...ch, along with
independent investigators and other esa
manufacturers, has provided data to
the independen...tients, making it the largest combined analysis of esa
safety data ever
undertaken. The company also has ...
Observational Data Show Transfusion Patterns in Chemotherapy-Induced Anemia Patients Receiving Erythropoiesis-Stimulating Agents
...icate that the
presence of a lower hemoglobin when esa
therapy was initiated was
associated with a higher...eated oncology patients that received at least
doses. Results of the analysis were as follows:
...py-treated patients received transfusions when esa
treatment was initiated at Hb levels below 10 ...
PROCRIT(R) (Epoetin Alfa) Data to be Presented at American Society of Hematology Annual Meeting
...n the Potential Impact on Blood Supply of Limiting esa
-- Poster: Impac... recent safety concerns from studies with another esa
in cancer patients not receiving CT or RT, enr...tin alfa and darbepoetin alfa dosing patterns, esa
treatment costs and red blood cell transfusion...
Oncologists Call For Medicare to Reconsider Anemia Drug Restrictions
...fortunately, what FDA considers safe
and effective esa
use, CMS does not. As a result, our Medicare patie...e standard of care as our younger patients."
labeling revisions include additional warnings rel... CMS NCD, on the other hand, arbitrarily prohibits esa
hemoglobin levels are 10 g/dL or higher.
ESA in Biological News
Symposium to discuss geoengineering to fight climate change at the ESA Annual Meeting
Geoengineering techniques aim to slow global warming through the use of human-made changes to the Earth's land, seas or atmosphere. But new research shows that the use of geoengineering to do environmental good may cause other environmental harm. In a symposium at the Ecological Society of America...
Sustainable agriculture at the ESA Annual Meeting
Advances in ecology increasingly reveal that conventional agricultural practices have detrimental effects on the landscape ecology, creating problems for long-term sustainability of crops. In a series of sessions at the Ecological Society of America's Annual Meeting, ecologists will present their ...
Animal and plant communication at the ESA Annual Meeting
Animals and plants communicate with one another in a variety of ways: behavior, body patterns, and even chemistry. In a series of talks at the Ecological Society of America's annual meeting, to be held August 3-7 in Albuquerque, New Mexico, ecologists explore the myriad adaptations for exchanging ...
Urban water ecology at the ESA annual meeting
Increasingly, human urban development overlaps with habitat for wild animals and plants, creating environments that degrade natural landscapes. But people, animals and plants all have in common the need for healthy, sustainable freshwater ecosystems. In a series of presentations at the Ecological ...
Highlights from the March editions of ESA journals
The press tips below highlight research in the ESA
journals Frontiers in Ecology and the Environment , Ecology , Ecological Applications and Ecological Monographs .
1. Fuel removal and prescribed burns reduce wildfire severity but may invite invasives
Almond pest management team to receive major award at ESA meeting
DAVIS--A University of California team that developed a successful insect pest management program for almond growers, leading to significant pesticide reduction, will be honored at the Entomological Society of America (ESA) annual meeting, Nov. 16-19 in Reno.
The seven-member Almond Pest Mana...
Colony collapse disorder symposium added to ESA Annual Meeting
Lanham, MD; October 17, 2007A late-breaking symposium, Colony Collapse Disorder in Honey Bees: Insight Into Status, Potential Causes, and Preventive Measures, has recently been added to the 55th Annual Meeting of the Entomological Society of America (ESA), to be held in San Diego, December 9-12. T...
Wisconsin Governor Jim Doyle to receive Regional Policy Award from ESA
Gov. Jim Doyle will be the first recipient of a prestigious award given by the nation's largest group of ecologists at the 93rd Annual Meeting of the Ecological Society of America on August 3. The award recognizes a regional or local policymaker who has an outstanding record of informing their pol...
Europe and China watching Earth together
...ongoing Dragon 2 research projects using data from esa
and Chinese Earth observation satellites.
Dragon 2 a joint undertaking between esa
and the Ministry of Science and Technology (MOST) ...irst phase of Dragon developed the exploitation of esa
EO data in China via joint projects led by Chinese...
World Day to Combat Desertification focuses on human security
... essential to monitor the areas most at risk.
has been working closely with the UNCCD secretaria...processes and their trends over time.
In 2004, esa
launched a large pilot project called DesertWatch ... used to satisfy UNCCD reporting requirements.
is currently preparing an extension to DesertWatch...
ESA in Biological Technology
Magellan Diagnostic Businesses to Feature Automated Systems and Diagnostic Tests at Clinical Lab Expo
..., visit www.dynextechnologies.com .
Life Sciences will feature its FDA-cleared test t...ficant improvements over other methodologies. The esa
Biosciences Vitamin D Test , comprising reagent ki...ficity issues associated with existing assays. The esa
test provides accurate and specific results as dem...
Amgen's Fourth Quarter 2008 Adjusted Earnings Per Share Increased 6 Percent to $1.06; Full Year 2008 Adjusted Earnings Per Share Increased 6 Percent to $4.55
...ter of 2007 due to changes in foreign exchange which negatively impacted fourth quarter 2008 sales by approximately $12 million, pricing pressure, and esa
(erythropoiesis stimulating agent) dosing conservatism in our oncology business. Excluding the impact of foreign exchange, worldwide product sales de...
BioTrends Releases TreatmentTrends(TM): US Nephrology, an Ongoing Syndicated Publication Providing Insight into Physician Perceptions and Management of Renal Anemia, Hyperphosphatemia, and Secondary Hyperparathyroidism
...ntly leads the dialysis market and Ortho Biotech's Procrit and Amgen's Aranesp virtually split the CKD market. Even though the perceived need for new esa
therapies is relatively low, ESAs with extended dosing intervals are desired in CKD and ESAs with less hemoglobin variability are desired in dialysis....
European Nephrologists Share Insights on the Management of Renal Anemia and Hyperphosphatemia in Latest BioTrends Report
...is on the management of renal anemia and hyperphosphatemia.
In the esa
market, Amgen's Aranesp is the market share leader in both dialysis and CKD... differences between biosimilar ESAs and their reference brands. Projected esa
share growth is most favorable for Roche's Mircera, particularly in France ...
BioTrends Releases TreatmentTrends(TM): Nephrology and Renal Dietitians, Two Syndicated Reports Providing Continuing Insight into the Management of Renal Anemia, Hyperphosphatemia, and Secondary Hyperparathyroidism
..., lower target hemoglobin levels, lower levels
initiation, holds, and dose reductions) and more t...ephrologists do not predict significant changes
market share in CKD or dialysis in the near-term, ...ey do
project that bundling will have an impact on esa
use most likely through
shifts to subcutaneous dos...
Amgen's Third Quarter 2008 Adjusted Earnings Per Share Increased 14 Percent to $1.23
... changes in foreign exchange
which positively impacted third quarter 2008 sales by approximately $35
million, partially offset by pricing pressure and esa
stimulating agent) dosing conservatism versus the prior year. Excluding the
impact of foreign exchange, international product sales de...
New Study by BioTrends Highlights Anemia Practice Patterns According to Anemia Managers in Both Dialysis Units and CKD Clinics/Offices
... very involved in monitoring
lab values related to esa
and IV iron use and making therapy decisions
based..., the vast majority of
Anemia Managers report that esa
safety issues have impacted their use of
ESAs in d...phrologists most often report
protocol changes and esa
dose reductions at lower hemoglobin levels as
ESA Receives 2008 Frost & Sullivan North American Technology Innovation Award for Development of Integrated Metabolomics Systems
... CHELMSFORD, Mass., Sept. 3 /PRNewswire/ -- esa
Biosciences, a Magellan
Biosciences company and le...-metabolite study. In these
areas and many others, esa
is making a substantial contribution to advance
"The Frost & Sullivan Innovation Award comes as esa
metabolomics work made possible by a...
NPL to create 'encyclopedia for space nanomaterials'
... she explains.
The NPL led consortium will help esa
to identify nanomaterials companies with potential...tium's report is due in August 2009. It will allow esa
to review potential applications of nanomaterials ...nos Stavrinidis, Head of Mechanical Engineering at esa
explained that NPL won the contract for its long s...
BioTrends Releases Quarterly TreatmentTrends(TM): Nephrology Report Highlighting Market Trends for Renal Anemia, Hyperphosphatemia, and Secondary Hyperparathyroidism
...t of Stage 3 and Stage 4 CKD patients treated with ESAs compared to
the previous year. And, approximately one-third of Nephrologists report
that their esa
use has decreased specifically due to managed care policies.
While there have been no significant changes in market share year over year