Recent news on Darbepoetin Alfa

MIRCERA Receives Positive Opinion in Europe for the Treatment of ...  -  25 May 2007
Juraforum.de,Darbepoetin alfa was dosed once aweek or once every two weeks compared to CERA dosed once every twoweeks. - The fourth study (RUBRA) was designed to

APS: MIRCERA Receives Positive Opinion in Europe for the .........  -  25 May 2007
ANP Pers Support,Hb levels in CKD patients on dialysis previously maintained on IV darbepoetin alfa. epoetin. Epoetin was administered up to three times weekly compared to

FDA issues approvable letter for Roche's Mircera  -  May 21, 2007
Pharma Times (subscription),...of the warning labels on Amgen's ESAs, Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), as well as Johnson & Johnson's Procrit (also epoetin alfa).

EMEA to re-examine epoetins over cardiac fears  -  May 8, 2007
BiopharmaReporter.com,Several big pharma firms have epoetins on the market, such as Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa); Ortho Biotech's Eprex (epoetin

Aranesp® and Epoetin Alfa Do Not Increase Blood Clots in Ovarian ...  -  May 1, 2007
Cancer Consultants (press release),According to an article recently published in Gynecologic Oncology, use of Aranesp® (darbepoetin alfa) or epoetin alfa (Procrit® or Epogen®) does not appear

Amgen's US monopoly in EPO drugs may be close to its end  -  May 22, 2007
BiopharmaReporter.com,...medical professionals and patients about cases of severe anaemia in cancer patients taking Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).

FDA Sounds Alert on Anemia Drugs  -  May 1, 2007
Journal of American Medical Association (subscription),The FDA warning applies specifically to darbepoetin alfa (Aranesp, made by Amgen Inc, Thousand Oaks, Calif) and epoetin alfa (Epogen, made by Amgen,

In Cancer-Related Anemia Researchers Warn Caution In The Use Of ESAs  -  May 7, 2007
Medical News Today (press release),The ESAs darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit) are genetically engineered forms of a protein called erythropoietin,

News For Your Web Site  -  May 21, 2007
dBusinessNews Newark (press release),...anemia therapy to have compared itself in clinical trials against all commercially available agents: epoetin alfa, epoetin beta and darbepoetin alfa.

Amgen shares slide yet again over Medicare coverage cuts  -  May 16, 2007
Pharma Times (subscription),...a further strengthening of the warning labels on Amgen's erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa) and Epogen (epoetin alfa),

Amgen knocked back as EPO competition looms  -  May 17, 2007
BiopharmaReporter.com,Amgen is trying to prevent competition to Epogen and its other erythropoietin-based anaemia drug Aranesp (darbepoetin alfa) in the US, which together

Recommendations for Primary Care of the Patient With Cancer  -  Apr 30, 2007
Medscape (subscription)If hemoglobin level is less than 11 g/dL (110 g/L), the patient should be treated with recombinant erythropoietin (epoetin alfa or darbepoetin alfa).

Addition of IV Iron to Treatment with Red Blood Cell Booster May ...  -  May 7, 2007
Cancer Consultants (press release),In cancer patients, use of red blood cell boosters such as Aranesp® (darbepoetin alfa) and Procrit® (epoetin alfa) has been shown to decrease the need for

Kirin's NESP(R) Long-Acting Erythropoiesis Stimulating Agent ...  -  26 Apr 2007
Japan Corporate News (press release),...and marketing approval for its long-acting erythropoiesis stimulating agent Darbepoetin Alfa, brand name NESP(R) Injection Syringe, on April 18, 2007.

Darbepoetin Alfa Fails To Reduce The Need For Blood Transfusions ...  -  Apr 18, 2007
Medical News Today,Darbepoetin alfa (Aranesp) failed to significantly reduce the need for blood transfusions in patients with active cancer not being treated with chemotherapy

Anti-anemia drug darbepoetin alfa no better than placebo for ...  -  Apr 18, 2007
News-Medical.net,The drug, darbepoetin alfa (DA) is a synthetic form of erythropoietin, a hormone that signals the formation of new red blood cells from within the bone

AACR: No Benefit for Darbepoetin Alfa (Aranesp) in Cancer-Caused ...  -  Apr 17, 2007
MedPage Today,LOS ANGELES, April 17 -- Darbepoetin alfa (Aranesp) should not be used for treatment of anemia caused by cancer, researchers here reported.

Amgen earnings on the rise as Aranesp sales still grow  -  Apr 24, 2007
Pharma Times (subscription),Sales growth was once again driven by anaemia drug Aranesp (darbepoetin alfa) which increased 14% to just over $1.11 billion, while Epogen (epoetin alfa)

Amgen's First Quarter 2007 Revenue Increased 15 Percent to $3.7 ...  -  Apr 24, 2007
PharmaLive.com (press release),Worldwide sales of Aranesp(R) (darbepoetin alfa) increased 14 percent to $1020 million in the first quarter of 2007 versus $893 million during the first

Amgen Phase 3 Study Of Aranesp Fails To Meet Primary Endpoint ...  -  Apr 16, 2007
Trading Markets,3 study of Aranesp or darbepoetin alfa did not meet its primary endpoint of reducing red blood cell or RBC transfusions in the Aranesp treatment group.

Darbepoetin Associated With Increased Mortality in Cancer Patients ...  -  Apr 19, 2007
DG NewsLOS ANGELES, CA -- April 19, 2007 -- Cancer patients who have anaemia and are treated with darbepoetin alfa (Aranesp) have increased mortality rates

Aranesp(R) "145 Study" Shows No Difference In Survival In Patients ...  -  Apr 23, 2007
Medical News Today (press release),...(darbepoetin alfa) in 600 previously untreated patients with extensive-stage small-cell lung cancer (SCLC) receiving platinum-containing chemotherapy.

Aranesp linked to higher death rate in cancer trial  -  Apr 17, 2007
Pharma Times (subscription),As reported in January, Aranesp (darbepoetin alfa) failed to reduce the number of red blood cell transfusions in cancer patients not receiving chemotherapy

Amgen CFO walks away  -  Apr 11, 2007
BiopharmaReporter.com,...and reimbursement issues surrounding two of its leading drugs, Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) - both for the treatment of anaemia.

Data Analyses Outline Efficacy and Safety of MIRCERAâ„¢ for the ...  -  Apr 13, 2007
WebWire (press release),This was an overview of six global studies in approximately 2400 patients that compared MIRCERA with epoetin alfa or beta and with darbepoetin alfa.

Anemia After Kidney Transplant Worsens Outcomes  -  Apr 18, 2007
MedPage Today,Last month, the FDA issued a black box warning for erythropoiesis-stimulating agents, including darbepoetin alfa (Aranesp) and epoetin alfa (Epogen,

Amgen Announces Webcast of 2007 First Quarter Financial Results  -  Apr 11, 2007
PharmaLive.com (press release),...until April 23 to include the top line results of the Aranesp(R) (darbepoetin alfa) 145 study in small cell lung cancer patients receiving chemotherapy.

Biologic Anemia Drug Aranesp Falls Short in Trial, But Does Not ...  -  Apr 19, 2007
Biologic Drug Report,Results of the "145 study", a Phase 3 trial of Aranesp (darbepoetin alfa) in 600 previously untreated patients with extensive-stage small-cell lung cancer

Aranesp(R) Phase 3 Study In Patients With Active Cancer Not ...  -  Apr 19, 2007
Medical News Today (press release),Aranesp(R) (darbepoetin alfa) for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy ("the 103 study").

In Brief  -  Apr 3, 2007
Nature.com (subscription),In October 2006, a trial of Amgen's anemia drug Aranesp (darbepoetin alfa) was halted after an interim analysis showed it caused a statistically significant

Erythropoietin drugs: What to know about anemia-fighting medications  -  Mar 29, 2007
MayoClinic.comIncluded in the warning are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit). Here to answer some questions about erythropoietin and ESAs is

Aranesp ® Phase 3 Study in Patients with Active Cancer Not ...  -  Apr 16, 2007
Business Wire (press release),...of Aranesp ® (darbepoetin alfa) for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy (“the 103 study�).

Genentech financially strong while Amgen struggles  -  Apr 13, 2007
BiopharmaReporter.com,...for its leading anaemia drug Aranesp (darbepoetin alfa) - the study was halted in December, but the firm disclosed its failure three months later.

Billion dollar babies—biotech drugs as blockbusters  -  Apr 3, 2007
Nature.com (subscription),That's not a worry for Amgen, whose second-generation versions of these industry staples, Aranesp and Neulasta (darbepoetin alfa and PEG-filgrastim,

Aranesp® Every Two or Three Weeks as Effective as Weekly Schedule  -  27 Mar 2007
Cancer Consultants (press release),According to interim results from a multi-center clinical trial, Aranesp® (darbepoetin alfa) administered every two or three weeks is as effective as a

Epoetin Alfa May Decrease Survival in Anemic Patients with NSCLC  -  27 Mar 2007
Cancer Consultants (press release),...with the Food and Drug Administration (FDA) has released new guidelines on the use of epoetin alfa (Procrit®) and darbepoetin alfa (Ananesp®).

Amgen's Trial Of Vectibix Falls Short; ImClone Shares Benefit  -  Mar 25, 2007
BioWorld Online,The new warnings affected Aranesp (darbepoetin alfa), Epogen (epoetin alfa) and Epogen's counterpart, Procrit, which is marketed by New Brunswick,

Aranesp® Every 2 or 3 Weeks Confirmed as Effective as Weekly Schedule  -  Mar 12, 2007
Cancer Consultants (press release),Researchers involved in a multi-center trial have reported that Aranesp (darbepoetin alfa) administered every 2 or 3 weeks is as effective as a weekly

Revised Safety Information Approved for Aranesp, Epogen, and Procrit  -  Mar 13, 2007
Facts and Comparisons,The FDA has issued a public health advisory detailing new safety information for darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and )

Reps. Dingell, Stupak Call on Amgen, Johnson & Johnson to Suspend ...  -  Mar 22, 2007
PharmaLive.com (press release),...commonly known as EPO products, Epoetin alfa (marketed as Procrit, Epogen), and Darbepoetin alfa (marketed as Aranesp).

Black Box Warning Ordered for Aranesp, Epogen, and Procrit  -  Mar 9, 2007
MedPage Today,FDA action by instructing local Medicare carriers that it plans to deny reimbursement for darbepoetin alfa and epoetin alfa used for anemia of cancer,

Black Box Warning for Erythropoiesis-Stimulating Agents  -  Mar 12, 2007
Medscape (subscription)Darbepoetin alfa and epoetin alfa are indicated for the treatment of CRF-related anemia, and chemotherapy-related anemia in patients with nonmyeloid

FDA cracks down on anemia-drug use  -  Mar 10, 2007
Los Angeles Daily News,The drugs are darbepoetin alfa, sold as Aranesp by Amgen, and epoetin alfa, sold as Epogen by Amgen and as Procrit by Johnson & Johnson.

New York Times: Doctors in Bed with Big Pharma  -  Mar 21, 2007
Newsinferno.com,...warning earlier this month about erythropoiesis-stimulating agents (ESAs), including darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit).

Anemia drugs increase death risk  -  Mar 9, 2007
Food Consumer,The products are darbepoetin alfa and epoetin alfa. Darbepoetin alfa was approved for marketing on September 17, 2001 and is licensed and marketed by Amgen,

New Guidelines on the Use of Procrit® and Ananesp® Released by ASH ...  -  Mar 13, 2007
Cancer Consultants (press release),...with the Food and Drug Administration (FDA) has released new guidelines on the use of epoetin alfa (Procrit®) and darbepoetin alfa (Ananesp®).

Amgen Announces Update To US Prescribing Information For Aranesp ...  -  Mar 12, 2007
Safety Online (press release),...information for the class of drugs known as Erythropoiesis-stimulating Agents (ESAs), including Aranesp (darbepoetin alfa) and EPOGEN (Epoetin alfa).

Amgen, J&J warned by FDA over anaemia drug labelling  -  Mar 12, 2007
Pharma Times (subscription),...of Amgen's erythropoiesis-stimulating agents Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson's Procrit (also epoetin alfa).

Toll from crash of team bus rises to seven  -  Mar 9, 2007
St. Petersburg Times,The agency said that a "black box" warning - the strongest kind - had been added to the labels of darbepoetin alfa, sold as Aranesp by Amgen,

FDA Issues "Black-Box" Warnings Against Three Anemia Drugs  -  Mar 9, 2007
All Headline NewsThe drugs affected, known as erythropoiesis-stimulating agents or ESAs, are darbepoetin alfa (brand name Aranesp) and two epoetin alfa brands (Epogen and

FDA Tightens Warnings on Anemia Drugs  -  Mar 9, 2007
Persian Journal,The drugs included in the new safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). These drugs are genetically engineered

FDA Strengthens Warning on Drugs prescribed for Anemia in Cancer ...  -  Mar 9, 2007
Cancer Focus,The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). The FDA and the manufacturer of these products

FDA Updates Safety for Anemia Erythropoiesis-Stimulating Drugs  -  Mar 9, 2007
Playfuls.com,...a statement announcing the strenghtening of safety-related information in the drugs darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit).

Global Biotech Drug Market Grows by 17.9 Percent in 2006  -  Mar 23, 2007
Biologic Drug Report,Aranesp (darbepoetin alfa) was the 6th largest selling drug -- and the fastest growing of the leading drugs -- with global sales in 2006 of $5 billion.

Recruitment Temporarily Suspended Into CERA Phase II Oncology Trial  -  Feb 26, 2007
Medical News Today (press release),Patients are randomized to receive CERA 6.3µg/kg, 9µg/kg or 12µg/kg sc every 3 weeks or darbepoetin alfa according to the approved local label (either

Roche hurt by enrolment suspension in Mircera study  -  Feb 26, 2007
Pharma Times (subscription),...numerical imbalance in the number of deaths across the four arms of the study" (three arms with Mircera and one with darbepoetin alfa, Amgen's Aranesp).

NCCN Updates Cancer- and Treatment-Related Anemia Guidelines  -  Mar 5, 2007
Business Wire (press release),A significant issue the panel addressed was the results of a trial by Amgen, Inc. studying the use of Aranesp ® (darbepoetin alfa) in patients with

NCCN Updates Cancer- and Treatment-Related Anemia Guidelines  -  Mar 5, 2007
Genetic Engineering News (press release),A significant issue the panel addressed was the results of a trial by Amgen, Inc. studying the use of Aranesp(R) (darbepoetin alfa) in patients with

FDA Issues Advisory Regarding Use of Red-blood Cell Boosters  -  Mar 12, 2007
Cancer Consultants (press release),Erythropoiesis-stimulating agents include Procrit® (epoetin alfa) and Aranesp® (darbepoetin alfa). In cancer patients, use of medications to treat anemia

FDA - Black Box Warning on Anemia Drugs Epogen Procrit and Aranesp ...  -  Mar 12, 2007
Best Syndication,The drugs are Erythropoiesis-Stimulating Agents (ESAs) and include darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit).

FDA Strengthens Safety Information for Erythropoiesis-Stimulating ...  -  Mar 11, 2007
WebWire (press release),The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). (ESAs are genetically engineered forms of the

EPO Warning Nicks Amgen; Off-Label Risks Told Earlier  -  Mar 9, 2007
BioWorld Online,Some had worried that Aranesp (darbepoetin alfa) is given to patients with hemoglobin >13 g/dL, or begun at levels >12 g/dL, but Amgen's claim to the

FDA Warns of Serious Side Effects Related to Popular Anemia Drugs  -  Mar 9, 2007
Newsinferno.com,The warnings relate to darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). All three of the drugs are made by Amgen Inc., although Procrit is

NCCN Updates Myelodysplastic Syndromes (MDS) Guidelines  -  Feb 26, 2007
Business Wire (press release),One of the major changes to the 2007 version of the guidelines was the addition of darbepoetin alfa (Aranesp®, Amgen) as a recommendation for anemic

NCCN Updates Myelodysplastic Syndromes (MDS) Guidelines  -  Feb 26, 2007
Genetic Engineering News (press release),One of the major changes to the 2007 version of the guidelines was the addition of darbepoetin alfa (Aranesp(R), Amgen) as a recommendation for anemic

Amgen to Participate in Oncologic Drugs Advisory Committee in May  -  Mar 1, 2007
PharmaLive.com (press release),..."We look forward to providing an update to the ODAC on the Aranesp(R) (darbepoetin alfa) 103 trial involving cancer patients with anemia not due to

Amgen to participate in Oncologic Drugs Advisory Committee in May  -  Mar 1, 2007
SpiritIndia,...“We look forward to providing an update to the ODAC on the Aranesp® (darbepoetin alfa) 103 trial involving cancer patients with anemia not due to

Amgen to Participate in Oncologic Drugs Advisory Committee in May  -  Feb 28, 2007
Business Wire (press release),...“We look forward to providing an update to the ODAC on the Aranesp ® (darbepoetin alfa) 103 trial involving cancer patients with anemia not due to

Roche suspends phase II trial of its anemia drug  -  Feb 27, 2007
Earthtimes.org...one with another drug darbepoetin alfa -- and it believed this could be in part by deaths reported to be due to the progression of the underlying cancer

Roche suspends CERA Phase II oncology trial  -  Feb 25, 2007
eMaxHealth.com,...numerical imbalance in the number of deaths across the four arms of the study (three arms with CERA and one arm with darbepoetin alfa) driven in part by

Roche suspends enrollment for anemia drug trial  -  Feb 25, 2007
SpiritIndia,...a numerical imbalance in the number of de aths across the four arms of the study (three arms with CERA and one arm with darbepoetin alfa) driven in part

Off-Label Use of Aranesp Linked to Increased Mortality Risk  -  Feb 20, 2007
Medscape (subscription)The warning was based on data from a randomized phase 3 study of 989 patients showing that use of darbepoetin alfa injection (Aranesp, made by Amgen,

Aranesp Ineffective in Anemia Not Caused by Chemotherapy  -  Jan 29, 2007
Medscape (subscription)January 29, 2007 — A large, multicenter, randomized, placebo-controlled study has shown that darbepoetin alfa, marketed as Aranesp, failed in cancer

Amgen stock down amid concerns over Aranesp drug study  -  Feb 19, 2007
Pharma Times (subscription),...more than 522 patients, was designed to test whether Aranesp (darbepoetin alfa) enhanced radiation therapy in patients with head and neck cancer.

Anemia correction does little for short-term HF outcomes in small ...  -  Feb 16, 2007
TheHeart.Org,Somewhat strengthening the results was a significant correlation between expected hemoglobin increases from the active therapy, darbepoetin alfa (Aranesp,

Aranesp® to Be Used Only for Cancer Patients with Anemia Caused by ...  -  Jan 31, 2007
Cancer Consultants (press release),According to Amgen and the United States Food and Drug Administration (FDA), the agent Aranesp® (darbepoetin alfa) should only be used for its approved

Higher hemoglobin targets linked to increased mortality risk in ...  -  Feb 5, 2007
TheHeart.Org,They add that although treatment with ESAs, such as epoetin alfa and beta and darbepoetin alfa, has been linked to improved exercise capacity and cognition

Study Fails to Demonstrate Effectiveness of Aranesp® in Anemia of ...  -  Jan 31, 2007
Cancer Consultants (press release),Medications such as Procrit® (epoetin alfa) and Aranesp® (darbepoetin alfa) stimulate the body to produce more red blood cells, ultimately reducing anemia

Aranesp Alert  -  Jan 30, 2007
Facts and Comparisons,Amgen announced the results from a large, multicenter, randomized, placebo-controlled study that demonstrated a lack of effect of Aranesp (darbepoetin alfa)

Aranesp Data Eclipse Amgen's Fourth-Quarter Revenue Growth  -  Jan 26, 2007
BioWorld Online,Those figures, however, were overshadowed by results from a Phase III expanded-label study of Aranesp (darbepoetin alfa) to treat anemia in cancer patients

Fresenius Medical Care and Amgen Enter New Commercial ...  -  Feb 1, 2007
PharmaLive.com (press release),...leading renal therapy company, today announced that it has entered into a new agreement with Amgen Europe (Amgen) for Aranesp (darbepoetin alfa).

Amgen’s Anemia Drug Aranesp Carries Risk in Cancer Patients  -  Jan 29, 2007
Newsinferno.com,...drug maker Amgen warned of an elevated risk of fatalities associated with the use of their anemia drug, Aranesp (darbepoetin alfa), in cancer patients.

Amgen Warns of Mortality Risk for Off-Label Use of Aranesp  -  Jan 29, 2007
MedPage Today,29 -- For cancer patients with anemia not caused by chemotherapy, the off-label use of Aranesp (darbepoetin alfa) is ineffective and also boosts mortality,

HUDON GETS 10 YEARS & $100000 FINE  -  Jan 26, 2007
Harnesslink,While originally developed to treat people suffering from anemia associated with chronic renal failure, Aranesp (darbepoetin alfa) is classed as a potent

Treatment of Anemia in Chronic Kidney Disease  -  Dec 26, 2006
Medscape (subscription)Darbepoetin alfa, a second-generation erythropoiesis-stimulating agent, contains 2 amino acid substitutions, which provide the protein with greater

Roche Offers The FDA Additional Mircera Data  -  Dec 28, 2006
Medical News Today (press release),This included treating anaemia in previously untreated patients and maintaining haemoglobin (Hb) after conversion from epoetin alfa/beta or darbepoetin alfa

DENNIS MOFFAT SUSPENDED  -  Dec 22, 2006
Harnesslink,Erythropeietin/darbepoetin-alfa, which is commonly known as EPO, triggers the horse's body to produce more red blood cells and is thought to improve

Medicare reimbursement policy for erythropoietin in ESRD flawed  -  Jan 10, 2007
TheHeart.Org,Biotech) and darbepoetin alfa (Aranesp, Amgen). Among ESRD patients in the US treated with epoetin, 95% receive Epogen and the rest receive Aranesp.

Early Intervention with Aranesp® In Dose-dense Therapy Reduces ...  -  Dec 21, 2006
Cancer Consultants (press release),According to a study recently presented at the 2006 annual San Antonio Breast Cancer Symposium, early intervention with Aranesp® (darbepoetin alfa) allows

Horse racing officials applaud stiffer drug testing  -  Jan 3, 2007
Canada.com,...against Jerry ''Dennis'' Moffatt after his horse, Donegal Bill, tested positive for the drug erythropeietin/darbepoetin-alfa, commonly known as EPO.

ORC slaps harness trainer with 10-year ban  -  Dec 23, 2006
Calgary Sun,Ont., horseman has been issued a 10-year ban after blood samples on his pacer, Donegal Bill, showed the presence of erythropeietin/darbepoetin-alfa,

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