Recent news on Darbepoetin

Attenuation of Inflammation and Apoptosis by Pre- and ...  -  25 May 2007
Am J Pathology (subscription)Animals were either pretreated (24 hours before Gal-LPS exposure) or posttreated (30 minutes after Gal-LPS exposure) with darbepoetin- (DPO, 10 µg/kg iv).

MIRCERA Receives Positive Opinion in Europe for the Treatment of ...  -  25 May 2007
campus med,MIRCERA is the only drug to have compared itself in its registration program to three ESAs: epoetin alfa, beta and darbepoetin alfa.

CHMP backs Roche's Mircera  -  25 May 2007
Pharma Times (subscription),The FDAs letter came in the wake of an oncology advisory committee recommendation to further strengthening the warning labels on Aranesp (darbepoetin alfa),

FDA Panel warns anemia drug dangerous for cancer patients  -  May 14, 2007
News-Medical.net,The drugs which are known generically as darbepoetin and epoetin, are thought to be used by almost a half-million cancer patients a year in the United

Aranesp® and Epoetin Alfa Do Not Increase Blood Clots in Ovarian ...  -  May 2, 2007
Cancer Consultants (press release),Researchers from the University of North Carolina have reported that use of Aranesp® (darbepoetin alfa) or epoetin alfa (Procrit® or Epogen®) does not

Kirin's NESP Long-Acting Erythropoiesis Stimulating Agent ...  -  Apr 25, 2007
PharmaLive.com (press release),...and marketing approval for its long-acting erythropoiesis stimulating agent Darbepoetin Alfa, brand name NESP(R) Injection Syringe, on April 18, 2007.

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 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).

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.

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

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,

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,

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

Aranesp® Improves Hemoglobin Levels in Lung Cancer Patients  -  Apr 27, 2007
Cancer Consultants (press release),According to results from a Phase III trial, the use of Aranesp® (darbepoetin alfa) in patients with small cell lung cancer (SCLC) being treated with

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

Advisers urge restrictions on anemia drugs  -  May 12, 2007
Inland Valley Daily Bulletin,The drugs, known generically as darbepoetin and epoetin, were approved to reduce the need for blood transfusions in patients with anemia from chemotherapy.

FDA panel warns of anemia drug risks  -  May 11, 2007
Science Daily (press release)The New York Times said the drugs, known generically as darbepoetin and epoetin, are used by about a half-million US cancer patients a year.

Amgen and J&J hurt by FDA panel over anaemia drugs  -  May 11, 2007
Pharma Times (subscription),...voted 15-2 in favour of having further marketing authorisation of Amgen's erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa) and Epogen

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

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).

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 Associated With Increased Mortality in Cancer Patients ...  -  Apr 19, 2007
DG NewsCompared with placebo, patients treated with darbepoetin required fewer -- although not significantly fewer -- transfusions, but they also had a 23%

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

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

AACR: No Benefit for Darbepoetin Alfa (Aranesp) in Cancer-Caused ...  -  Apr 17, 2007
MedPage Today,Compared with 432 placebo patients, 419 patients treated with darbepoetin had a significant decrease in the need for transfusion, but there was a 23%

Amgen's (AMGN) Aranesp "145 Study'' Shows No Difference in ...  -  Apr 19, 2007
StreetInsider.com (subscription),...(darbepoetin alfa) in 600 previously untreated patients with extensive-stage small-cell lung cancer (SCLC) receiving platinum-containing chemotherapy.

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's First Quarter 2007 Revenue Increased 15 Percent to $3.7 ...  -  Apr 23, 2007
Genetic Engineering News (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.

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.

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 and J&J Funnel Tax Dollars Through Kidney and Cancer Patients  -  Apr 17, 2007
Lawyers and Settlements,In 2005, the drugs darbepoetin and epoetin, commonly used by patients who must undergo dialysis, accounted for almost 20% of the $13 billion spent on the

Lawmakers Go After Amgen and J&J Over Off-Label Sales of Anemia Drugs  -  Apr 22, 2007
Lawyers and Settlements,The drugs at issue include Aranesp, the brand name for darbepoetin, and Epogen and Procrit, the brand names for epoetin. Amgen manufactures all three drugs,

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").

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,

For-profit Dialysis Centres May Be Over-Treating Anemia  -  Apr 18, 2007
Medical News Today,The FDA has recently issued warnings for epoetin and another similar drug darbepoetin which is used to treat cancer patients with anemia.

Dialysis facility type may affect epoetin therapy  -  Apr 17, 2007
Scientific AmericanUS Food and Drug Administration advisory warning that epoetin and darbepoetin result in a 'an increased number of deaths and of non-fatal heart attacks,

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

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�).

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.

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.

Data Analyses Outline Efficacy and Safety of MIRCERA(TM) for the ...  -  Apr 12, 2007
PR Newswire (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.

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.

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

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,

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® 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®).

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

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

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,

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 )

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

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

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.

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.

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

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,

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,Moreover, the FDA said that there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin

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).

EPO From Human Cells Can Be Traced in Doping Tests, WADA Says  -  Mar 21, 2007
BloombergJohann Muehlegg and Larissa Lazutina gave back their Olympic gold medals at the 2002 Winter Games after testing positive for EPO drug darbepoetin.

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®).

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).

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).

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

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

Amgen Announces Update To US Prescribing Information for Aranesp(R ...  -  Mar 10, 2007
FinanzNachrichten.de,...information for the class of drugs known as Erythropoiesis-stimulating Agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (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,

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 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 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 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

Amgen Announces Update To US Prescribing Information for Aranesp ...  -  Mar 9, 2007
PharmaLive.com (press release),...for the class of drugs known as Erythropoiesis-stimulating Agents (ESAs), including Aranesp(R) (darbepoetin alfa) and EPOGEN(R) (Epoetin alfa).

FDA Updates Safety for Anemia Erythropoiesis-Stimulating Drugs  -  Mar 9, 2007
Playfuls.com,The US Food and Drug Administration released today, March 9, a statement announcing the strenghtening of safety-related information in the drugs darbepoetin

Great Scott!  -  Mar 5, 2007
Alberta Daily Herald Tribune (subscription),...skiing after two Russians were disqualified for using the drug darbepoetin, has been one of the loudest voices for cleaning up her own sport.

Unbeaten Ward to fight as part of San Jose card  -  Mar 1, 2007
Inside Bay Area,The out-of-competition testing began in mid-February, with a particular focus on two drugs — epoetin and darbepoetin. In humans, the drugs treat anemia,

Milestones in Don Catlin's Career  -  Feb 27, 2007
USA Today2002 — Catlin uses the French EPO test, and it detects the new blood enhancer darbepoetin. Three cross country skiers are caught using it at the 2002 Salt

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 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).

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

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