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- Amgen Announces Interim Results of Aranesp® "PREPARE" Study in Breast Cancer Patients
- THOUSAND OAKS, Calif. -- Amgen, Inc. (NASDAQ: AMGN) today announced that it had received interim results from the independent investigator-sponsored "PREPARE" study, an open-label, randomized, multicenter Phase 3 study of Aranesp([R]) darbepoetin alfa in 733 neoadjuvant breast cancer patients receiving dose-dense, dose-intense preoperative chemotherapy compared to a standard preoperative chemotherapy...
- Research articles 2007-11-30
- Amgen Receives Proposal for Amending EU Prescribing Information for Aranesp®
- THOUSAND OAKS, Calif. -- Amgen (NASDAQ:AMGN) today announced that the European Medicines Agency's EMEA Committee for Medicinal Products for Human Use CHMP has communicated to Marketing Authorization Holders MAHs of epoetins a proposal for amending prescribing information for Erythropoiesis Stimulating Agents ESAs in the European Union, including Aranesp([R]) darbepoetin alfa.
- Research articles 2007-09-27
- Amgen Submits Supplemental Biologics License Application for Aranesp Extended Dosing; Phase 3 Study Evaluated Aranesp Dosed Once Every Three Weeks in Patients with Chemotherapy-Induced Anemia
- THOUSAND OAKS, Calif. -- Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced the submission of a supplemental Biologics License Application sBLA to the U.S. Food and Drug Administration FDA for AranespR darbepoetin alfa. The sBLA is based on Phase 3 data that Amgen believes will demonstrate Aranesp administered...
- Research articles 2005-05-06
- FDA Approves Extended Dosing of Aranesp® to Treat Chemotherapy-Induced Anemia; Every-Three-Week Dosing Can Provide Added Convenience, Potentially Reducing Number of Clinic Visits and Injections for Anemia Treatment
- THOUSAND OAKS, Calif. -- Amgen (NASDAQ:AMGN), the world's largest biotechnology company, today announced the U.S. Food and Drug Administration FDA has approved every-three-week dosing of AranespR darbepoetin alfa for the treatment of chemotherapy-induced anemia low red blood cell count in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent...
- Research articles 2006-03-27
- Ventura County Star, Calif., Business Briefs Column.
- Ventura County Star, Calif. Knight Ridder/Tribune Business News Sep. 5--AMGEN DRUG OK'D FOR SALE IN BRITISH COLUMBIA: British Columbia regulators have given Amgen permission to sell its new extended-release drug Aranesp for treatment of anemia associated with chronic kidney disease. ...
- Research articles 2002-09-05
- Ventura County Star, Calif., Business Briefs Column.
- Ventura County Star, Calif. Knight Ridder/Tribune Business News Aug. 22--AMGEN STUDY CITED IN PRESTIGIOUS JOURNAL A two-year-old study used by Amgen Inc. to obtain regulatory approval for its new anemia drug Aranesp on Wednesday received renewed interest in a prestigious medical ...
- Research articles 2002-08-22
- EU Commission Approves Updated Prescribing Information for Aranesp®
- THOUSAND OAKS, Calif. -- Amgen (NASDAQ: AMGN) today announced that the European Commission reached its final decision to amend the prescribing information for Aranesp([R]) darbepoetin alfa based on the positive opinion from the European Committee for Medicinal Products for Human Use CHMP in January 2008. The CHMP granted positive opinions...
- Research articles 2008-03-05
- Amgen Receives Complete Response Letter for Extended Dosing of Aranesp® for Patients with Chronic Kidney Disease and Anemia
- THOUSAND OAKS, Calif. -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration FDA has issued a complete response letter, commonly referred to as an "approvable" letter, for Aranesp[R] darbepoetin alfa de novo once every-two-week and maintenance once-monthly dosing regimens for chronic kidney disease CKD patients with anemia...
- Research articles 2006-10-13
- Amgen Statement on Aranesp Manuscript in the Journal of Clinical Oncology
- THOUSAND OAKS, Calif. -- Amgen (NASDAQ:AMGN) issued the following statement on the publication of an Aranesp([R]) darbepoetin alfa manuscript in the January 28, 2008, online issue of the Journal of Clinical Oncology. Amgen anticipates this manuscript will be available in the March 1, 2008, print edition.
- Research articles 2008-01-29
- Amgen Reports Solid 2Q Results Despite Delay of Aranesp US Launch.(Brief Article)
- BIOTECH LEADER Amgen reported solid second quarter earnings, beating analysts estimates on sales of its top-selling anemia drug Epogen epoetin alfa and immunity-boosting drug Neupogen filgrastim. Key to the company s future growth is Aranesp (d BIOTECH LEADER Amgen reported solid second quarter earnings,...
- Research articles 2001-08-06
- Amgen's Epogen Successor Aranesp Gets FDA Approval.(Brief Article)
- IN A MAJOR boost to its drug franchise, Amgen has received US marketing authorization for Aranesp darbepoetin alfa, the successor to its top-selling anemia drug Epogen epoetin alfa. IN A MAJOR boost to its drug franchise, Amgen has received US marketing authorization...
- Research articles 2001-09-24
- Amgen Responds to Reports About Use and Safety of EPOGEN and Aranesp in CKD Anemia Therapy
- THOUSAND OAKS, Calif. -- Amgen (NASDAQ:AMGN), today posted to its corporate web site documents intended to clarify Amgen's position on the use of EPOGEN([R]) Epoetin alfa and Aranesp([R]) darbepoetin alfa and to correct what the company believes are misleading and inaccurate news reports regarding the use of its drugs. Amgen's...
- Research articles 2006-12-05
- Amgen posts solid first quarter from Neulasta and Aranesp sales. (Markets: Life Sciences).
- AMGEN INC. posted solid first quarter results on strong sales of second-generation drugs Neulasta pegfilgrastim and Aranesp darbepoetin alfa. Amgen projects earnings per share for 2003 of $1.80 to $1.90 versus its previous estimate of $1.70 to AMGEN INC. posted solid first quarter...
- Research articles 2003-04-28
- Active pharmaceutical ingredient watch. (Markets: Life Sciences).(various briefs)(Brief Article)
- AMGEN Inc. reports that the European Commission recommended approval of Aranesp darbepoetin alfa for treating anemia in adult cancer patients with non-hematological malignancies receiving chemotherapy. Amgen's Neulasta pegfilgrastim was also re AMGEN Inc. reports that the European Commission recommended approval of Aranesp (darbepoetin...
- Research articles 2002-06-10
Additional Resources
- Amgen Data to Be Presented at ASCO
- Wireless News05-31-2009Amgen Data to Be Presented at ASCOType: NewsAmgen announced it will present new data from the Company's oncology portfolio of approved and investigational cancer products at the 2009 American Society of Clinical Oncology ASCO Annual Meeting in Orlando, Fla. from May 29 to June 2. Data will be...
- Articles 2009-05-31
- New Findings Provide Additional Insights into the Management of Anaemia and Secondary Hyperparathyroidism in Chronic Kidney Disease Patients.
- MILAN, May 25 /PRNewswire/ -- Data presented from large-scale observational studies provide new insights into the day-to-day management of two major complications of CKD: anaemia and secondary hyperparathyroidism SHPT.(1), (2), (3), (4) - CKD...
- Articles 2009-05-25
- Amgen Data to Be Presented at ASCO
- Wireless News05-16-2009Amgen Data to Be Presented at ASCOType: NewsAmgen announced it will present new data from the Company's oncology portfolio of approved and investigational cancer products at the 2009 American Society of Clinical Oncology ASCO Annual Meeting in Orlando, Fla. from May 29 to June 2. Data will be...
- Articles 2009-05-16
- Amgen Highlights Data to Be Presented at ASCO
- New VectibixR Panitumumab Combination Chemotherapy Data New Data Reinforce Importance of Infection Prevention in Chemotherapy Patients Oncology Pipeline Continues to Advance With New Data in Multiple Tumor Types THOUSAND OAKS, Calif., May 15 /PRNewswire-FirstCall/ -- Amgen today announced it will present new...
- Articles 2009-05-15
- Product Shifts are Occurring in the Renal Anemia and Bone and Mineral Metabolism Markets According to the Most Recent TreatmentTrends®: US Nephrology Report from BioTrends Research Group
- EXTON, Pa., April 27 /PRNewswire/ -- BioTrends Research Group, Inc. released TreatmentTrendsR: 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...
- Articles 2009-04-28
- Amgen's anemia drug sales miss 4Q estimates
- Amgen Inc. Thousand Oaks CA, the world's largest biotechnology company, reported that fourth-quarter sales of its core products to treat anemia were lower than analysts expected. Net income climbed 15% to $961 million, or 91 cents a share, from $835 million, or 76 cents a share, a year earlier. Earnings,...
- Articles 2009-02-02
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