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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
- 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
- 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
- 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
- Amgen, Aranesp, and anemia patients get the bad news
- News items 2009-11-02
Additional Resources
- Amgen Sued By 15 States Over Aranesp Kickbacks
- The lawsuit charges Amgen - along with a specialty group purchasing organization known as International Nephrology Network and the ASD Healthcare wholesaler - with offering kickbacks to medical providers to increase sales of its Aranesp anemia drug, Aranesp. The multi-state suit, by the way, joins a whistleblower lawsuit filed in...
- News items 2009-10-30
- Aranesp studies show potential in anemia teatment paradigms.(Brief Article)
- Clinical data from four Aranesp darbepoetin alfa studies presented at the 38th annual meeting of the American Society of Clinical Oncology ASCO suggest new potential dosing approaches for treating anemia in patients with cancer. The loading dose paradigm study of Aranesp was shown to improve anemia...
- Research articles 2002-05-01
- Aranesp Suit: What Did Amgen CEO Sharer Know (and Did He Read It in His Company's PowerPoint Slides)?
- Amgen executives detailed their alleged Aranesp "overfill" kickback scheme in a set of PowerPoint slides and Excel spreadsheets, according to a lawsuit filed by the New York State Attorney General. The suit also describes an email in which colleagues of Amgen CEO Kevin Sharer asked for information on how Amgen...
- Blog posts 2009-11-02
- Amgen offer update on Aranesp for anemic patients and Nanogen issued patent for method of monitoring PCR using fluorescent energy transfer.
- M2 PRESSWIRE-7 July 2005-US Financial Network: Amgen offer update on Aranesp for anemic patients and Nanogen issued patent for method of monitoring PCR using fluorescent energy transferC1994-2005 M2 COMMUNICATIONS LTD RDATE:07072005 City of Industry, CA - Biotechnology industry news provided by...
- Research articles 2005-07-07
- Study cites concerns over Amgen drugs » Ventura County Star
- A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis. The study is the largest...
- News items 2009-10-31
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