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...
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.
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...
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...
Epogen and Aranesp: A court date is set for next November in the copyright suit filed by drug maker Amgen Inc. that alleged Swiss drug maker and competitor Roche copied its anemia drugs Epogen and Aranesp to create a new drug, ... Epogen and...
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.
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...
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...
Thousand Oaks-based biomedical giant Amgen was dealt a blow last week in its bid to squash competitors for its anemia drugs, Epogen and Aranesp. Thousand Oaks-based biomedical giant Amgen was dealt a blow last week in its bid to squash competitors for its...
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,...
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...
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...
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...
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...
Reportlinker.com announces that a new market research report related to the Cardiovascular diseases industry is available in its catalogue. Blood Disorders Market Analysis and Forecasts Report to 2013 http://www.reportlinker.com/p090280/Blood-Disorders-Market-Analysis-and-Forecasts-Report-to-2013.html In 2007, blood diseases cost the US's economy $114bn. In 2004, a reported 232,000 deaths...
BIRMINGHAM, Ala., June 18 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals today announced that William P. Sheridan, MB BS, has been appointed Chief Medical Officer of BioCryst, effective July 1, 2008. Dr. Sheridan is a seasoned biotechnology professional, most recently serving as Vice President of North American...
AURORA, Colo. -- Vitro Diagnostics, Inc. (OTCBB: VODG), dba Vitro Biopharma announced the appointment of Erik Van Horn, BSCHE to its Board of Directors. Mr. Van Horn is presently employed as a Manufacturing Senior Specialist with Amgen, Inc. Mr. Van Horn is responsible for management of critical...
CHICAGO -- Zacks Equity Research highlights ConocoPhillips (NYSE: COP) as the Bull of the Day and General Motors (NYSE: GM) as the Bear of the Day. In addition, Zacks Equity Research provides analysis on Amgen, Inc. (Nasdaq: AMGN), Web.com (Nasdaq: WWWW) and Oxford Industries (NYSE: OXM). ...
EXTON, Pa., June 5 /PRNewswire/ -- BioTrends Research Group, Inc. is pleased to announce the release of TreatmentTrendsTM: European Nephrology Study II. The report is based on the results of an on-line survey completed by 203 clinical nephrologists in the UK, France, Germany, Italy, and Spain....
Drugs used widely to treat anemia in cancer patients may actually speed progression of the cancer in certain individuals, but researchers report they may found a way to determine who those individuals are. "We may have a test to predict whether a patient is susceptible to having their tumor...
Articles 2008-06-02
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