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Amgen to terminate participation in co-development and commercialisation of brodalumab
26 May 2015 | By Victoria White
Amgen has announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab...
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Amgen receives positive CHMP opinion for use of Repatha for the treatment of high cholesterol
22 May 2015 | By Victoria White
The CHMP has adopted a positive opinion for the marketing authorisation of Amgen’s Repatha for use in certain patients with high cholesterol...
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Amgen presents positive first Phase 2 data for AMG 334 in the prevention of episodic migraine
18 May 2015 | By Victoria White
Amgen has announced the first results from its global Phase 2 study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine...
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FDA to review Amgen’s Repatha as a treatment for high cholesterol
30 April 2015 | By Victoria White
The FDA will review data supporting Amgen’s Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol...
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FDA grants Amgen priority review for Kyprolis for the treatment of relapsed multiple myeloma
31 March 2015 | By Victoria White
Amgen has announced that the FDA has accepted the sNDA of Kyprolis for the treatment of patients with relapsed multiple myeloma...
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Phase 3 head-to-head ENDEAVOR study demonstrates superiority of Kyprolis® (carfilzomib) over Velcade® (bortezomib) in patients with relapsed multiple myeloma
2 March 2015 | By Amgen
Study met primary endpoint of progression-free survival patients receiving Kyprolis lived twice as long without disease progression...
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Amgen receives positive CHMP opinion for use of Vectibix® (panitumumab) as first-line treatment for advanced colorectal cancer
2 March 2015 | By Amgen
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC)...
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Amgen presents long-term data showing efficacy and safety of investigational cholesterol-lowering medication evolocumab across lipid And LDL-C levels
Amgen (NASDAQ:AMGN) has announced new data from three separate analyses of Phase 2 and 3 studies evaluating evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication.
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RMM: In-Depth Focus 2014
Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable...
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Amgen announces appointment of R. Sanders Williams to Board of Directors
21 October 2014 | By Amgen
Amgen announced the appointment of R. Sanders Williams, M.D., president of Gladstone Institutes and Gladstone's Robert W. and Linda L. Mahley Distinguished Professor...
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Amgen submits Marketing Authorization Application for talimogene laherparepvec to the European Medicines Agency
3 September 2014 | By Amgen
First Marketing Authorization Application for an oncolytic immunotherapy in the European Union...
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Amgen announces positive top-line results from Phase 3 YUKAWA-2 trial of evolocumab
28 August 2014 | By Amgen
...in combination with statins in Japanese patients with high cardiovascular risk and high cholesterol.
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Amgen names Elliott M. Levy, M.D., Senior Vice President, Global Development
20 August 2014 | By Amgen
Amgen announced that Elliott M. Levy, M.D., has been named senior vice president, Global Development, effective Sept. 8, 2014...
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Amgen announces positive top-line results from second Phase 3 study of AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving hemodialysis
19 August 2014 | By Amgen
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, receiving hemodialysis, met its primary and all secondary endpoints...
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Amgen announces top-line results from Phase 3 focus trial of kyprolis® in patients with relapsed and advanced refractory multiple myeloma
15 August 2014 | By Amgen
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., announced that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival...
