amgen inc (AMGN) Key Developments
Amgen Submits New Drug Application for Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)
Aug 25 15
Amgen announced the submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on hemodialysis. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone (PTH). Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD. The submission includes data from three Phase 3 studies, all of which met the primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet.
Amgen Opens New $300 Million Amgen Facility in Dun Laoghaire, Dublin
Aug 24 15
Amgen opened a new $300 million facility in Dun Laoghaire, Dublin. Work on the project, which was supported by the Department of Jobs through IDA Ireland, began in November 2011, creating over 500 construction jobs.
Amgen Inc. Presents at UBS Genomics 2.0 Summit, Aug-13-2015 10:00 AM
Aug 10 15
Amgen Inc. Presents at UBS Genomics 2.0 Summit, Aug-13-2015 10:00 AM. Venue: The St. Regis Deer Valley, Park City, Utah, United States.
Dr. Reddy's Laboratories Ltd. Announces Strategic Collaboration with Amgen in India
Aug 6 15
Dr. Reddy’s Laboratories Ltd. announced that it has entered into a strategic collaboration with Amgen to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. Under the terms of the collaboration, Dr. Reddy’s shall perform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India. The collaboration leverages the capabilities of both companies, combining three of Amgen’s innovative therapies with Dr. Reddy’s deep understanding of patient and physician needs in India.
Amgen Inc. Announces Appointment of Fred Hassan to Board of Directors
Jul 30 15
Amgen Inc. announced that on July 28, 2015, the Board of Directors of the Company appointed Fred Hassan as a director of the Company, effective immediately. Mr. Hassan is Partner and Managing Director at Warburg Pincus LLC since 2011. Mr. Hassan will serve as a member of the Audit Committee and the Compensation and Management Development Committee of the Board.