European Commission Approves Expanded Use Of Mimpara ® (Cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Children With End-Stage Renal Disease On Dialysis
THOUSAND OAKS, Calif., Aug. 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara® (cinacalcet) for the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end‑stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.
"Secondary HPT is a serious and complex condition, and there are currently limited treatment options available for pediatric patie...
Source: Amgen News Release - August 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Long-Term Analysis Of Phase 3 Head-To-Head Study Confirms KYPROLIS ® (Carfilzomib) Regimen Extends Overall Survival In Patients With Relapsed Multiple Myeloma
ENDEAVOR Study Long-Term Data Shows KYPROLIS and Dexamethasone Reduced the Risk of Death by 24 Percent Versus Velcade® (Bortezomib) and Dexamethasone
Patients Treated With the KYPROLIS-Based Regimen Survived 9.0 Months Longer Than Patients Receiving Velcade and Dexamethasone
Long-Term Follow-Up Demonstrated Consistent Safety Profile
THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive results from a post-hoc analysis requested by the U.S. Food and Drug Administration (FDA) of the Phase 3 head-to-head ENDEAVOR trial, which followed patients for at least three years af...
Source: Amgen News Release - August 30, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
FDA Accepts Amgen's Filing Of A Supplemental New Drug Application To Add Overall Survival Results To KYPROLIS ® (Carfilzomib) Label
FDA Sets PDUFA Target Action Date of April 30, 2018
THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that KYPROLIS® (carfilzomib) and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd ver...
Source: Amgen News Release - August 30, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
New Analysis Shows Repatha ® (Evolocumab) Reduces Cardiovascular Events In Patients With History Of Stroke
THOUSAND OAKS, Calif., Aug. 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a new analysis showed lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) reduced the risk of cardiovascular events in a sub-group of patients with a history of stroke from the Repatha cardiovascular outcomes study (FOURIER). No new safety concerns were identified in this cohort of more than 5,000 patients. Detailed results were presented today in a Late-Breaking Clinical Trials session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain.
"The clinical benefits o...
Source: Amgen News Release - August 29, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
New Virtual Histology Sub-Study Evaluates Impact Of Repatha ® (Evolocumab) On Coronary Artery Plaque Composition
Late-Breaking Clinical Trial Presented at ESC 2017
THOUSAND OAKS, Calif., Aug. 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from an exploratory virtual histology sub-study of the Repatha® (evolocumab) GLAGOV Phase 3 coronary intravascular ultrasound imaging trial that looked at coronary artery plaque composition. While virtual histology demonstrated an increase in dense calcium in coronary artery plaques in both the statin and Repatha arms, it did not detect a statistically significant difference between the two treatment groups. However, the observed directional trend in increased dense calc...
Source: Amgen News Release - August 29, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
New Repatha ® (evolocumab) Analysis Demonstrates Cardiovascular Outcomes Efficacy And Safety Of Achieving Very Low LDL-C Levels
Data Supports Lower LDL-C Levels for High-Risk Cardiovascular Patients
Simultaneously Presented at ESC 2017 and Published in The Lancet
THOUSAND OAKS, Calif., Aug. 28, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced a new analysis from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease. There was no evidence of a leveling off of effect and no new safety concerns ...
Source: Amgen News Release - August 28, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen Foundation Expands The Amgen Biotech Experience, Bringing Total Program Reach To 900,000 High School Students By 2020
Program to Expand to Australia, Canada, China, France, Germany, Hong Kong SAR, Italy, Netherlands, and Singapore
Recent Research Shows Students Gain Confidence, Interest in Science and Biotechnology After Participating in Program
THOUSAND OAKS, Calif., Aug. 24, 2017 /PRNewswire/ -- The Amgen Foundation today announced it will expand the Amgen Biotech Experience (ABE) to reach nearly 900,000 high school students by 2020. For nearly 30 years, ABE has empowered high school science teachers to implement real-world biotechnology labs in their classrooms to help their students better understand science and how it influenc...
Source: Amgen News Release - August 24, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Overall Survival Analysis From KYPROLIS ® (carfilzomib) Phase 3 Endeavor Trial Published In The Lancet Oncology
KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent Compared to Velcade® (bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
KYPROLIS is the First and Only Multiple Myeloma Therapy Proven to Extend Overall Survival in a Head-to-Head Comparison With a Current Standard of Care in the Relapsed Setting
THOUSAND OAKS, Calif., Aug. 23, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that results from an overall survival (OS) analysis of the Phase 3 head-to-head ENDEAVOR trial were published online first in The Lancet Oncology. Data showed that KYPROLIS® (carfilzomi...
Source: Amgen News Release - August 23, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
New Economic Analysis Based On Repatha ® (Evolocumab) Outcomes Data Published In JAMA Cardiology
Repatha Used in Patients at High-Risk For Cardiovascular Events is Cost-Effective at Net Prices at or Below $9,669
THOUSAND OAKS, Calif., Aug. 23, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from a new Repatha® (evolocumab) economic analysis published in the Journal of the American Medical Association (JAMA) Cardiology. The study identifies the clinical and economic consequences of treating a population of patients at high-risk of cardiovascular (CV) events and defines the cost-effectiveness of Repatha under various clinical scenarios. The analysis is based on the clinical outcomes from the Repa...
Source: Amgen News Release - August 23, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen To Present New Data From The Repatha ® (Evolocumab) Cardiovascular Outcomes Study At ESC Congress 2017
Analysis Evaluates the Effect of Repatha in More Than 5,000 Patients With a History of Stroke
THOUSAND OAKS, Calif., Aug. 21, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new data from the Repatha® (evolocumab) clinical trial program, including three late-breaking scientific sessions, will be presented at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain, Aug. 26-30, 2017. New data includes additional efficacy and safety analyses from the Repatha cardiovascular outcomes trial (FOURIER) and the Repatha coronary intravascular ultrasound imaging trial (GLAGOV).
"Data from t...
Source: Amgen News Release - August 21, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen And Humana Partner For Improved Health Outcomes And Efficiency
Partnership to Target Multiple Serious Diseases Using Real World Data Studies
THOUSAND OAKS, Calif. and LOUISVILLE, Ky., Aug. 17, 2017 /PRNewswire/ -- Two of the nation's leading health organizations, health and well-being company Humana Inc. (NYSE: HUM) and biotechnology company Amgen (NASDAQ:AMGN), have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana's 13 million members.
In the collaboration agreement between Amgen and Humana, six projects are currently underway or planned, with more expected...
Source: Amgen News Release - August 17, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Repatha ® (Evolocumab) Phase 3 Cognitive Function Study Results Published In The New England Journal Of Medicine
Study Showed Lowering LDL-C With Repatha Did Not Impair Cognition
Results From One of the Largest Cognitive Function Trials Support Safety Profile of Repatha
THOUSAND OAKS, Calif., Aug. 16, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the New England Journal of Medicine (NEJM) published results from the Repatha® (evolocumab) cognitive function trial (EBBINGHAUS), which was conducted in a subset of patients enrolled in the randomized, placebo-controlled Repatha cardiovascular outcomes study (FOURIER). The study demonstrated that Repatha was non-inferior to placebo, with no significant difference in...
Source: Amgen News Release - August 16, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen Submits Supplemental Biologics License Application For Prolia ® (denosumab) In Glucocorticoid-Induced Osteoporosis
THOUSAND OAKS, Calif., July 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
Osteoporosis can be caused by glucocorticoid medications, which are prescribed to treat inflammatory diseases. Within the first three months of beginning glucoco...
Source: Amgen News Release - July 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 980 To US Food And Drug Administration
Filing for ABP 980, a Biosimilar Candidate to Herceptin® (trastuzumab), Supported by Phase 3 Data in Patients With HER2-Positive Early Breast Cancer
THOUSAND OAKS, Calif., July 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.
"The submission of ABP 980 for FDA r...
Source: Amgen News Release - July 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen Announces 2017 Third Quarter Dividend
THOUSAND OAKS, Calif., July 28, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.15 per share dividend for the third quarter of 2017. The dividend will be paid on Sept. 8, 2017, to all stockholders of record as of the close of business on Aug. 17, 2017.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand ...
Source: Amgen News Release - July 28, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
