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Amgen Announces Webcast of 2017 Third Quarter Financial Results
THOUSAND OAKS, Calif., Oct. 20, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its third quarter financial results on Wednesday, Oct. 25, 2017, after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen's senior management team. Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors ...
Source: Amgen News Release - October 20, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Boston Children's Hospital Enter A Collaboration To Find New Genes And Drug Targets For Severe Pain Syndromes
CAMBRIDGE, Mass., Oct. 16, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Boston Children's Hospital today announced that they have entered into a neuroscience research collaboration aimed at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity. Amgen will leverage its industry-leading expertise in genetic target identification and validation and will have access to Boston Children's Hospital's Division of Pain Medicine to identify patients with abnormal pain conditions. Amgen and Boston Children's Hospital will collaborat...
Source: Amgen News Release - October 16, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Foundation Awards Khan Academy $3 Million To Support Development Of Free Comprehensive Biology Lessons
More Than One Million Students Access Biology Content Each Month THOUSAND OAKS, Calif. and MOUNTAIN VIEW, Calif., Oct. 12, 2017 /PRNewswire/ -- The Amgen Foundation today announced a three-year, $3 million grant to Khan Academy to develop comprehensive new biology lessons. The Amgen Foundation is the exclusive sponsor of Khan Academy's biology content. With the Amgen Foundation's support, Khan Academy will create new biology lessons for students and teachers worldwide. New videos, articles and practice exercises for ninth-grade biology through Advanced Placement Program® (AP®) b...
Source: Amgen News Release - October 12, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Accepts Supplemental Biologics License Application For Prolia ® (Denosumab) In Glucocorticoid-Induced Osteoporosis
Glucocorticoid-Induced Osteoporosis is the Most Common Form of Secondary Osteoporosis THOUSAND OAKS, Calif., Oct. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act ...
Source: Amgen News Release - October 9, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And LabCentral Open Nomination Process For Lab Residency
Opportunity for Life Sciences and Biotech Startups to Submit Proposal to Win Golden Ticket CAMBRIDGE, Mass., Oct. 6, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and LabCentral today announced that the nomination process to submit proposals to receive an Amgen-sponsored LabCentral Golden Ticket is open for interested life sciences and biotech startup companies. LabCentral is an innovative, shared laboratory space designed as a launchpad for premier high-impact life sciences and biotech startups. As one of LabCentral's platinum sponsors, Amgen can nominate up to two early-stage companies each year to take up residence in ...
Source: Amgen News Release - October 6, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

First Randomized Study To Evaluate IMLYGIC ® (Talimogene Laherparepvec), An Oncolytic Viral Therapy, In Combination With A Checkpoint Inhibitor Published In The Journal Of Clinical Oncology
Results Demonstrated a Doubling of Objective Response Rate Compared to Ipilimumab Alone in Unresectable Advanced Melanoma Responses Were Not Limited to Injected Lesions and Favored the Combination Arm Across Subsets of Disease THOUSAND OAKS, Calif., Oct. 5, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Journal of Clinical Oncology has published positive results from the IMLYGIC® (talimogene laherparepvec) Phase 2 '264 study. The study met its primary endpoint of objective response rate (ORR), demonstrating that IMLYGIC in combination with YERVOY® (ipilimumab) more than doubled ORR, define...
Source: Amgen News Release - October 5, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And CytomX Therapeutics Announce Strategic Collaboration In Immuno-Oncology
Companies to Jointly Develop T-Cell Engaging Bispecific Probody THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Oct. 3, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and CytomX Therapeutics, Inc., (NASDAQ:CTMX) today announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX Probody™ T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cell...
Source: Amgen News Release - October 3, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA ™
Amgen to Begin Launching Biosimilar Adalimumab in Europe in 2018 THOUSAND OAKS, Calif., Sept. 28, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it has reached a global settlement with AbbVie to resolve all pending litigation regarding AMGEVITA™/AMJEVITA™, a biosimilar to AbbVie's Humira® (adalimumab). Under terms of the agreement, AbbVie will grant patent licenses for the use and sale of AMGEVITA/AMJEVITA worldwide, on a country-by-country basis, and the companies have agreed to dismiss all pending litigation. Amgen expects to launch AMGEVITA in Europe on Oct. 16, 2018, a...
Source: Amgen News Release - September 28, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Simcere Announce Strategic Collaboration To Co-Develop And Commercialize Biosimilars In China
THOUSAND OAKS, Calif. and NANJING, China, Sept. 26, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote...
Source: Amgen News Release - September 26, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Provides Update On Hurricane Maria
No Interruption to Patient Supply Anticipated Company Reaffirms 2017 Financial Guidance THOUSAND OAKS, Calif., Sept. 25, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today provided an update on Hurricane Maria's impact on the Company's manufacturing facilities in Puerto Rico. The safety of the more than 2,000 Amgen colleagues and their families on the island remains a top priority for Amgen, and outreach to impacted staff is ongoing.  "The Company's preliminary assessment is that the critical manufacturing areas in our facility in Juncos, Puerto Rico, have not been significantly impacted by ...
Source: Amgen News Release - September 25, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Foundation Pledges Up To $5 Million To Hurricane Maria Relief Efforts
Amgen Foundation Pledges $3 Million for Urgent Relief Efforts Amgen Foundation Also Commits up to an Additional $2 Million for Longer-Term Rebuilding Efforts Amgen Staff Disaster Relief Fund Deployed to Assist Puerto Rico-Based Staff THOUSAND OAKS, Calif., Sept. 22, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Amgen Foundation has pledged $3 million to support urgent Hurricane Maria relief efforts in Puerto Rico. The Foundation also has committed up to an additional $2 million for longer-term rebuilding efforts.  Amgen is also activating its Staff Disaster Relief Fund to aid Amg...
Source: Amgen News Release - September 22, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

New FOURIER Analysis Shows Repatha ® (Evolocumab) Reduces Cardiovascular Events In Patients With Diabetes
Data Supports Safety and Efficacy of Repatha in Patients With Diabetes Simultaneously Presented at EASD 2017 and Published in The Lancet Diabetes & Endocrinology THOUSAND OAKS, Calif., Sept. 15, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a new analysis of the cardiovascular outcomes study (FOURIER) demonstrated that lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) significantly and consistently reduced cardiovascular events in patients with and without diabetes at baseline. The analysis showed that diabetes was independently associated wi...
Source: Amgen News Release - September 15, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Amgen And Allergan's MVASI ™ (bevacizumab-awwb) For The Treatment Of Five Types Of Cancer
Approval Based on Totality of Evidence From Global Development Program Showing MVASI™ is Highly Similar to Avastin® (bevacizumab) First Ever Biosimilar to Fight Cancer Approved by FDA THOUSAND OAKS, Calif., Sept. 14, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. MVASI i...
Source: Amgen News Release - September 14, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The Bank of America Merrill Lynch Global Healthcare Conference
THOUSAND OAKS, Calif., Sept. 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference at 9:45 a.m. GMT on Thursday, Sept. 14, 2017, in London. David W. Meline, executive vice president and chief financial officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event. About Amgen Amgen is committed to unlocking the potential of bio...
Source: Amgen News Release - September 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

EVENITY ™ (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine
EVENITY Followed by Alendronate Reduced the Incidence of New Vertebral, Clinical, Non-Vertebral and Hip Fractures Compared to Alendronate Alone Additional Details on Observed Cardiovascular Safety Signal Provided THOUSAND OAKS, Calif. and BRUSSELS, Sept. 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced detailed results from the Phase 3 ARCH study showing that 12 months of EVENITY™* (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fract...
Source: Amgen News Release - September 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Allergan Present Phase 3 Data On Biosimilar Trastuzumab Candidate ABP 980 At The European Society For Medical Oncology 2017 Congress
Study Between ABP 980 and Trastuzumab in Patients With HER2-Positive Early Breast Cancer Adds to the Totality of Evidence of Biosimilarity THOUSAND OAKS, Calif. and DUBLIN, Sept. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced data from a Phase 3 study evaluating the efficacy and safety of ABP 980, a Herceptin® (trastuzumab) biosimilar, compared with the originator product in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Results from the neoadjuvant efficacy phase of the study, including pathologic complete response ass...
Source: Amgen News Release - September 9, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Highlights The Latest EVENITY ™ (Romosozumab) And Prolia® (Denosumab) Research At The American Society For Bone And Mineral Research Annual Meeting
First Presentation of Detailed EVENITY ARCH Study Results and FRAME Extension Final Analysis 10-Year Data From Long-Term Prolia FREEDOM Study THOUSAND OAKS, Calif., Sept. 8, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that 19 scientific abstracts will highlight the latest scientific research on EVENITY™* (romosozumab) and Prolia® (denosumab) at this year's Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Denver from Sept. 8-11, 2017. "The data being presented at ASBMR underscore our steadfast focus for more than a decade to advance scientific unders...
Source: Amgen News Release - September 8, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

New Data Demonstrate Aimovig ™ (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies
Aimovig Reduced Monthly Migraine Days for Patients With Chronic Migraine and Prior Treatment Failure, a Population With Significant Unmet Need Results From New Dedicated Cardiovascular Study Support Overall Safety Profile Observed in Aimovig Clinical Study Program Aimovig is the Only Investigational Biologic Product Specifically Designed to Prevent Migraine by Blocking the CGRP Receptor, Which is Associated With Migraine Activation THOUSAND OAKS, Calif., Sept. 7, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new data in patients with high unmet need, providing further evidence of the efficacy of A...
Source: Amgen News Release - September 7, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The Morgan Stanley Global Healthcare Conference
THOUSAND OAKS, Calif., Sept. 7, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley Global Healthcare Conference at 9:10 a.m. ET on Tuesday, Sept. 12, 2017, in New York City. Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering ...
Source: Amgen News Release - September 7, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Tezepelumab Significantly Reduced Asthma Exacerbations For A Broad Population Of Patients With Severe Uncontrolled Asthma
Novel Investigational Drug is Designed to Block Thymic Stromal Lymphopoietin (TSLP) - An Upstream Driver of Inflammation in Asthma Results Published Today in New England Journal of Medicine and to be Presented at European Respiratory Society (ERS) Congress Next Week THOUSAND OAKS, Calif., Sept. 6, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca (NYSE:AZN) today announced results from the PATHWAY Phase 2b trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a novel anti-thymic stromal...
Source: Amgen News Release - September 6, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

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...
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 y...
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 mon...
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...
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 den...
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 co...
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® (...
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 t...
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). &...
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 ...
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 differ...
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 ...
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 AB...
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

FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha ® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events
FDA Priority Review Status Underscores Need to Reduce Heart Attacks and Strokes THOUSAND OAKS, Calif., July 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER). The FDA has set a Prescription Drug User...
Source: Amgen News Release - July 27, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Reports Second Quarter 2017 Financial Results
THOUSAND OAKS, Calif., July 25, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2017. Key results include: Total revenues increased 2 percent versus the second quarter of 2016 to $5.8 billion. Product sales grew 2 percent driven by Prolia® (denosumab), Repatha® (evolocumab) and KYPROLIS® (carfilzomib). GAAP earnings per share (EPS) increased 18 percent to $2.91 driven by higher operating margins. GAAP operating income increased 13 percent to $2.7 billion and GAAP operating margin increased 4.9 percentage points to 48.4 percent. N...
Source: Amgen News Release - July 25, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Accepts Biologics License Application For Aimovig ™ (erenumab)
Aimovig is an Investigative Migraine-Specific Preventive Therapy Designed for Patients With High Unmet Need Migraine is Associated With Pain, Disability and Nearly $25 Billion in Annual U.S. Healthcare Costs[1],[2] THOUSAND OAKS, Calif., July 20, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovig™ (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only mono...
Source: Amgen News Release - July 20, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Webcast of 2017 Second Quarter Financial Results
THOUSAND OAKS, Calif., July 20, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its second quarter financial results on Tuesday, July 25, 2017, after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen's senior management team. Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and th...
Source: Amgen News Release - July 20, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Array BioPharma Announce Preclinical License And Collaboration Agreement In Inflammation
Array to Advance Preclinical Program for Autoimmune Disorders Amgen Responsible for Clinical Development and Worldwide Commercialization THOUSAND OAKS, Calif. and BOULDER, Colo., July 18, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Array BioPharma (NASDAQ:ARRY) today announced a collaboration agreement for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered through Array's proprietary platform that leverages Array's expertise in chemistry and early lead development.  "We are pleased to enter this collaboration with Array tha...
Source: Amgen News Release - July 18, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And UCB Provide Update On Regulatory Status Of EVENITY ™ (romosozumab) In The US
THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal Phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. With the availability of data from the Phase 3 active-comparator ARCH study, the Agency has asked that the efficacy and safet...
Source: Amgen News Release - July 16, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival Data In KYPROLIS ® (Carfilzomib) Label
Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent and Increased Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients THOUSAND OAKS, Calif., July 14, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in the product information fo...
Source: Amgen News Release - July 14, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Allergan To Discuss Data Supporting Biologics License Application For ABP 215, A Biosimilar Candidate To Avastin ® (bevacizumab)
First Amgen and Allergan Oncology Biosimilar Candidate to be Reviewed by U.S. FDA Advisory Committee THOUSAND OAKS, Calif., July 13, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced that the Companies will discuss data supporting the ABP 215 Biologics License Application (BLA) with the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA). ABP 215 is a biosimilar candidate to Avastin® (bevacizumab) and is the first bevacizumab biosimilar candidate to be considered by the FDA. "Amgen has worked diligently to apply our more tha...
Source: Amgen News Release - July 13, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Second Phase 3 Study Shows KYPROLIS ® (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma
KYPROLIS, Lenalidomide and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Lenalidomide and Dexamethasone Patients Treated With the KYPROLIS-Based Regimen Survived 7.9 Months Longer Than Patients on Lenalidomide and Dexamethasone KYPROLIS-Based Regimens Are the First and Only to Demonstrate Improved Overall Survival Versus Today's Standards of Care in Two Phase 3 Studies in Relapsed Multiple Myeloma THOUSAND OAKS, Calif., July 12, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive results from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint ...
Source: Amgen News Release - July 12, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Grants Full Approval for BLINCYTO ® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
BLINCYTO is the First-and-Only Bispecific T Cell Engager (BiTE®) Immunotherapy to Demonstrate Superior Overall Survival Versus Standard of Care Chemotherapy Data From the Phase 3 TOWER Study Support Conversion From Accelerated to Full Approval Indication Expansion Underscores Need for Effective Treatment Options THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 ...
Source: Amgen News Release - July 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And QB3@953 Announce Winners Of The Amgen Golden Ticket
Two Diagnostic Companies Will Receive Lab Space and Other Benefits at San Francisco Life Sciences Incubator SAN FRANCISCO, July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and QB3@953 today announced that Darmiyan and Enable Biosciences have won the Amgen Golden Ticket at QB3@953. Each company receives one year of lab space at the QB3@953 life sciences incubator, additional facility benefits and connections to Amgen's scientific and business leaders to help advance their scientific programs. The Amgen Golden Ticket program was launched by Amgen in 2015 to assist early-stage life sciences companies in their...
Source: Amgen News Release - July 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Vectibix ® (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer
Vectibix Demonstrated an Improvement in Overall Survival in Patients With Wild-Type RAS Metastatic Colorectal Cancer Predictive Biomarkers Allow Physicians to More Accurately Identify Treatments to Potentially Optimize Cancer Care Approved Companion Diagnostic Tool Strengthens Precision Medicine Approach THOUSAND OAKS, Calif., June 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NR...
Source: Amgen News Release - June 29, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives Positive CHMP Opinion To Expand Use Of Mimpara ® (cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Certain Children With End-Stage Renal Disease On Dialysis
THOUSAND OAKS, Calif., June 23, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara® (cinacalcet). Approval was recommended 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. &quo...
Source: Amgen News Release - June 23, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present New Data At 22nd Congress of the European Hematology Association
Oral Presentation of Phase 3 Data Shows KYPROLIS® (Carfilzomib) and Dexamethasone Improved Median Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed Multiple Myeloma New Subset Analysis Demonstrates BLINCYTO® (Blinatumomab) More Than Doubled Median Overall Survival Versus Standard of Care Chemotherapy in Adult Patients With Relapsed/Refractory Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in First Salvage Oral Presentation of New Data From Head-to-Head Phase 3 Study of XGEVA® (Denosumab) Versus Zoledronic Acid in Time to First On-Study Skeletal...
Source: Amgen News Release - June 21, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA ® (denosumab) To Include Multiple Myeloma Patients
FDA Sets PDUFA Target Action Date of Feb. 3, 2018 THOUSAND OAKS, Calif., June 19, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Feb. 3, 2018. "Multiple mye...
Source: Amgen News Release - June 19, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news