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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

Amgen Presents Erenumab Data At The 59th Annual Scientific Meeting of the American Headache Society
Data From Broad Clinical Program Show Investigational Erenumab is Effective at Preventing Migraine in Patients Experiencing Four or More Migraine Days a Month THOUSAND OAKS, Calif., June 8, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will present 19 scientific abstracts at the 59th Annual Scientific Meeting of the American Headache Society (AHS) held June 8-11 in Boston. These include a new analysis from a pivotal Phase 2 study highlighting the efficacy of erenumab in patients with 15 or more headache days a month (chronic migraine) and a recent history of acute migraine medication overuse. A...
Source: Amgen News Release - June 8, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The Goldman Sachs 38th Annual Global Healthcare Conference
THOUSAND OAKS, Calif., June 8, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Goldman Sachs 38th Annual Global Healthcare Conference at 2:40 p.m. PT on Tuesday, June 13, 2017, in Rancho Palos Verdes, Calif. Sean E. Harper, M.D., executive vice president of Research and Development 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...
Source: Amgen News Release - June 8, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Allergan Announce FDA Advisory Committee Meeting To Review ABP 215, A Biosimilar Candidate To Bevacizumab
THOUSAND OAKS, Calif., June 7, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE: AGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Biologics License Application (BLA) for ABP 215, a biosimilar candidate to Avastin® (bevacizumab), on July 13, 2017. "Amgen has a long and proud heritage in oncology, and we are committed to providing physicians and patients a range of high quality therapeutic options," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "...
Source: Amgen News Release - June 7, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Submits Regulatory Applications For Repatha ® (evolocumab) Cardiovascular Outcomes Data In US And Europe
Applications Based on Data From Repatha Cardiovascular Outcomes Study Showing an Additional Reduction in Heart Attacks, Strokes and Coronary Revascularizations on Top of Optimized Statin Therapy THOUSAND OAKS, Calif., June 5, 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) and a variation to the marketing authorization to the European Medicines Agency (EMA) for Repatha® (evolocumab), a PCSK9 inhibitor. The regulatory submissions are based on the 27,564-pat...
Source: Amgen News Release - June 5, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Presents New Data From Phase 3 XGEVA ® (Denosumab) Study In Patients With Multiple Myeloma At ASCO 2017
Analysis Demonstrated XGEVA had a Significantly Lower Rate of Renal Adverse Events Compared to Zoledronic Acid Data Selected for Best of ASCO® Educational Program THOUSAND OAKS, Calif., June 4, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the XGEVA® (denosumab) Phase 3 '482 study, the largest international multiple myeloma trial ever conducted. The study met its primary endpoint, demonstrating XGEVA is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85, 1.14; p=0.01). The ...
Source: Amgen News Release - June 4, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Presents New Phase 2 Data On IMLYGIC ® (Talimogene Laherparepvec) Investigational Combination At ASCO 2017
First Randomized Study to Evaluate the Combination of IMLYGIC, an Oncolytic Viral Therapy, With a Checkpoint Inhibitor Data Demonstrate IMLYGIC in Combination With YERVOY® (Ipilimumab) Doubled Objective Response Rate in Unresectable Advanced Melanoma Responses Not Limited to Injected Lesions; 50 Percent or Higher Reduction in Visceral Lesion Size Occurred More Frequently in Patients in the Combination Arm THOUSAND OAKS, Calif., June 3, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the Phase 2 '264 study that demonstrated IMLYGIC® (talimogene laherparepvec) in combination with ...
Source: Amgen News Release - June 3, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Showcases A Legacy Of Science, Innovation And Collaboration In Cambridge
Massachusetts Governor Charles Baker and U.S. Senator Edward Markey Join Members of the Life Sciences Community at Newly Expanded Facility in Kendall Square CAMBRIDGE, Mass., June 2, 2017 /PRNewswire/ -- When Amgen (NASDAQ:AMGN) purchased a vacant parcel of land in the heart of Kendall Square in Cambridge, Mass. 25 years ago, the area was far from the thriving biotechnology hub it has since become. In 2001, Amgen, a biotechnology pioneer, completed construction of an eight-story, 297,000-square-foot facility on the site. Now one of the world's leading independent biotechnology companies, Amgen has expanded its pr...
Source: Amgen News Release - June 2, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And UCB Announce Top-Line Phase 3 Data From Active-Comparator Study Of EVENITY ™ (Romosozumab) In Postmenopausal Women With Osteoporosis
ARCH Study Met Primary and Key Secondary Endpoints by Reducing the Incidence of New Vertebral, Clinical and Non-Vertebral Fractures Imbalance in Cardiovascular Events Observed as New Safety Signal THOUSAND OAKS, Calif. and BRUSSELS, May 21, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the EVENITY™* (romosozumab) ARCH study met both primary endpoints and the key secondary endpoint. At the primary analysis, treatment with EVENITY for 12 months followed by alendronate significantly reduced the incidence of new vertebral fractures through 24 months, clinical f...
Source: Amgen News Release - May 21, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Repatha ® (Evolocumab) Reduced Cardiovascular Events In Patients With Baseline LDL-C Levels Below Current Targets
New Analysis From Cardiovascular Outcomes Trial Shows Addition of Repatha in Patients Considered at Goal Further Reduces Cardiovascular Event Risk Separate Analysis Demonstrates Consistent Cardiovascular Risk Reduction in Patients Even on Maximum-Intensity Statin Therapy THOUSAND OAKS, Calif., May 20, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the Repatha® (evolocumab) cardiovascular outcomes trial (FOURIER), which showed that Repatha consistently and safely reduced cardiovascular events in patients with established cardiovascular disease regardless of baseline low-density lipopr...
Source: Amgen News Release - May 20, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Voting Results of Annual Meeting of Stockholders
THOUSAND OAKS, Calif., May 19, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced voting results from the Company's Annual Meeting of Stockholders, held in Westlake Village, Calif. Approximately 90 percent of outstanding shares were represented at the meeting. The director nominees David Baltimore, Robert A. Bradway, François de Carbonnel, Robert A. Eckert, Greg C. Garland, Fred Hassan, Rebecca M. Henderson, Frank C. Herringer, Charles M. Holley Jr., Tyler Jacks, Ellen J. Kullman, Ronald D. Sugar and R. Sanders Williams were each re-elected to Amgen's Board of Directors. Each director received at...
Source: Amgen News Release - May 19, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Submits Biologics License Application To The FDA For Erenumab
Erenumab is an Investigative Treatment Specifically Designed to Prevent Migraine Only Molecule in Late-Stage Development to Directly Target the Calcitonin Gene-Related Peptide Receptor Amgen and Novartis to Co-Commercialize Erenumab in the U.S. THOUSAND OAKS, Calif., May 18, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for erenumab to prevent migraine. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor. This BLA includes data from pivo...
Source: Amgen News Release - May 18, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Highlights Data To Be Presented At ASCO 2017 Across Oncology Portfolio
Oral Presentation of New Analysis on Limited Renal Toxicity Associated With XGEVA® (denosumab) Compared With Zoledronic Acid in Treatment of Myeloma Bone Disease XGEVA Study in Patients With Myeloma Bone Disease Also Selected for Best of ASCO® First Randomized Study to Evaluate the Combination of IMLYGIC® (talimogene laherparepvec), an Oncolytic Viral Immunotherapy, With a Checkpoint Inhibitor to be Presented THOUSAND OAKS, Calif., May 17, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new clinical data and analyses from across its oncology portfolio will be presented at the 53rd An...
Source: Amgen News Release - May 17, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The Bank Of America Merrill Lynch 2017 Health Care Conference
THOUSAND OAKS, Calif., May 12, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch 2017 Health Care Conference at 8 a.m. PT on Wednesday, May 17, 2017. 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 biology for patients suffe...
Source: Amgen News Release - May 12, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Harvard Pilgrim Agree To First Cardiovascular Outcomes-Based Refund Contract For Repatha ® (Evolocumab)
Harvard Pilgrim Refines the Utilization Management Criteria to Help High-Risk Cardiovascular Patients Access Repatha First-of-its-Kind Contract Will Demonstrate Value to Harvard Pilgrim Plans for Cardiovascular Patients THOUSAND OAKS, Calif., May 2, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced from the World Medical Innovation Forum™ focused on cardiovascular disease that Harvard Pilgrim, a health services company providing healthcare coverage for nearly 2.7 million customers in the northeast region of the U.S.,1 has signed an outcomes-based refund contract with Amgen for Repatha® (evolocumab)....
Source: Amgen News Release - May 2, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Participate In The 2017 World Medical Innovation Forum ™ Focused On Cardiovascular Disease
THOUSAND OAKS, Calif., April 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced plans to participate in the World Medical Innovation Forum™ focused on cardiovascular disease held May 1-3, 2017, in Boston. The World Medical Innovation Forum is a global gathering of senior corporate, investor and academic leaders. The forum was established to respond to the intensifying transformation of health care and its impact on innovation. This is the third year Amgen has participated in this event as a sponsor. Four senior leaders from Amgen are scheduled to speak: Robert A. Bradway, chairman and chief exe...
Source: Amgen News Release - April 27, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Participate In The 2017 World Medical Innovation Forum ™ Focused On Cardiovascular Disease
THOUSAND OAKS, Calif., April 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced plans to participate in the World Medical Innovation Forum™ focused on cardiovascular disease held May 1-3, 2017, in Boston. The World Medical Innovation Forum is a global gathering of senior corporate, investor and academic leaders. The forum was established to respond to the intensifying transformation of health care and its impact on innovation. This is the third year Amgen has participated in this event as a sponsor. Four senior leaders from Amgen are scheduled to speak: Robert A. Bradway, chairman and chief exe...
Source: Amgen News Release - April 27, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Reports First Quarter 2017 Financial Results
THOUSAND OAKS, Calif., April 26, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2017. Key results include: Total revenues decreased 1 percent versus the first quarter of 2016 to $5.5 billion. GAAP earnings per share (EPS) increased 12 percent to $2.79 driven by higher operating margins. GAAP operating income increased 8 percent to $2.6 billion and GAAP operating margin increased 4 percentage points to 49.8 percent. Non-GAAP EPS increased 9 percent to $3.15 driven by higher operating margins. Non-GAAP operating income increased 5 percent to $...
Source: Amgen News Release - April 26, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Expanded Commercial Collaboration With Novartis For Erenumab In Migraine
Collaboration Designed to Maximize the Launch of First-in-Class Program and to More Effectively Reach People Living With Migraine THOUSAND OAKS, Calif., April 24, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced an expanded commercial collaboration with Novartis for erenumab, which is being investigated for the prevention of migraine. This expanded commercial collaboration builds on a global neuroscience collaboration in Alzheimer's disease and migraine established in 2015 between Novartis and Amgen. This expanded collaboration leverages Novartis' strong and established presence in neuroscience to more ef...
Source: Amgen News Release - April 24, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Webcast Of 2017 First Quarter Financial Results
THOUSAND OAKS, Calif., April 21, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its first quarter financial results on Wednesday, April 26, 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...
Source: Amgen News Release - April 21, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Launches Neulasta ® (pegfilgrastim) Onpro® NARRATIVES
Online News Resource Highlights Importance of Patient and Care Team Dialogue THOUSAND OAKS, Calif., April 18, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the launch of Neulasta® (pegfilgrastim) Onpro® NARRATIVES, an online media resource about the value of a cancer care team that provides comprehensive support for patients receiving strong chemotherapy. Intended to support conversations between cancer patients undergoing strong chemotherapy and their healthcare team about potential risk for infection due to a low white blood cell count, Neulasta Onpro NARRATIVES shares personal cancer stories ...
Source: Amgen News Release - April 18, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Submits Applications In The US And Europe To Expand Current Indication For XGEVA ® (denosumab) To Include Patients With Multiple Myeloma
XGEVA is Currently Indicated for the Prevention of Skeletal-Related Events Known as Bone Complications in Patients With Solid Tumors Applications Include Data From the Largest International Trial Conducted in Multiple Myeloma THOUSAND OAKS, Calif., April 4, 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) and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for XGEVA® (denosumab). The submissions to regulatory authorities seek to exp...
Source: Amgen News Release - April 4, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And UCB Report New Data At ENDO 2017 Examining The Option Of A Second Course Of Treatment With EVENITY ™ (romosozumab)
THOUSAND OAKS, Calif. and BRUSSELS, April 1, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced results from the fourth year of a Phase 2 study showing the efficacy and safety of a second course of treatment with EVENITY™* (romosozumab), an investigational agent for postmenopausal women with osteoporosis. The results were presented in an oral session (OR08-1) at ENDO 2017, the Endocrine Society's Annual Meeting in Orlando, Fla. In the study, postmenopausal women with low bone mass (lumbar spine, total hip or femoral neck T score between -2.0 and -3.5) were initially rand...
Source: Amgen News Release - April 1, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Highlight New Preclinical Data At The American Association For Cancer Research (AACR) Annual Meeting
Preclinical Results for Mcl-1 Inhibitor for Multiple Myeloma Accepted as Oral Presentation New Data on Bispecific T Cell Engagers (BiTE®) Immunotherapy Platform Preclinical Study Combining Different Immuno-Oncology Agents THOUSAND OAKS, Calif., March 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new preclinical data from its oncology portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting from April 1-5, 2017, in Washington, D.C. These data provide insights into the potential of Amgen's half-life optimized bispecific T cell engager (BiTE®) immun...
Source: Amgen News Release - March 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Grants Priority Review For Amgen's BLINCYTO ® (blinatumomab) Supplemental Biologics License Application
Application Includes Overall Survival Data From Phase 3 TOWER Study to Support Conversion From Accelerated Approval to Full Approval Acceptance Reinforces Significant Need for Innovative Treatment Options for Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia BLINCYTO is the First-and-Only Approved Bispecific CD19-Directed CD3 T Cell Engager (BiTE®) Immunotherapy THOUSAND OAKS, Calif., March 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCY...
Source: Amgen News Release - March 29, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Journal Of Clinical Oncology Publishes Data On BLINCYTO ® (Blinatumomab) In High-Risk Patients With Philadelphia Chromosome-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
BLINCYTO is the Only Bispecific T Cell Engager (BiTE®) Immunotherapy Approved in the U.S. Complete Remission or Complete Remission With Partial Hematologic Recovery was Induced in More Than 35 Percent of Patients THOUSAND OAKS, Calif., March 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Journal of Clinical Oncology published results from the Phase 2, open-label ALCANTARA study evaluating the efficacy and safety of BLINCYTO® (blinatumomab) in patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) who had fail...
Source: Amgen News Release - March 29, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Awards Three Golden Tickets for LabCentral Residency
Innovative Start-Up Companies Receive One-Year Free Lab Space CAMBRIDGE, Mass., March 28, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and LabCentral announced that Cocoon Biotech, Torus Therapeutics, and Holobiome are the winners of Golden Ticket awards. Sponsored by Amgen, the Golden Ticket awards underwrite the cost of a lab bench for a scientist from each organization to reside in LabCentral's open lab for one year. LabCentral is an innovative, shared laboratory space designed as a launchpad for premier high impact life-sciences and biotech startups. Amgen entered into a multi-year platinum-level sponsorship with...
Source: Amgen News Release - March 28, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

European Commission Approves AMGEVITA ™ (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases
First Biosimilar Adalimumab Approved in the European Union THOUSAND OAKS, Calif., March 23, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for AMGEVITA™ (biosimilar adalimumab1) in all available indications. AMGEVITA is authorized for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-s...
Source: Amgen News Release - March 23, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news