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Amgen Receives Positive Opinion Expanding Use Of XGEVA ® (denosumab) To Cover Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma In Europe
Application Based on Data From Largest International Multiple Myeloma Trial for the Prevention of Skeletal-Related Events Ever Conducted THOUSAND OAKS, Calif., Feb. 23, 2018 /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 to expand the current indication for XGEVA® (denosumab) to cover skeletal-related events in patients with multiple myeloma. If approved, XGEVA will be indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bon...
Source: Amgen News Release - February 23, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces FDA Advisory Committee Meeting To Review Potential New Use Of BLINCYTO ® (blinatumomab)
First-Ever Application to be Submitted for an MRD Positive Indication THOUSAND OAKS, Calif., Feb. 14, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the BLINCYTO® (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL) at a meeting on March 7, 2018. MRD refers to the presence of a small amount of detectible cancer cells that remain in the patien...
Source: Amgen News Release - February 14, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Results From Phase 3 XGEVA ® (Denosumab) Study In Patients With Multiple Myeloma Published In The Lancet Oncology
In this study, XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeleta... (Source: Amgen News Release)
Source: Amgen News Release - February 8, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The 7th Annual Leerink Partners Global Healthcare Conference
THOUSAND OAKS, Calif., Feb. 8, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 7th Annual Leerink Partners Global Healthcare Conference at 10 a.m. ET on Wednesday, Feb. 14, 2018, in New York City. 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 ...
Source: Amgen News Release - February 8, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen CEO Robert A. Bradway Becomes PhRMA Board Chairman
Olivier Brandicourt, CEO, Sanofi, James Robinson, president, Astellas Americas, assume new postsWashington, D.C. (February 7, 2018) — The Pharmaceutical Research and Manufacturers of America (PhRMA) held its board meeting today, officially welcoming three new elected officers. Robert A. Bradway, chairman and CEO, Amgen, became chairman of the PhRMA board of directors. Olivier Brandicourt, CEO, Sanofi was named chairman-elect and James Robinson, president, Astellas Americas assumed the role of board treasurer.Bradway formerly held the position of board treasurer and succeeds Joaquin Duato, executive vice presiden...
Source: Amgen News Release - February 7, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Reports Fourth Quarter And Full Year 2017 Financial Results
Expects to Increase Investments in Growth, Including a New U.S. Manufacturing Plant Announces 2018 Guidance Additional $10 Billion of Share Repurchases Authorized THOUSAND OAKS, Calif., Feb. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2017. Key results include: For the fourth quarter, total revenues decreased 3 percent versus the fourth quarter of 2016 to $5.8 billion. For the full year, total revenues decreased 1 percent to $22.8 billion. GAAP loss per share of $5.89 for the fourth quarter and GAAP earnings per share (EPS) of $2.69 fo...
Source: Amgen News Release - February 1, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives CHMP Positive Opinion To Add Updated Overall Survival Data To KYPROLIS ® (carfilzomib) Label
Label Variation to Include Overall Survival Data From Phase 3 ENDEAVOR Trial THOUSAND OAKS, Calif., Jan. 30, 2018 /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 recommending a label variation for KYPROLIS® (carfilzomib) to include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade® [bortezomib] and dexamethasone [Vd]). The ENDEAVOR trial ...
Source: Amgen News Release - January 30, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Webcast of 2017 Fourth Quarter and Full Year Financial Results
THOUSAND OAKS, Calif., Jan. 29, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its fourth quarter and full year 2017 financial results on Thursday, Feb. 1, 2018, 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...
Source: Amgen News Release - January 29, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Reports Aimovig ™ (Erenumab) Met All Primary And Secondary Endpoints In Unique Phase 3b Study In Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments
LIBERTY is the First Migraine Prevention Trial of its Kind Conducted Specifically in Patients Who Have Tried Multiple Therapies Without Success, and are in Need of Additional Treatment Options The Trial Met its Primary Endpoint of Percentage of Patients on Aimovig Achieving at Least a 50 Percent Reduction of Migraine Days Versus Placebo, and all Secondary Endpoints Results Add to the Consistent Efficacy, Safety and Tolerability Profile of Aimovig Across the Spectrum of Migraine, Even in More Difficult to Treat Patients THOUSAND OAKS, Calif., Jan. 22, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced po...
Source: Amgen News Release - January 22, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

European Commission Approves Amgen And Allergan's MVASI ® (Biosimilar Bevacizumab) For The Treatment Of Certain Types Of Cancer
Marketing Authorization Based on Global Development Program Showing MVASI is Highly Similar to Avastin® (Bevacizumab) First Biosimilar Bevacizumab Approved in the European Union THOUSAND OAKS, Calif., Jan. 18, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the European Commission (EC) has granted marketing authorization for MVASI® (biosimilar bevacizumab). MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers, including in combination with fluoropyrimidine-based chemotherapy for metastatic ...
Source: Amgen News Release - January 18, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Addition Of Overall Survival Data To KYPROLIS ® (carfilzomib) Label
Phase 3 Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Velcade® (Bortezomib) and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Overall Survival Results Support Use of KYPROLIS in Combination With Dexamethasone as New Standard of Care THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS&re...
Source: Amgen News Release - January 17, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Overall Survival Analysis From KYPROLIS ® (Carfilzomib) Phase 3 ASPIRE Trial Published in the Journal of Clinical Oncology
KYPROLIS, Lenalidomide and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Lenalidomide and Dexamethasone Alone in Patients With Relapsed or Refractory Multiple Myeloma Results Support Early Use of KYPROLIS at First Relapse THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Journal of Clinical Oncology published positive overall survival (OS) findings from the final analysis of the Phase 3 ASPIRE trial, which demonstrated that the addition of KYPROLIS® (carfilzomib) to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent ver...
Source: Amgen News Release - January 17, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

European Medicines Agency Accepts Filing For EVENITY ™ (Romosozumab)
Application Supported by Phase 3 Data in More Than 11,000 Postmenopausal Women and Men with Osteoporosis at Increased Risk of Fracture THOUSAND OAKS, Calif. and BRUSSELS, Jan. 7, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for EVENITY™* (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. If approved in Europe, EVENITY will be a novel osteoporosis treatment that increases bone formation and reduces bone ...
Source: Amgen News Release - January 8, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves XGEVA ® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma
Expansion of Indication Offers Patients a New Treatment Option Approval Based on Safety and Efficacy Data From the Largest International Multiple Myeloma Clinical Trial Ever Conducted THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The approval is based on...
Source: Amgen News Release - January 5, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The 36th Annual J.P. Morgan Healthcare Conference
THOUSAND OAKS, Calif., Jan. 4, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) will present at the 36th Annual J.P. Morgan Healthcare Conference at 8:30 a.m. PT on Tuesday, Jan. 9, 2018, in San Francisco. 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 from s...
Source: Amgen News Release - January 4, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Teams Up With Cambridge Biotech Community To Select Two Startups To Receive Golden Tickets At LabCentral
Amgen Golden Tickets Provide Innovative Startup Companies With Free Lab Space to Aid in Further Advancement of Their Science CAMBRIDGE, Mass., Dec. 14, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and LabCentral today announced that Kernal Biologics Inc. and QurAlis have won the Amgen Golden Ticket at LabCentral. The two Golden Ticket winners were chosen by an Amgen internal committee and live audience members at a "Quick Pitch" event hosted by Amgen at its Cambridge R&D and Operations facility on Dec. 11, 2017. Five finalists pitched their business plan to attendees where the audiences' input represented on...
Source: Amgen News Release - December 14, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces 15 Percent Increase In 2018 First Quarter Dividend
THOUSAND OAKS, Calif., Dec. 12, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.32 per share dividend for the first quarter of 2018. The dividend will be paid on March 8, 2018, to all stockholders of record as of the close of business on Feb. 15, 2018. This represents a 15 percent increase from that paid in each of the previous four quarters. 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 begi...
Source: Amgen News Release - December 12, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

KYPROLIS ® (carfilzomib) Extended Overall Survival In Patients With Relapsed Or Refractory Multiple Myeloma In Phase 3 ASPIRE Trial
Results Highlighted During Oral Presentation at ASH 2017 Addition of KYPROLIS to Lenalidomide and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Lenalidomide and Dexamethasone Alone Regulatory Applications Submitted in the U.S. to add ASPIRE Overall Survival Results to KYPROLIS Label THOUSAND OAKS, Calif., Dec. 11, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new results showing the positive overall survival (OS) findings from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of OS, demonstrating that the addition of KYPROLIS® (carfilzomib)...
Source: Amgen News Release - December 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Foundation Pledges Up To $500,000 In Relief To Victims Of The Southern California Wildfires
Amgen Foundation Commits $200,000 to the United Way of Ventura County to Support Their Urgent Relief Efforts THOUSAND OAKS, Calif., Dec. 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Amgen Foundation has pledged $500,000 to support victims of the Southern California wildfires. Of this commitment, $200,000 will be directed to the United Way of Ventura County to support their immediate relief efforts. The Foundation has also committed up to an additional $300,000 to support victims of the Southern California wildfires. "These devastating fires have caused significant damage to our co...
Source: Amgen News Release - December 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

New Data To Be Presented At ASH 2017 Underscore Amgen's Commitment To Improving Lives And Changing Outcomes For Patients With Difficult-To-Treat Blood Cancers
Positive Overall Survival Data From Phase 3 ASPIRE Trial on KYPROLIS® (Carfilzomib) in Relapsed Multiple Myeloma to be Highlighted in Oral Presentation Results From Several Abstracts Highlight the Potential of Amgen's Bispecific T Cell Engager (BiTE®) Platform as an Innovative Approach to Treating Blood Cancers FDA Grants Priority Review for BLINCYTO (Blinatumomab) Supplemental Biologics License Application in Minimal Residual Disease-Positive Acute Lymphoblastic Leukemia THOUSAND OAKS, Calif., Dec. 7, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new clinical data and analyses from 33...
Source: Amgen News Release - December 7, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Webcast Investor Call At ASH 2017
THOUSAND OAKS, Calif., Dec. 6, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition on Saturday, Dec. 9, 2017, at 11:30 a.m. ET. David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen, together with other members of Amgen's management team and a clinical investigator, will participate to discuss the Company's oncology program, including our BiTE® immunotherapy platform. Live audio of the investor call will be simultaneously broadcast over the I...
Source: Amgen News Release - December 6, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Amgen's Repatha ® (evolocumab) To Prevent Heart Attack And Stroke
Following FDA Priority Review, Repatha is the Only PCSK9 Inhibitor Approved to Reduce Risk of Heart Attack, Stroke and Coronary Revascularization THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1 "We are pleased that the FDA made the inclusion of our outcomes data...
Source: Amgen News Release - December 1, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Aimovig ™ (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention
Patients With Episodic Migraine Taking Aimovig Reported Significant and Meaningful Benefits Over Six Months, With Reduced Monthly Migraine Days and Acute Medication Use Fifty Percent of Patients Taking Aimovig 140 mg Had Their Migraine Days Cut by at Least Half - Nearly Three-Fold Higher Odds Compared to Placebo Patients Taking Aimovig Reported Reduced Physical Impairment and Improved Ability to Participate in Daily Activities Based on a Novel Patient-Reported Outcomes Tool Ninety Percent of Patients Completed the Six-Month Study; Data Reinforce the Safety and Tolerability Profile of Aimovig Consistently Seen in the ...
Source: Amgen News Release - November 29, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The Evercore ISI 2017 Biopharma Catalyst/Deep Dive Conference
THOUSAND OAKS, Calif., Nov. 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Evercore ISI 2017 Biopharma Catalyst/Deep Dive Conference on Thursday, Nov. 30, 2017, in Boston, beginning at 9:30 a.m. ET.  Elliott M. Levy, M.D., senior vice president of Global Development at Amgen, will present. 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 pat...
Source: Amgen News Release - November 27, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Launches The ENBREL Mini ™ Single-Dose Prefilled Cartridge With AutoTouch™ Reusable Autoinjector That Is Ergonomically Designed For Patients
Innovative Reusable Autoinjector Provides Additional Administration Option for Enbrel® (Etanercept) Users Awarded Arthritis Foundation Ease of Use (SM) Commendation THOUSAND OAKS, Calif., Nov. 17, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced that the ENBREL Mini™ with AutoTouch™ is now available in the United States (U.S.). Awarded the Arthritis Foundation Ease of UseSM Commendation, this new and innovative delivery system provides an additional administration option for appropriate ENBREL patients. The AutoTouch™ reusable autoinjector has an ergonomic design that includes feature...
Source: Amgen News Release - November 17, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

New Analyses Presented At AHA 2017 Show Repatha ® (evolocumab) Significantly Reduced Cardiovascular Events In Patients With Peripheral Artery Disease And In Patients With A History Of Heart Attacks
Data Support Use of Repatha to Reduce Risk of Recurrent Cardiovascular Events in Patients With History of Multiple Heart Attacks Additional Analysis Found That Patients With More Recent Heart Attacks Experienced Substantial Risk Reductions With Repatha Repatha Benefit in Peripheral Artery Disease Patients Presented at AHA Scientific Sessions 2017 and Simultaneously Published in "Circulation" THOUSAND OAKS, Calif., Nov. 13, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced five new subgroup analyses from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER) that s...
Source: Amgen News Release - November 13, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news