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FDA Approves Prolia ® (Denosumab) For Glucocorticoid-Induced Osteoporosis
Fifth Indication for Prolia for Men and Women at High Risk of Fracture Receiving Systemic Glucocorticoid Therapy THOUSAND OAKS, Calif., May 21, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. This approval is based on data...
Source: Amgen News Release - May 21, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves Aimovig ™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention
Migraine is a Severe Neurologic Disease That Profoundly Impacts Millions of Patients in the United States Aimovig is the First and Only FDA-Approved Treatment to Block the Calcitonin Gene-Related Peptide Receptor (CGRP-R), Which Plays an Important Role in Migraine Aimovig was Consistently Shown to Reduce Monthly Migraine Days, Including in More Difficult-to-Treat Populations, With Many Patients Achieving at Least a 50 Percent Reduction THOUSAND OAKS, Calif., May 17, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-...
Source: Amgen News Release - May 17, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives European Commission Approval For Repatha ® (Evolocumab) To Prevent Heart Attack And Stroke In Adults With Established Cardiovascular Disease
New Indication Supports Amgen's Commitment to Reduce the Risk of Recurrent Cardiovascular Events Faced by Heart Attack and Stroke Survivors Amgen Announces Efforts to Improve Repatha's Affordability Across Europe for Payers who Significantly Expand Patient Access THOUSAND OAKS, Calif., May 16, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by ...
Source: Amgen News Release - May 16, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At The Bank of America Merrill Lynch 2018 Health Care Conference
THOUSAND OAKS, Calif., May 10, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch 2018 Health Care Conference at 10 a.m. PT on Tuesday, May 15, 2018. David W. Meline, executive vice president and chief financial officer at Amgen, and David M. Reese, senior vice president of Translational Sciences and Oncology 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. Ab...
Source: Amgen News Release - May 10, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives Positive CHMP Opinion To Add Overall Survival Results From The Phase 3 ASPIRE Study To KYPROLIS ® (carfilzomib) Label
KYPROLIS is the First and Only Relapsed or Refractory Multiple Myeloma Treatment to Demonstrate Overall Survival in two Phase 3 Studies THOUSAND OAKS, Calif., April 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 the final overall survival (OS) data from the Phase 3 ASPIRE trial. The ASPIRE trial demonstrated that the addition of KYPROLIS to lenalidomide and dexamethasone (KRd) reduced the risk of deat...
Source: Amgen News Release - April 30, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia ® (denosumab) To Patients With Glucocorticoid-Induced Osteoporosis
Treats Bone Loss in Patients Using Glucocorticoid Medications who are at Increased Risk of Fracture THOUSAND OAKS, Calif., April 27, 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 for the marketing authorization of Prolia® (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. "Today's positive opinion by the CHMP is an important step for Prolia in help...
Source: Amgen News Release - April 27, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Reports First Quarter 2018 Financial Results
THOUSAND OAKS, Calif., April 24, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2018. Key results include: Total revenues increased 2 percent versus the first quarter of 2017 to $5.6 billion. Product sales grew 3 percent globally. All new and recently launched products including Repatha® (evolocumab), KYPROLIS® (carfilzomib), Prolia® (denosumab) and XGEVA® (denosumab) showed double-digit growth. GAAP earnings per share (EPS) increased 16 percent to $3.25 driven by higher product sales, a lower tax rate and lower weighted-average shares...
Source: Amgen News Release - April 24, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Webcast Of 2018 First Quarter Financial Results
THOUSAND OAKS, Calif., April 19, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its first quarter 2018 financial results on Tuesday, April 24, 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 media, investors ...
Source: Amgen News Release - April 19, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig ™ (erenumab) For Migraine Patients With Multiple Treatment Failures
The LIBERTY Trial was Conducted in Patients who Have Tried Two to Four Therapies Without Success -- a Uniquely Difficult-to-Treat Population Often Excluded From Migraine Prevention Trials Patients Taking Aimovig had Nearly Three-Fold Higher Odds of Having Their Migraine Days cut by Half or More Compared to Placebo Safety and Tolerability Were Consistent With Results Seen in the Pivotal Clinical Program; Over 97 Percent of Those Taking Aimovig Completed the Double-Blind Treatment Phase Data Selected by the American Academy of Neurology Science Committee as one of the Most Noteworthy Presentations at 2018 Annual Meetin...
Source: Amgen News Release - April 17, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Rhode Island Will Be Location Of First US Next-Generation Biomanufacturing Plant
Revolutionary, Innovative Plant Offers Greater Flexibility, Speed and Efficiency THOUSAND OAKS, Calif., April 10, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States (U.S.), will employ Amgen's proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets. A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built ...
Source: Amgen News Release - April 10, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present New Pre-Clinical Data Showcasing Robust Approach To Evaluating Potential Anti-Cancer Therapies At AACR 2018
First Data Presentations for CAR T Programs, Including DLL3 in Small Cell Lung Cancer and FLT3 in Acute Myeloid Leukemia Pre-Clinical Data Evaluating Half-Life Extended Anti-BCMA BiTE® Presented for First-Time New Data Include two Studies Investigating Mcl-1 Inhibitor AMG 176 THOUSAND OAKS, Calif., April 9, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that new pre-clinical data for several of its novel investigational oncology candidates will be presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 14-18, 2018. Data spans Amgen's ...
Source: Amgen News Release - April 9, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

European Commission Approves Expanded Indication For Amgen's XGEVA ® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma
This Approval was Based on the Largest International Trial Ever Conducted for the Prevention of Skeletal-Related Events in Multiple Myeloma Patients THOUSAND OAKS, Calif., April 2, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved an expanded indication for XGEVA® (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone. The indication now covers patients with bone metastases from solid tumors and those with multiple myeloma. The approval is based on data from the Phase 3 '482 study, the largest internat...
Source: Amgen News Release - April 3, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

FDA Approves BLINCYTO ® (blinatumomab) To Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia In Adults And Children
BLINCYTO is the First-and-Only FDA-Approved Therapy for Minimal Residual Disease Detection of Remaining Cancer Cells After Complete Remission is the Strongest Prognostic Factor for Relapse in Patients With Acute Lymphoblastic Leukemia Accelerated Approval Based on Data From the Phase 2 BLAST Study, the Largest Prospective Trial in Minimal Residual Disease-Positive Acute Lymphoblastic Leukemia THOUSAND OAKS, Calif., March 29, 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 BLINCYTO® (bl...
Source: Amgen News Release - March 29, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives Positive CHMP Opinion Recognizing That Repatha ® (evolocumab) Prevents Heart Attacks And Strokes
Recommended Label Includes New Indication Based on the Repatha Cardiovascular Outcomes Study (FOURIER) Amgen Continues to Work Closely With Payers on a Country-by-Country Basis to Ensure Access to Repatha for High-Risk Cardiovascular Patients THOUSAND OAKS, Calif., March 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 include a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarc...
Source: Amgen News Release - March 23, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Allergan Receive Positive CHMP Opinion For ABP 980 (Biosimilar Herceptin ®) For The Treatment Of Three Types Of Cancer
Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer THOUSAND OAKS, Calif., March 23, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) 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 ABP 980, a biosimilar to Herceptin® (trastuzumab). ABP 980 has been recommended for approval for the treatment of the same three types of...
Source: Amgen News Release - March 23, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

New Analyses Show Payer Utilization Management Criteria Deny Access To PCSK9 Inhibitors For Patients At The Highest Risk For Subsequent Cardiovascular Events
Research Presented at American College of Cardiology's 67th Annual Scientific Session Reveals More Than 110,000 Cardiovascular Events a Year Could Occur in High-Risk Patients With Cardiovascular Disease who are Rejected Access Additional Study Calls for Assessment of Utilization Management Processes to Improve Access for Appropriate Patients and Prioritize Patients at the Highest Risk for Subsequent Cardiovascular Events THOUSAND OAKS, Calif., March 9, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced data from two new studies exploring barriers to access for PCSK9 inhibitors and the potential...
Source: Amgen News Release - March 9, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Final Results Of Tender Offer
THOUSAND OAKS, Calif., March 8, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the final results of its modified Dutch auction tender offer, which expired at 12:00 Midnight, New York City time, at the end of Monday, March 5, 2018. Amgen has accepted for purchase 52,083,333 shares of its common stock, $0.0001 par value per share, at a price of $192 per share, for an aggregate cost of approximately $10 billion, excluding fees and expenses relating to the tender offer. These shares represent approximately 7.2 percent of the shares outstanding. The tender offer was oversubscribed and pursuant to the terms o...
Source: Amgen News Release - March 8, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces 2018 Second Quarter Dividend
THOUSAND OAKS, Calif., March 7, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.32 per share dividend for the second quarter of 2018. The dividend will be paid on June 8, 2018, to all stockholders of record as of the close of business on May 17, 2018. 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 t...
Source: Amgen News Release - March 7, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present At the Cowen and Company 38th Annual Health Care Conference
THOUSAND OAKS, Calif., March 7, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen and Company 38th Annual Health Care Conference at 1:30 p.m. ET on Monday, March 12, 2018, in Boston. 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 s...
Source: Amgen News Release - March 7, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Announces Preliminary Results Of Tender Offer
THOUSAND OAKS, Calif., March 6, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the preliminary results of its modified Dutch auction tender offer, which expired at 12:00 Midnight, New York City time, at the end of March 5, 2018. Based on the preliminary count by American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, a total of 54,297,698 shares of Amgen's common stock, $0.0001 par value per share, were properly tendered and not properly withdrawn at or below the purchase price of $192 per share, including 33,745,174 shares that were tendered by notice of guaranteed delivery. Amg...
Source: Amgen News Release - March 6, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta ® (pegfilgrastim)
Innovative Neulasta® Onpro® Kit is Designed to Provide the Right Dose for Patients at the Right Time THOUSAND OAKS, Calif., Feb. 27, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta® (pegfilgrastim) to include the Neulasta® Onpro® Kit. The Neulasta Onpro Kit combines the efficacy of Neulasta with an innovative on-body injector (OBI) delivery system. Neulasta is indicated in the European Union (EU) for the re...
Source: Amgen News Release - February 27, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen To Present New Data From Repatha ® (evolocumab) Clinical Trials At ACC.18
Presentations Focus on Patients With Established Cardiovascular Disease and Include Data Exploring Consistency of LDL-C Reduction With Repatha New Data Shows Patients at High Risk for Cardiovascular Events Continue to be Denied PCSK9 Inhibitors THOUSAND OAKS, Calif., Feb. 26, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new data from the Repatha® (evolocumab) clinical trial program to be featured at the American College of Cardiology's 67th Annual Scientific Session (ACC.18) in Orlando, Fla., March 10-12, 2018. Presentations to include additional analyses from the Repatha cardiovascular ou...
Source: Amgen News Release - February 26, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

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