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 bone. The ...
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 patient after...
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.
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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 president an...
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 f...
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 demonstrat...
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 med...
Source: Amgen News Release - January 29, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
