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 Fee Act (PDUFA...
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.
Non-GAAP E...
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 monoclonal antibody targ...
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 that builds ...
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 safety data f...
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 for K...
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 than 35 years of ex...
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 of o...
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 TOWER study. T...
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 efforts...
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 NRAS as d...
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.
"We are ple...
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-Related Eve...
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 myeloma patien...
Source: Amgen News Release - June 19, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
