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(R) (denosumab) To Include Multiple Myeloma Patients
FDA Sets PDUFA Target Action Date of Feb. 3, 2018
THOUSAND OAKS, Calif., June 19, 2017 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denos... Biopharmaceuticals, Oncology, FDA Amgen, XGEVA, denosumab, Multiple Myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 19, 2017 Category: Pharmaceuticals 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
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 analysis d...
Source: Amgen News Release - June 4, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Comparison of osteoporosis treatments for improving bone mineral density
After teriparatide, osteoporosis treatment with denosumab yields higher additional bone mineral density gain, compared with bisphosphonates, according to data presented at the European Congress of Endocrinology 2017.Medscape (Source: Society for Endocrinology)
Source: Society for Endocrinology - May 31, 2017 Category: Endocrinology Source Type: news
Denosumab Ups BMD More Than Bisphosphates After Teriparatide Denosumab Ups BMD More Than Bisphosphates After Teriparatide
Use of denosumab after stopping teriparatide yields a greater increase in bone-mineral density in postmenopausal women with severe osteoporosis than bisphosphonates, according to a retrospective analysis.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 25, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News 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 Annual Meeting ...
Source: Amgen News Release - May 17, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Medical News Today: Osteoporosis: ACP update treatment guidelines for preventing bone fractures
In revised guidelines, the ACP strongly advise that women with osteoporosis should be treated with bisphosphonates or denosumab to prevent bone fractures. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - May 9, 2017 Category: Consumer Health News Tags: Bones / Orthopedics Source Type: news
ACP Updates Guidelines on Treating Low Bone Density, Osteoporosis (FREE)
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Clinicians should offer alendronate, risedronate, zoledronic acid, or denosumab to women with osteoporosis to reduce the risk for hip and vertebral fractures (strong … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - May 9, 2017 Category: Primary Care Source Type: news
Guideline for treating low bone density or osteoporosis to prevent fractures
The American College of Physicians recommends in an evidence-based clinical practice guideline that physicians treat women with osteoporosis with bisphosphonates (alendronate, risedronate, or zoledronic acid) or denosumab, a biologic agent. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 8, 2017 Category: Science Source Type: news
Reassuring Long-term Safety Trends With Denosumab Treatment Reassuring Long-term Safety Trends With Denosumab Treatment
There appear to be no worsening safety trends when denosumab is used long term for the treatment of osteoporosis in postmenopausal women, according to the seven-year FREEDOM Extension trial.Reuters Health Information (Source: Medscape Orthopaedics Headlines)
Source: Medscape Orthopaedics Headlines - April 20, 2017 Category: Orthopaedics Tags: Rheumatology News Source Type: news
Osteoporosis drug found safe for postmenopausal women in long-term trial
A new clinical trial has shown the short- and long-term safety of the drug denosumab to treat postmenopausal osteoporosis. (Source: Health News - UPI.com)
Source: Health News - UPI.com - April 7, 2017 Category: Consumer Health News 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 expand the...
Source: Amgen News Release - April 4, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
