FDA Approves XGEVA(R) (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 -- (Healthcare Sales & Marketi... Biopharmaceuticals, Oncology, FDA Amgen, XGEVA, denosumab, Multiple Myeloma, bone protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 5, 2018 Category: Pharmaceuticals Source Type: news
FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 5, 2018 Category: Drugs & Pharmacology Source Type: news
NAMS 2017 Annual Meeting Overview NAMS 2017 Annual Meeting Overview
Drug holidays should not be taken when using denosumab; molecular breast imaging may outperform mammography; and other topics, as reviewed during the NAMS annual meeting.Medscape Ob/Gyn (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 8, 2017 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health Commentary Source Type: news
Generic vs Brand Bone Drug for Breast Cancer, Skeletal Mets Generic vs Brand Bone Drug for Breast Cancer, Skeletal Mets
Monthly denosumab more effective than zoledronic acid in delaying time to first skeletal-related events but over 2 years cost almost $350K more.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 18, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Confusion about long-term treatment of osteoporosis clarified
(The North American Menopause Society (NAMS)) Osteoporosis is a common disorder among postmenopausal women which results in an increased risk of fractures. While several therapies improve bone strength and reduce the risk of spine and hip fracture, there is no cure for osteoporosis, and long-term treatment is needed. An upcoming presentation at The North American Menopause Society (NAMS) Annual Meeting in Philadelphia Oct. 11-14 is scheduled to present new evidence about the long-term effectiveness and safety of treatment with bisphosphonates and denosumab. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - October 11, 2017 Category: International Medicine & Public Health Source Type: news
FDA Accepts Supplemental Biologics License Application For Prolia ® (Denosumab) In Glucocorticoid-Induced Osteoporosis
Glucocorticoid-Induced Osteoporosis is the Most Common Form of Secondary Osteoporosis
THOUSAND OAKS, Calif., Oct. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PD...
Source: Amgen News Release - October 9, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen Highlights The Latest EVENITY ™ (Romosozumab) And Prolia® (Denosumab) Research At The American Society For Bone And Mineral Research Annual Meeting
First Presentation of Detailed EVENITY ARCH Study Results and FRAME Extension Final Analysis
10-Year Data From Long-Term Prolia FREEDOM Study
THOUSAND OAKS, Calif., Sept. 8, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that 19 scientific abstracts will highlight the latest scientific research on EVENITY™* (romosozumab) and Prolia® (denosumab) at this year's Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Denver from Sept. 8-11, 2017.
"The data being presented at ASBMR underscore our steadfast focus for more than a decade to advance scientific understanding and care...
Source: Amgen News Release - September 8, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Prostate Cancer Patients Can Improve Bone Health With Osteoporosis Medications
Men with non-metastatic prostate cancer who receive androgen deprivation therapy risk loss of bone mineral density and fractures, but both bisphosphonates and denosumab can improve their bone health. (Source: CancerNetwork)
Source: CancerNetwork - August 8, 2017 Category: Cancer & Oncology Authors: Mark L. Fuerst Tags: Genitourinary Cancers News Prostate Cancer Source Type: news
Osteoporosis medications improve bone health in men being treated for prostate cancer
(American College of Physicians) Both biophosphonates and denosumab improve bone mineral density in men with nonmetastatic prostate cancer who are receiving androgen deprivation therapy. The results from a systematic review and meta-analysis are published in Annals of Internal Medicine. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - August 7, 2017 Category: Cancer & Oncology Source Type: news
Single Shot of Zoledronate Doesn't Preserve BMD After Denosumab Single Shot of Zoledronate Doesn't Preserve BMD After Denosumab
A single dose of zoledronate does not adequately preserve bone mineral density gains seen with long-term denosumab treatment, once the latter is discontinued.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 4, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Bone loss after denosumab, only partial protection with zoledronate
This report investigates whether a single infusion of zoledronate might also be an effective option to prevent bone loss after long-term denosumab treatment in postmenopausal patients is discontinued. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 2, 2017 Category: International Medicine & Public Health Source Type: news
Amgen Submits Supplemental Biologics License Application For Prolia ® (denosumab) In Glucocorticoid-Induced Osteoporosis
THOUSAND OAKS, Calif., July 31, 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) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
Osteoporosis can be caused by glucocorticoid medications, which are prescribed to treat inflammatory diseases. Within the first three months of beginning glucoco...
Source: Amgen News Release - July 31, 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
Denosumab Shows Benefits in Multiple Myeloma Bone Disease Denosumab Shows Benefits in Multiple Myeloma Bone Disease
In a head-to-head comparison with zoledronic acid, denosumab was noninferior, with prolonged time to a first skeletal event and a reduced risk for renal events.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 27, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
