Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia(R) (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 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal... Biopharmaceuticals, Regulatory Amgen, Prolia, denosumab, Glucocorticoid-Induced, Osteoporosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 27, 2018 Category: Pharmaceuticals 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 helping patients suffering f...
Source: Amgen News Release - April 27, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
UAB-led study shows drug effectiveness in reducing glucocorticoid-induced bone loss
(University of Alabama at Birmingham) About one in every 100 people in the world takes glucocorticoids long term to treat immune-mediated diseases. However, glucocorticoids, such as prednisone, have a side effect -- they induce glucocorticoid-induced bone loss, causing an estimated yearly bone fracture rate of 5 percent. An alternative treatment option to the standard treatment now appears promising, according to an international study. Researchers compared the monoclonal antibody denosumab against a standard bisphosphonate. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 27, 2018 Category: International Medicine & Public Health 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 outstanding.
...
Source: Amgen News Release - April 24, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Benefits, Drawbacks to Denosumab Tx in ESRD
(MedPage Today) -- High rates of treatment-related hypocalcemia (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - April 12, 2018 Category: Endocrinology Source Type: news
Steroid-Induced Bone Loss Better Treated With Denosumab? Steroid-Induced Bone Loss Better Treated With Denosumab?
Denosumab found to be superior to risedronate in the treatment of steroid-induced osteoporosis at 12 months, at least in terms of BMD, among patients starting steroid therapy or those who remained on it.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 10, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology News 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 international t...
Source: Amgen News Release - April 3, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Amgen Receives Positive Opinion Expanding Use Of XGEVA(R) (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 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AMGN) today announ... Biopharmaceuticals, Oncology, Regulatory Amgen, XGEVA, denosumab, Multiple Myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 23, 2018 Category: Pharmaceuticals 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 bone. The ...
Source: Amgen News Release - February 23, 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
FDA Expands Use of Amgen's Blockbuster Drug FDA Expands Use of Amgen's Blockbuster Drug
Amgen Inc said on Friday that the U.S. Food and Drug Administration approved its drug, Xgeva, to prevent fractures in patients with multiple myeloma.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 8, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news
FDA Expands Use of Denosumab to Myeloma Patients FDA Expands Use of Denosumab to Myeloma Patients
Amgen Inc said on Friday that the U.S. Food and Drug Administration approved its drug, Xgeva, to prevent fractures in patients with multiple myeloma.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - January 8, 2018 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news
FDA expands use of Amgen's blockbuster drug
(Reuters) - Amgen Inc said on Friday that the U.S. Food and Drug Administration approved its drug, Xgeva, to prevent fractures in patients with multiple myeloma. (Source: Reuters: Health)
Source: Reuters: Health - January 5, 2018 Category: Consumer Health News Tags: healthNews 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 da...
Source: Amgen News Release - January 5, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
