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 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
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
Actonel (Risedronate Sodium) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 6, 2016 Category: Drugs & Pharmacology Source Type: news
Atelvia (Risedronate Sodium Delayed-Release Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 31, 2016 Category: Drugs & Pharmacology Source Type: news
Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia ® (Denosumab) In Patients Receiving Glucocorticoid Therapy
Study Indicates That Prolia Led to Greater Gains in Bone Mineral Density at 12 Months Compared With Risedronate in Patients Receiving Glucocorticoid Therapy
THOUSAND OAKS, Calif., Aug. 29, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive top-line results from the primary analysis conducted in a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia® (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. The study met all primary and secondary endpoints at 12 months. The data showed that treatment with Proli...
Source: Amgen News Release - September 17, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Osteoporosis Treatment Alternatives To Bisphosphonates
Big Pharma employs a lot of very serious spin-doctors. I’ll give you a good example.
Bisphosphonates For Osteoporosis?
A new study just came out on bisphosphonate drugs. These are the most commonly prescribed drugs for osteoporosis. They’re worth about $8.5 billion per year to the drug companies.
But this new study says that one-third of the women taking these drugs are still at high risk for fractures.
Now here’s what you have to understand. The study was done by a subsidiary of Merck & Co. They make Fosamax, one of the biggest bone drugs. So instead of saying the drugs don’t work ...
Source: Al Sears, MD Natural Remedies - September 6, 2016 Category: Complementary Medicine Authors: Al Sears Tags: Health Source Type: news
Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia ® (Denosumab) In Patients Receiving Glucocorticoid Therapy
Study Indicates That Prolia Led to Greater Gains in Bone Mineral Density at 12 Months Compared With Risedronate in Patients Receiving Glucocorticoid Therapy
THOUSAND OAKS, Calif., Aug. 29, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive top-line results from the primary analysis conducted in a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia® (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. The study met all primary and secondary endpoints at 12 months. The data showed that treatment with Proli...
Source: Amgen News Release - August 29, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
risedronate (Actonel, Actonel with Calcium, Atelvia)
Title: risedronate (Actonel, Actonel with Calcium, Atelvia)Category: MedicationsCreated: 3/12/2000 12:00:00 AMLast Editorial Review: 8/5/2016 12:00:00 AM (Source: MedicineNet Womens Health General)
Source: MedicineNet Womens Health General - August 5, 2016 Category: OBGYN Source Type: news
Fearing Drugs’ Rare Side Effects, Millions Take Their Chances With Osteoporosis
Use of the most commonly prescribed osteoporosis drugs fell 50 percent from 2008 to 2012 after reports of rotting jaws and snapped thighbones. (Source: NYT Health)
Source: NYT Health - June 2, 2016 Category: Consumer Health News Authors: GINA KOLATA Tags: Bones Osteoporosis Drugs (Pharmaceuticals) Medicine and Health Bone Fractures alendronate ibandronate risedronate zoledronate Source Type: news
Aurobindo gets USFDA nod to market generic Osteoporosis drug
Aurobindo PharmaBSE 1.80 % has confirmed that it has received final approval from USFDA to manufacture and market generic version of Risedronate Sodium tablets, used in the treatment of osteoporosis, in the American market.
Economic Times (Source: Society for Endocrinology)
Source: Society for Endocrinology - December 1, 2015 Category: Endocrinology Source Type: news
Aurobindo gets USFDA nod to market generic Osteoporosis drug
The company has received final approval from US Food & Drug Administration (USFDA) to manufacture and market Risedronate Sodium tablets, Aurobindo Pharma said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 1, 2015 Category: Pharmaceuticals Source Type: news
Dental implant protocol for patient on Actonel?
I have an implant patient that has been taking Actonel for 3 months. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - May 16, 2014 Category: Dentistry Authors: osseonews Tags: Dental Implant Cases Source Type: news
Calcium and vitamin D improve bone density in patients taking antiepileptic drugs
A recent prospective, randomized, placebo-controlled clinical trial reports that calcium and vitamin D supplementation improves bone density in a group of male veterans with epilepsy who were treated chronically with antiepileptic drugs (AEDs). The results published in Epilepsia, a journal of the International League Against Epilepsy (ILAE), suggest that risedronate, a bisphosphonate, may help to prevent new vertebral fractures when taken with calcium and vitamin D supplementation... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 11, 2013 Category: Consumer Health News Tags: Epilepsy Source Type: news
