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Amgen ’s Mimpara for secondary HPT children with ESRD receives marketing approval in EU
US-based biopharmaceutical company Amgen has been granted marketing authorisation by the European Commission (EC) for Mimpara (cinacalcet) to treat secondary hyperparathyroidism (HPT) in children with end ‑stage renal disease (ESRD). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - August 31, 2017 Category: Pharmaceuticals Source Type: news

European Commission Approves Expanded Use Of Mimpara ® (Cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Children With End-Stage Renal Disease On Dialysis
THOUSAND OAKS, Calif., Aug. 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted Marketing Authorization of a pediatric formulation (granules in capsule for opening) of Mimpara® (cinacalcet) 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. "Secondary HPT is a serious and complex condition, and there are currently limited treatment options available for...
Source: Amgen News Release - August 31, 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. &quo...
Source: Amgen News Release - June 23, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Sensipar (Cinacalcet) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 6, 2017 Category: Drugs & Pharmacology Source Type: news

Etelcalcetide Lowers PTH in Patients on Dialysis Etelcalcetide Lowers PTH in Patients on Dialysis
Etelcalcetide lowered parathyroid hormone in patients with end-stage renal disease who were receiving dialysis compared with placebo or cinacalcet, but questions remain regarding clinical benefit.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 13, 2017 Category: Consumer Health News Tags: Nephrology News Source Type: news

Amgen's 2015 Revenues Increased 8 Percent To $21.7 Billion And Adjusted Earnings Per Share (EPS) Increased 19 Percent To $10.38
2015 GAAP EPS Were $9.06 2016 Total Revenues and Adjusted EPS Guidance Increased to $22.0-$22.5 Billion and $10.60-$11.00, Respectively THOUSAND OAKS, Calif., Jan. 28, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2015. Key results include: For the fourth quarter, total revenues increased 4 percent to $5,536 million, with 3 percent product sales growth driven by Enbrel® (etanercept), Sensipar® (cinacalcet), Prolia® (denosumab), Kyprolis® (carfilzomib) and XGEVA® (denosumab). Adjusted operating income grew 16 percent to...
Source: Amgen News Release - January 28, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Is cinacalcet cost effective in sHPT in the US?
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - January 1, 2016 Category: Drugs & Pharmacology Source Type: news

Is Cinacalcet Useful in Dialysis Patients?Is Cinacalcet Useful in Dialysis Patients?
Dr Jeffrey Berns reviews the latest research on cinacalcet's role in managing hemodialysis patients. Medscape Nephrology (Source: Medscape Nephrology Headlines)
Source: Medscape Nephrology Headlines - January 21, 2015 Category: Urology & Nephrology Tags: Nephrology Commentary Source Type: news

Cinacalcet May Protect Against Fracture in Dialysis
(MedPage Today) -- Subgroup analyses of EVOLVE trial found the drug helps dialysis patients. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 12, 2014 Category: Cardiology Source Type: news

Drug may help prevent bone fractures in patients on dialysis
In patients on dialysis, cinacalcet reduced the rate of bone fracture by 16% to 29%, after accounting for patient characteristics and other factors, researchers report. Patients with kidney failure who are undergoing dialysis have an increased risk of bone fractures, and the risk of dying after a hip fracture in such a patient is double that of the general population. Unfortunately, none of the approved drugs for fracture prevention in osteoporosis in the general population are approved for use in patients on dialysis, and some are actually contraindicated. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - December 11, 2014 Category: Science Source Type: news

CV Outcomes Better With Cinacalcet, But Only in the ElderlyCV Outcomes Better With Cinacalcet, But Only in the Elderly
Although the EVOLVE study failed to meet its end point, a new subanalysis shows that cinacalcet improves time to death and cardiovascular (CV) end points in older patients. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 10, 2014 Category: Consumer Health News Tags: Nephrology News Source Type: news

Cinacalcet in Primary HyperparathyroidismCinacalcet in Primary Hyperparathyroidism
How effective is this calcium-sensing receptor modulator in reducing serum calcium? Therapeutic Advances in Endocrinology and Metabolism (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 25, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

Cinacalcet Shows Little Benefit in End-Stage Kidney DiseaseCinacalcet Shows Little Benefit in End-Stage Kidney Disease
Cinacalcet reduces the need for parathyroidectomy in a few patients with chronic kidney disease but appears to have no effect on all-cause or cardiovascular mortality and comes with adverse effects. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 7, 2013 Category: Consumer Health News Tags: Nephrology News Source Type: news

No Mortality Benefit Seen for Dialysis Drug (CME/CE)
(MedPage Today) -- The routine use of the calcimimetic agent cinacalcet (Sensipar) conferred little mortality benefit in patients with severe chronic kidney disease and is commonly associated with side effects, a meta-analysis confirmed. (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - May 2, 2013 Category: Urology & Nephrology Source Type: news

Routine Prescribing Of Cinacalcet For End Stage Kidney Disease No Longer Warranted
Cinacalcet, a drug commonly given to patients with end stage kidney disease to help keep phosphorus and parathyroid blood levels within a target range and has few patient level clinical benefits and several adverse effects, suggesting that it should no longer be routinely prescribed, according to a study by international researchers published in this week's PLOS Medicine. These findings are important as cinacalcet has become the largest single drug cost for patients on dialysis in the US, with an annual expenditure of at least US $260 million... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - May 2, 2013 Category: Consumer Health News Tags: Urology / Nephrology Source Type: news

Routine Use Of Cinacalcet Therapy In People With Chronic Kidney Disease No Longer Recommended
Cinacalcet, a drug commonly given to patients with end stage kidney disease to help keep phosphorus and parathyroid blood levels within a target range has few patient level clinical benefits and several adverse effects, suggesting that it should no longer be routinely prescribed, according to a study by international researchers published in this week's PLOS Medicine. These findings are important as cinacalcet has become the largest single drug cost for patients on dialysis in the US, with an annual expenditure of at least US $260 million... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - May 2, 2013 Category: Consumer Health News Tags: Urology / Nephrology Source Type: news

FDA Suspends Sensipar Trials Following Death Of Teenager
The U.S. Food and Drug Administration recently announced it has stopped all pediatric clinical trials of the drug Sensipar, following the death of a 14 year old patient who took part in one of the studies. Sensipar is a drug, developed by Amgen Inc, that reduces the levels of calcium in the blood by decreasing the release of parathyroid hormone (PTH) from the parathyroid gland. Having high levels of calcium can be the cause of a number of health problems, it has been associated with an increased risk of heart attack... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - February 28, 2013 Category: Consumer Health News Tags: Clinical Trials / Drug Trials Source Type: news

FDA Suspends Pediatric Clinical Trials After Report Of Death
Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death   AUDIENCE: Health Professional, Endocrinology, Pediatrics ISSUE: FDA has stopped all pediatric clinical trials of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 27, 2013 Category: Pharmaceuticals Source Type: news

Death Halts Sensipar Trials in Kids
(MedPage Today) -- The FDA today suspended all pediatric clinical trials of cinacalcet hydrochloride (Sensipar) -- Amgen's calcium-sensing receptor agonist -- because of the death of a 14-year-old patient in one of the studies. (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - February 26, 2013 Category: American Health Source Type: news

Cinacalcet Trials Halted Due to Pediatric DeathCinacalcet Trials Halted Due to Pediatric Death
The studies were attempting to determine whether the calcium-lowering drug approved for adults also was safe and effective in treating children. News Alerts (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 26, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

FDA halts Amgen drug trial after 14-year-old dies
Amgen was testing its thyroid drug Sensipar -- which is approved to treat adults -- on children; FDA says it's unclear if drug had a role (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - February 26, 2013 Category: Consumer Health News Source Type: news

Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
FDA continues to gather information on the circumstances surrounding the patient’s death. (Source: FDA MedWatch)
Source: FDA MedWatch - February 26, 2013 Category: American Health Source Type: news

FDA halts trials of Amgen drug in children, cites death
(Reuters) - The U.S. Food and Drug Administration said on Tuesday it has stopped all pediatric clinical trials of Amgen Inc's Sensipar after the reported death of a 14-year-old patient taking part in a study of the drug used to lower calcium levels in the blood. (Source: Reuters: Health)
Source: Reuters: Health - February 26, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
Audience: Health Professional, Endocrinology, Pediatrics ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial.  Posting this information does not mean... (Source: Drugs.com - FDA MedWatch Alerts)
Source: Drugs.com - FDA MedWatch Alerts - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Amgen Outlines Long-Term Strategy
Amgen Emphasizes Pipeline, International Expansion and Biosimilars as Growth Drivers Pivotal Data from Eight Late-Stage Programs Anticipated Between 2013 and 2016 NEW YORK, Feb. 7, 2013 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) today... BiopharmaceuticalsAmgen, Enbrel, Prolia, XGEVA, Sensipar, Vectibix, Romosozumab (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 7, 2013 Category: Pharmaceuticals Source Type: news