Cipla settles case with Amgen Inc involving generic cinacalcet hydrochloride tablets
A formal stipulation of dismissal has been filed with the court and is awaiting signature by the presiding Judge, the filing added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 19, 2020 Category: Pharmaceuticals Source Type: news
Amgen sues Durham generics company
California-based biopharmaceutical company Amgen (Nasdaq: AMGN) has filed a patent infringement lawsuit against growing generics company Accord Healthcare and parent company Intas Pharmaceuticals.
Amgen's lawsuit stems from Accord Healthcare's plans to manufacture and sell a generic version of Amgen's drug, Sensipar, for the management of a type of hyperparathyroidism that causes detrimentally-high levels of calcium in the body. Sensipar raked in about $1.7 billion in revenue for Amgen l ast year.
According… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 3, 2018 Category: American Health Authors: Jennifer Henderson Source Type: news
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 pediatric patie...
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.
"We are ple...
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 $2,366 million and...
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
