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EPOGEN® (Epoetin alfa) Company Profile

01:31 EST 18th November 2017 | BioPortfolio

EPOGEN® (Epoetin alfa), one of the first biologic human therapeutics, is approved for the treatment of anemia in patients with chronic kidney disease who are on dialysis.


News Articles [93 Associated News Articles listed on BioPortfolio]

Hospira to pay Amgen US$70 million for epoetin alfa patent infringement

US-based injectables specialist Hospira has been ordered to pay Biotech giant Amgen US$70 million in damages regarding a patent on Amgen’s anaemia blockbuster Epogen (epoetin alfa).

Pfizer gets CRL on Epogen biosimilar from FDA

The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).

Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal, epoetin alfa, Revision: 18, Authorised

FDA rejects Pfizer’s epoetin alfa biosimilar

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application for approval of its epoetin alfa biosimilar.

FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the ...

Update provided on Pfizer’s proposed epoetin alfa biosimilar

Pfizer has provided an update on its biologics licence application (BLA) for its proposed epoetin alfa biosimilar after receiving a complete response letter (CRL) from the US Food and Drug Administrat...

Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Revision: 17, Authorised

Human medicines European public assessment report (EPAR): Abseamed, epoetin alfa, Revision: 18, Authorised

Drugs and Medications [62 Associated Drugs and Medications listed on BioPortfolio]

Ribavirin [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use ribavirin safely and effectively. See full prescribing information for ribavirin tablets. Ribavirin Tablets Initial U.S. Approval: 200...

Epogen [AMGEN, INC]

These highlights do not include all the information needed to use Epogen safely and effectively. See full prescribing information for Epogen. Epogen(epoetin alfa)injection, for intravenous or subcutan...

Ribavirin [Sandoz Inc]

These highlights do not include all the information needed to use RIBAVIRIN TABLETS safely and effectively. See full prescribing information for RIBAVIRIN TABLETS. Ribavirin Tablets, oralInitial U.S. ...

Ribavirin [Zydus Pharmaceuticals (USA) Inc.]

These highlights do not include all the information needed to use ribavirin safely and effectively. See full prescribing information for ribavirin. Initial U.S. Approval: 2002

Ribavirin [Cadila Healthcare Limited]

These highlights do not include all the information needed to use ribavirin safely and effectively. See full prescribing information for ribavirin. Initial U.S. Approval: 2002

PubMed Articles [43 Associated PubMed Articles listed on BioPortfolio]

Asymmetric Synthesis of alfa,alfa-Disubstituted Allylic Amines via Pd-Catalyzed Allylic Substitution.

The first asymmetric synthesis of important alfa,alfa-disubstituted N-alkyl allyl amine scaffolds via allylic substitution is reported. This approach is based on palladium catalysis and features ample...

Tale of Two Erythropoiesis-Stimulating Agents: Utilization, Dosing, Litigation, and Costs of Darbepoetin and Epoetin Among South Carolina Medicaid-Covered Patients With Cancer and Chemotherapy-Induced Anemia.

The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and we...

Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial.

To compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants.

Biosimilars: Implications for Clinical Practice.

In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the...

Thrombomodulin alfa attenuates the procoagulant effect and cytotoxicity of extracellular histones through the promotion of protein C activation.

Extracellular histones are reported to increase thrombin generation in the plasma and induce endothelial cell death in vitro. These effects of histones were suggested to involve histone-induced inhibi...

Clinical Trials [948 Associated Clinical Trials listed on BioPortfolio]

A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin

The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen,) based on maintenance of hemoglobin (Hb) levels and s...

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with an...

The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing the transfusion requirements in anemic patients with multiple myeloma, and ...

Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy

The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on ...

The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer rece...

Companies [25 Associated Companies listed on BioPortfolio]

EPOGEN® (Epoetin alfa)

EPOGEN® (Epoetin alfa), one of the first biologic human therapeutics, is approved for the treatment of anemia in patients with chronic kidney disease who are on dialysis.

Assisted Living Federation of America (ALFA)

The Assisted Living Federation of America (ALFA) is the largest national association exclusively dedicated to professionally managed assisted living communities and the seniors an...

Alfa Laval

Alfa Laval is a leading global provider of specialized products and engineered solutions. Our equipment, systems and services are dedicated to helping customers to optimize the performance of their pr...

Assisted Living Federation of America

The Assisted Living Federation of America (ALFA) is the largest national association exclusively dedicated to professionally managed assisted living communities and the seniors and families they serve...

Alfa Wassermann, Inc

Under one name or another, Alfa Wassermann, Inc. has provided high quality products and services to the health care community since 1960. Our parent company, the Alfa Wassermann Group, headquartered i...

More Information about "EPOGEN® (Epoetin alfa)" on BioPortfolio

We have published hundreds of EPOGEN® (Epoetin alfa) news stories on BioPortfolio along with dozens of EPOGEN® (Epoetin alfa) Clinical Trials and PubMed Articles about EPOGEN® (Epoetin alfa) for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of EPOGEN® (Epoetin alfa) Companies in our database. You can also find out about relevant EPOGEN® (Epoetin alfa) Drugs and Medications on this site too.

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Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


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