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EPOGEN® (Epoetin alfa) Company Profile

09:42 EDT 19th September 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 [124 Associated News Articles listed on BioPortfolio]

FDA panel recommends approval of Hospira’s Epogen biosimilar

Brian BerkThe committee’s recommendation was based on its review of the totality of evidence, including demonstration of comparable efficacy and safety of Pfizer’s biosimilar epoetin alfa ...

FDA for first time recommends approval for biosimilar erythropoiesis-stimulating agent

Brian BerkThe committee’s recommendation was based on its review of the totality of evidence, including demonstration of comparable efficacy and safety of Pfizer’s biosimilar epoetin alfa ...

FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all in...

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (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).

Pfizer’s Epogen/Procrit biosimilar wins US backing

Pfizer’s biosimilar of Amgen’s epoetin alfa (Epogen/Procrit) has won backing in the US for approval across all proposed indications.

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.

Pfizer's anemia biosimilar gets FDA panel recommendation

Pfizer's biosimilar to Amgen's Epogen, or epoetin alfa, has been recommended by the FDA's Oncologic Drugs Advisory Committee  -More- 

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 [44 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...

Low versus high dose erythropoiesis-stimulating agents in hemodialysis patients with anemia: A randomized clinical trial.

The increased risks of death and adverse events with erythropoiesis-stimulating agent (ESA) therapy targeting a higher hemoglobin level are established. It is uncertain whether the adverse effects of ...

Patient evaluation of the redesigned follitropin alfa pen injector.

We aimed to evaluate the overall impressions of learning and subsequent use of the redesigned GONAL-f® (follitropin alfa) pen injector by women with recent or current infertility requiring assisted r...

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.

Clinical Trials [940 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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