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NEUPOGEN® (Filgrastim) Company Profile

09:04 EST 18th November 2017 | BioPortfolio

NEUPOGEN® (Filgrastim) is Amgen’s first product indicated to decrease the incidence of infection (as manifested by febrile neutropenia)in certain cancer patients who are receiving chemotherapy.


News Articles [25 Associated News Articles listed on BioPortfolio]

FDA Accepts Adello Biologic’s Biosimilar Biologics License Application for a Proposed Filgrastim Biosimilar

U.S.-based Adello Biologics today announced that U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for a b...

Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Revision: 12, Authorised

Chemotherapy Induced Neutropenia CIN Market Insights, Epidemiology and Market Forecast2023 [Report Updated: 01032017] Prices from USD $4950

DelveInsight's Chemotherapy Induced Neutropenia CIN Market Insights, Epidemiologyand Market Forecast2023 Report provides an overview of the disease and global markettrends of the Chemotherapy Induced...

FDA accepts application for Adello’s filgrastim biosimilar

US-based biosimilars specialist Adello Biologics (Adello) announced on 11 September 2017 that the regulatory submission for its proposed filgrastim biosimilar had been accepted by the US Food and Drug...

Real-life data supports efficacy and safety of biosimilar filgrastim

Biosimilars of filgrastim are widely used in the prophylaxis of chemotherapy‐induced (CIN) and febrile neutropenia (FN). However, there are limited observational data on the use of granulocyte colon...

Apotex Dances the BPCIA Patent Dance with Amgen, But Claims It Does Not Need to Provide 180-Day Notice of Commercial Marketing

The Federal Circuit held in Amgen v. Sandoz that the so-called “patent dance” is optional for applicants  seeking approval of a biosimilar product under the abbreviated BPCIA pathway, as dis...

Kirin-Amgen Joint Venture To Become Wholly-Owned Subsidiary Of Amgen

$780 Million Payment to be Funded From Joint Venture's Existing Cash Holdings Kyowa Hakko Kirin to Continue as Licensee in Asia THOUSAND OAKS, Calif., Oct. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AM...

Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled...  

Drugs and Medications [4 Associated Drugs and Medications listed on BioPortfolio]

Neupogen [Physicians Total Care, Inc.]

Neupogen [AMGEN, INC]

NEUPOGEN (Filgrastim)

Neulasta [Physicians Total Care, Inc.]

These highlights do not include all the information needed to use Neulasta safely and effectively. See full prescribing information for Neulasta.Neulasta (pegfilgrastim) injection, for subcutaneous us...

Neulasta [AMGEN INC]

These highlights do not include all the information needed to use Neulasta safely and effectively. See full prescribing information for Neulasta. Neulasta (pegfilgrastim) injection, for subcutaneous u...

PubMed Articles [14 Associated PubMed Articles listed on BioPortfolio]

Addition of Filgrastim (Neupogen) for Clozapine Rechallenge in the Case of Parkinson Disease Patient.

Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia.

Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. Our...

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase 3, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration (FDA) for commercial use in the United States, marketed as Zarxio®. This phase 3 ...

Biosimilar G-CSF versus filgrastim and lenograstim in healthy unrelated volunteer hematopoietic stem cell donors.

The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report ...

Characterisation of the site-specific monoPEGylated rhG-CSF analogue pegteograstim.

We describe the characterisation of a novel monoPEGylated recombinant human granulocyte colony-stimulating factor analogue, pegteograstim (Neulapeg), prepared by site-specific 20 kDa maleimide-PEG co...

Clinical Trials [581 Associated Clinical Trials listed on BioPortfolio]

A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of ...

A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of ...

Fludarabine, Cytarabine, Filgrastim and Idarubicin in Core Binding Factor (CBF) Leukemias

The goal of this clinical research study is to learn if idarubicin can be added to the combination of fludarabine, cytarabine, and Neupogen (Filgrastim) without increasing the risk of side...

A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (REaCT-G2)

In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associ...

Post-ASCT Use of Zarzio®

There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on ha...

Companies [1 Associated Companies listed on BioPortfolio]

NEUPOGEN® (Filgrastim)

NEUPOGEN® (Filgrastim) is Amgen’s first product indicated to decrease the incidence of infection (as manifested by febrile neutropenia)in certain cancer patients who are receiving chemotherapy.

More Information about "NEUPOGEN® (Filgrastim)" on BioPortfolio

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

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