Neulasta® (pegfilgrastim) Company Profile

01:51 EDT 20th September 2017 | BioPortfolio

Neulasta® (pegfilgrastim) is approved for once-per-cycle dosing to decrease the incidence of infection (as manifested by febrile neutropenia)in certain cancer patients who are receiving chemotherapy.

News Articles [42 Associated News Articles listed on BioPortfolio]

Biosimilar pegfilgrastim highly similar to Neulasta

Canada-based Apobiologix published analytical results demonstrating the similarity of their pegfilgrastim product to the US reference product, Amgen’s Neulasta (pegfilgrastim) [1].

Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta). FDA’s...  

Cinfa’s Pegfilgrastim Biosimilar Candidate Demonstrates Positive Results in Second Clinical Study

PAMPLONA, Spain | May 17, 2017 | Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development...

Adello Biologics starts phase I trial for pegfilgrastim biosimilar

US-based biosimilars specialist Adello Biologics has started a phase I clinical trial for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

FDA Rejects Coherus’ Application for Proposed Biosimilar to Amgen’s Neulasta

REDWOOD CITY, Calif., June 12, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete respo...

Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL

FDA issued a complete response letter to Coherus' application for a biosimilar version of Amgen's Neulasta (pegfilgrastim), giving Amgen a...  

Apotex petitions FDA over Neulasta biosimilars

Apotex, and its specialist biosimilars unit Apobiologix, submitted a Citizen Petition on 21 April 2017 to the US Food and Drug Administration (FDA). The petition requests that the agency requires all ...

Cinfa reports positive result on biosimilar drug

Cinfa Biotech said its drug candidate B12019, a biosimilar to Amgen's Neulasta, or pegfilgrastim, has met the primary and sec -More- 

Drugs and Medications [2 Associated Drugs and Medications listed on BioPortfolio]

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 [8 Associated PubMed Articles listed on BioPortfolio]

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...

On-Body Injector: An Administration Device for Pegfilgrastim.

Many chemotherapy regimens used today require the support of a 
granulocyte-colony-stimulating factor for the prevention of 
life-threatening neutropenia. In March 2015, a delivery method was intr...

Thoracic aortitis and aortic dissection following pegfilgrastim administration.

The patient was a 67-year-old woman with a history of advanced lung adenocarcinoma. Eight days after pegfilgrastim administration, her computed tomography scan revealed thickened bilateral common caro...

Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations.

Chemotherapy-induced febrile neutropenia (FN) causes treatment delays and interruptions and can have fatal consequences. Current guidelines provide recommendations on granulocyte colony-stimulating fa...

Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia.

The aim of this cohort study was to compare a condensed schedule of consolidation therapy with high-dose cytarabine on days 1, 2 and 3 (HDAC-123) with the HDAC schedule given on days 1, 3 and 5 (HDAC-...

Clinical Trials [140 Associated Clinical Trials listed on BioPortfolio]

Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy

The purpose of this study is to estimate the relationship between patient reported outcomes (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with or w...

Neulasta in Type 1 Diabetes

This study seeks to determine if giving a a 12 week course of Neulasta to people with recent onset type 1 diabetes is (1) safe and (2) can preserve insulin production.

Study to Assess the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 With Neulasta

This is a randomized, single-blind, single-dose, 2-period, crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injectio...

Efficacy and Safety Study With MYL-1401H and Neulasta

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvan...

Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019)...

Companies [3 Associated Companies listed on BioPortfolio]

Neulasta® (pegfilgrastim)

Neulasta® (pegfilgrastim) is approved for once-per-cycle dosing to decrease the incidence of infection (as manifested by febrile neutropenia)in certain cancer patients who are receiving chemotherapy.



TRACON Pharmaceuticals, Inc

Established in 2005 in New York as Lexington Pharmaceuticals, TRACON remains a privately held company. In April 2005, the company named Bert Liang as President and Chief Executive Officer and moved to...

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