Neulasta® (pegfilgrastim) Company Profile

16:49 EST 18th November 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 [47 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].

CMC data issues at Biocon plant prompt US FDA to reject Neulasta biosimilar

Mylan and Biocon have received a complete response letter for a version of Amgenâs Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.

Novartis: EMA Accepts Sandoz' Biosimilar Pegfilgrastim For Regulatory Review

BASEL (dpa-AFX) - Swiss drug giant Novartis AG (NVS) announced Friday that its division Sandoz' biosimilar to EU-authorized Neulasta (pegfilgrastim) has been accepted by the European Medicines Age...

FDA Issues CRL Seeking More Data on Biocon/Mylan Neulasta Biosimilar

Biocon has acknowledged that the FDA has held off approving its application with Mylan to market a biosimilar version of Amgen’s Neulasta ® (pegfilgrastim) pending submission of additional data...

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).

Mylan and Biocon Neulasta biosimilar knocked back by FDA

Mylan and Biocon’s biosimilar version of Amgen’s blockbuster, Neulasta (pegfilgrastim), will have to wait a bit longer before getting the nod from the FDA, after receiving a CRL related manufactur...

Biocon's biosimilars withdrawn in EU

Shares in Biocon have fallen after the company withdrew two filings for biosimilars in Europe because of ongoing concerns over its manufacturing facility. The company said the withdrawal of its Herce...

FDA rejects Mylan and Biocon biosimilar, citing manufacturing issues

A biosimilar from Mylan and Biocon has been rejected by the FDA because of manufacturing issues at a production plant in India. The companies have filed a biosimilar of Amgen’s long-lasting white b...

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 [7 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...

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-...

Assurance of Myeloid Growth Factor Administration in an Infusion Center: Pilot Quality Improvement Initiative.

Four incident reports involving missed doses of myeloid growth factors (MGFs) triggered the need for an outcome-driven initiative. From March 1, 2015, to February 29, 2016, at University of California...

Clinical Trials [142 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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