Neulasta Company Profile

22:26 EDT 19th March 2018 | BioPortfolio



One Amgen Center Dr
Thousand Oaks
United States of America


Phone: (866) 822-4832.

News Articles [39 Associated News Articles listed on BioPortfolio]

Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta® (pegfilgrastim)

Innovative Neulasta® Onpro® Kit is Designed to Provide the Right Dose for Patients at the Right Time THOUSAND OAKS, Calif., Feb. 27, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that...

Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta

NewsAmgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta (peg...

Gedeon’s re-filed Neulasta biosimilar under EU review

European regulators have accepted a resubmission of Gedeon Richter’s biosimilar to Amgen’s Neulasta.

Biosimilar matches reference drug Neulasta

Sandoz's biosimilar of Neulasta, or pegfilgrastim, matched the reference product in a clinical trial, according to the compan -More- 

FDA's NDA And BLA Approvals: Xepi, Admelog, Ixifi

Original new drugs and biologics recently approved by US FDA.   

EU regulators to review Sandoz’ Neulasta biosimilar

The European Medicines Agency has accepted for review Novartis unit Sandoz’ biosimilar of Amgen’s Neulasta.

EMA to review Sandoz's Neulasta biosimilar

The European Medicines Agency accepted for review Sandoz's marketing authorization application for its biosimilar to Neulasta -More- 

First Biosimilar Neulasta In Final Stages Of EMA Review Process

A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in...   

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 [1 Associated PubMed Articles listed on BioPortfolio]

A Metabolomic and Lipidomic Serum Signature from Nonhuman Primates Administered with a Promising Radiation Countermeasure, Gamma-Tocotrienol.

The development of radiation countermeasures for acute radiation syndrome (ARS) has been underway for the past six decades, leading to the identification of multiple classes of radiation countermeasur...

Clinical Trials [36 Associated Clinical Trials listed on BioPortfolio]

A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-a...

Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta

This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.

Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy...

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.

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...

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...

More Information about "Neulasta" on BioPortfolio

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

Quick Search


Corporate Database Quicklinks

Searches Linking to this Company Record