logo
Plus   Neg
Share
Email

Sandoz Resubmits BLA For Proposed Biosimilar Pegfilgrastim To FDA - Quick Facts

Sandoz, a Novartis division, announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US FDA to address an FDA complete response letter received in June 2016. The resubmission includes new data from a pivotal pharmacokinetics and pharmacodynamics study.

Sandoz said it is pursuing approval of biosimilar pegfilgrastim to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company said the new data was from a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The National Retail Federation or NRF said that conflicting economic data amid a resurgence in coronavirus cases has made it difficult to predict how steadily the U.S. economic recovery will continue. NRF Chief Economist Jack Kleinhenz noted that based on quarterly and monthly data, the U.S. economic recovery is continuing despite the elevated COVID-19 cases. Ford Motor Company (F) announced that Jim Hackett plans to retire as President and CEO. He will continue as a special advisor to the company through March of 2021. The company has named Jim Farley as new president and CEO. He will join the board of directors, effective Oct. 1. Farley joined Ford in... Google parent Alphabet Inc. has issued $5.75 billion in sustainability bonds, becoming the largest green or sustainability bonds issued by a company until now. This is part of a $10 billion debt offering. Alphabet said the proceeds will be used to fund projects that are environmentally or socially responsible.
Follow RTT