Search results for " BLA"
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA, FDA Briefing Document, Oncologic Drugs Advisory Committee Meeting, BLA 125646.
6. Novartis, “Oncologic Drugs Advisory Committee Briefing Document, Tisagenlecleucel (CTL019),” July 12, 2017…
Article
A Bright Future for the Plasma Fractionation Industry
There is still a very bright future for the plasma fractionation industry. That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful isla…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
…ecific patents will not be known, as the originator will not have filed them as part of the original BLA [biologics license application] as they would if the products were small molecules.”
Biosi…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…