June 28, 2017
Novartis’s Erelzi cleared in Europe
Novartis ahs won European clerance for Erelzi, as the European Commission approved it for Novartis’s division Sandoz.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: Sandoz
June 19, 2017
Novartis’s division wins EC approval for its cancer drug
European Commission (EC) has approved Sandoz’s Rixathon (biosimilar rituximab) for use in all indications of the reference medicine, MabThera.
May 31, 2017
Novartis warns of U.S. price pressure on Sandoz generics
Novartis warned on Wednesday that price pressure on its generics drugs in the United States has intensified in the second quarter, cutting into its Sandoz division’s sales growth in the world’s largest healthcare market.
November 18, 2015
FDA accepts Sandoz regulatory submission for a biosimilar of cancer drug pegfilgrastim
The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF).
October 2, 2015
FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept
Novartis company has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) – a tumor necrosis factor alpha (TNF-alpha) inhibitor.