Quality regulations lag behind modern understanding; FDA
Regulations have failed to keep pace with modern understanding about manufacturing and quality, a FDA director said.
Archives for February 15, 2012
Lonza denies completion of South African API plant deal
Lonza has denied reports it has signed a deal with the South African government to build a $210m (€159m) API plant, saying it is merely “in discussions” over plans.
FDA warning letter asks Merck KGaA to investigate all its sites
The US FDA expects Merck KGaA to do a “comprehensive and global assessment” of its sites after sending a warning letter to three plants.
Genentech warns of fake Avastin
Genentech is warning patients that counterfeiters have distributed fake Avastin, which lacks the API bevacizumab, in the US.
Ockham buys Nexus in bid to boost oncology trial offering
Ockham has expanded its oncology trial services offering through its acquisition of Nexus Oncology.
GLP tox capacity constraining, but slowly, Charles River says
GLP toxicology capacity is filling up after repeated cuts but it will be years until more space is needed, the CEO of Charles River said.