First-to-file race slowing QbD adoption in generics
Generic manufacturers can benefit from QbD but fears it will hinder companies in the race to be first-to-file are slowing progress, a VP at Teva said.
Archives for August 7, 2011
EC revises stability testing
The EC has updated stability testing guidance to cover procedures for variations, such as change in batch size, to marketing authorisations.
ICIG takes Roche Colorado in bid to flex contract peptide manufacturing muscle
International Chemical Investors Group (ICIG) will take over Roche’s Colorado API plant in a bid to gain footing in the peptide manufacturing industry.
Big pharma thirst for pre-IND services driving CRL deals
Charles River is hunting for acquisitions with capabilities to meet big pharma’s newfound interest in discovery services.
Apps turn iPads & iPods into consent & compliance tools
Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.