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December 08, 2015
Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.
December 02, 2015
Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.
November 30, 2015
While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.
A study backed by the Centre of Regenerative Medicine found that laminins are crucial cell components that could help aid the commercial production of stem cell therapies.
November 23, 2015
The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.
November 17, 2015
BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.
November 10, 2015
The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.