CRO launches stat monitoring tech in line with ICH GCP addendum
Quanticate has launched an upgraded statistical monitoring service following the ICH’s good clinical practice (GCP) E6(R2) addendum designed to streamline clinical trials.
Archives for November 21, 2017
Emergent BioSolutions strengthens manufacturing infrastructure with FDA-licensure
The US Food and Drug Administration (FDA) has approved Emergent BioSolutions’ supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, the only FDA-licensed smallpox vaccine, as the company looks to expand its CMO services.
Oregon drugmaker feels heat as FDA says to get out the kitchen
The US FDA has slammed Ridge Properties for making drug products using “kitchen utensils and cookware” in a warning letter sent last month.
CROs, pharma to increase staff dedicated to real world data collection by 25%, Tufts report
The industry is expected to use an increasing amount of real world evidence, including social media data, which will be used to support new drug applications, according to a recent Tufts report.
Boehringer Ingelheim selling molecules, crowdsourcing research proposals
Boehringer Ingelheim has launched a new platform through which it will offer open access to selected preclinical molecules in order to 'unlock the full potential' of compounds no longer under development by the company.
London to Amsterdam in 16 months a ‘demanding challenge’ says EMA
European member states have selected Amsterdam as the post-Brexit home of the European Medicines Agency, following a secret ballot vote in Brussels yesterday.
Pfizer demands return of drugs set for use in US lethal injections
The Big Pharma firm says it strongly objects to its products being used for capital punishment and has asked 31 states to return drugs.