DIA 2016
Fatality in clinical trials: DIA panel discusses FIH trials
After the Bial trial tragedy earlier this year, panelists gathered at DIA to discuss what went wrong and how to move forward as an industry.
Archives for June 28, 2016
New Veeva system combines CTMS and eTMF in the cloud
Veeva Systems has introduced Veeva Vault CTMS, a new application that brings together information, documentation, and processes in the cloud.
Sartorius $90m IntelliCyt acquisition adds cell analysis capabilities
Sartorius has expanded its bio-analytics capabilities through the $90m (€81m) acquisition of IntelliCyt.
“There are units that are doing first-in-human studies that frankly have no business doing them”
DIA: Calls for set standards in Phase I studies following Bial trial tragedy
Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.
NIH Deputy Director: manufactured stem cells to advance clinical research
Researchers supported by the National Institutes of Health (NIH) have developed a clinical-grade stem cell line, which will help accelerate early-stage clinical research.
Yellow fever outbreak: Sanofi looks to double vaccine production
A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa.
US FDA slams two Chinese API makers for quality systems and data issues
Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.