US FDA and CTTI pick patient advocates to boost engagement in trials
The advocates will work to enhance the US FDA’s understanding of how to best engage across patient communities, according to CTTI.
Archives for July 16, 2018
DIA 2018
WCG, InformedDNA team up to support clinical trials using genetics, as pipelines shift to highly targeted therapies
WCG and InformedDNA have established a new center for genetics and precision medicine in clinical trials – the increasing complexity of which, while potentially daunting, also creates the opportunity for transformational value, say industry experts.
UPDATED
Pfizer halts production at Hospira site after Form 483
Pfizer says it has voluntarily paused production at a manufacturing facility in India, after receiving a US FDA Form 483 with 11 observations.
New partnership connects researchers with global RWE/HEOR suppliers
The Scientist.com and HealthEconomics.com partnership connects real-world evidence (RWE) and health economic outcomes research (HEOR) sponsors and providers to help democratize pharmaceutical research, says company exec.
Russian CRO Atlant Clinical continues to grow 'despite certain political and economic challenges’
The Russia-based CRO Atlant Clinical has received certification in the organization and management of clinical trials – demand for which continues to increase despite political and economic challenges.
UPDATED
US FDA launches drug shortages task force
The US FDA announced a task force has been formed to prevent the shortage of drugs, by addressing the ‘underlying structural concerns’ that allow this to happen.
AMW owners sell up to YF Capital and Hybio Pharma
YF Capital, led by Alibaba co-founder, Jack Ma, and Hybio Pharmaceutical have led the acquisition of AMW, a developer of drug delivery systems.