CROs, Sponsors recognize need for improvement, opportunities
According a recent survey, while there is a disconnect between Sponsors and Providers in some areas, the industry as a whole agrees that there is room for improvement.
Archives for July 25, 2016
EMA proposing changes to FIH clinical trials, accepting comments
The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.
US FDA won't OK eye pain candidate until Ocular Therapeutix addresses production concerns
The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
Single-use driving double digit growth for Pall and Sartorius
Bioprocess equipment vendors Pall and Sartorius have each cited demand for single-use technologies as a growth driver in the first half 2016.
US FDA finds cGMP deviations at ALK-Abello facility in Denmark
The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).
QuVa buys New Jersey manufacturing plant citing access to regional markets
QuVa Pharma has agreed to buy a manufacturing facility in New Jersey, US at which it plans to compound sterile pharmaceutical products for hospitals.