BIA Separations launches purification technology for AAV production
BIA Separations introduces technology able to remove host-cell DNA and proteins from AAV products, aiming to accelerate clinical development of gene therapies.
Archives for September 17, 2019
hyperCore site network completes virtual trial training program
hyperCore International is the first site network to receive the ‘Virtual Trial Capable’ certification after completing VirTrial’s recently launched training program.
Gottlieb on board to advance Aetion’s RWE work, guide platform development
Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.
Shimmer initiative looks to answer ‘critical questions’ about wearable use in clinical trials
Shimmer Research launches an initiative to develop a set of open-source algorithms and software tools for analyzing wearable sensor data – and, ultimately, standards that will be accepted by industry and regulators.
O2h to do ‘heavy lifting’ as part of synthetic chemistry collaboration with Cedilla
Cedilla Therapeutics and o2h Discovery have announced a multi full-time-equivalent (FTE) expansion to their synthetic chemistry collaboration.
Further NDMA contamination discovery prompts lawsuit
Both the FDA and EMA announce NDMA contamination of ranitidine medicines and a lawsuit is immediately filed against manufacturers for ‘concealing’ the carcinogen.
Merz completes construction of new plant and filling line
Merz announces that it has completed the construction of a new plant for its botulinum neurotoxin product and unveils a ‘robot-controlled’ filling line.