Gilead’s continued investment in cell therapy manufacturing capabilities, at a time when sales at the nascent business unit are flatlining, was called into question by investors.
US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
The pace of development in the industry sees greater demand for a trained workforce, which is leading away from ‘classroom’ to technology-assisted working environments, says training lead at Zenith.
NIH and the Gates Foundation have set themselves the goal of bringing curative gene therapies to clinical trials in the US and Africa in the next seven to 10 years.
Early dialogue with patients is ‘critical’ to design efficient clinical development programs for ATMPs and avoid ‘data gaps’, an executive from ARM says.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
Alkermes to work collaboratively with the Fred Hutchinson Cancer Research Center on the clinical development of a drug candidate as a combination treatment alongside Keytruda.
An expansion to BIA Separations' Cornerstone set of processing services for viral vector development adds the use of kryptonase and CIMmultus chromatography device.
