News & Analysis on Clinical Trial Services & Contract Research And Development
UPDATED: UCART19
Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
Q&A with CEO and CMO
AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS).
Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA.
The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.
A pool of contractors will compete for task orders as part of the NIAID's preclinical drug development services contract to develop therapeutics for a range of global infectious diseases.
CROS NT has opened a new office in Bangalore, India as it looks to expand its clinical, regulatory, and data services lines to meet client demand.
Evotec AG and MaRS Innovation have launched Fibrocor Therapeutics LP – a new company which will focus on developing first-in-class therapeutics targeting fibrotic diseases.