Recent Tech Transfer Deals (06/11)
This article was originally published in Start Up
Our monthly update on technology transfer deals--licensing agreements between companies and universities or other research institutions--in the fields of life sciences, including pharmaceuticals, medical devices, in vitro diagnostics and research/analytical instrumentation and reagents.
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More than 9,000 of the kits made by Aligned Medical Solutions have been recalled because they include a prefilled saline syringe that was the subject of a high-risk class I recall.
Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”
The US FDA has objected to studies conducted by India-based contract research organizations Panexcell Clinical Lab and Synchron Research Services, because of data integrity concerns. The FDA has warned pharmaceutical companies sponsoring drug application approvals, that data generated by Panexcell and Synchron will be “unacceptable.”