R&D accepts new assignment

Caraco limps along following its September agreement to an FDA consent decree.

After June's product seizures in Michigan, prompted by repeated cGMP violations, the generics maker is struggling to make the fixes needed before regulators will give it the green light to resume manufacturing ops. The company says it will attempt to have some of the seized inventory released, including $8 million worth raw material, according to a Reuters report.

The inadvertent good news: The company expects a decline in R&D costs as it puts a part of that team to work on efforts to regain compliance and technical validations. Not good: The company said it instituted indefinite layoffs of about 430 employees in two phases. In June, it had terminated half its workforce.

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Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.