Caraco's Detroit plant rehab timeline extended

Caraco says it's unlikely to resume manufacturing at its Detroit facility before April, as it had estimated earlier. Following a review with its GMP consultants on the remediation steps completed since it entered into a consent decree with the FDA in September 2009, and those still pending, the generics maker has revised its restart estimate. Remediation continues, the company says, but it can't predict when manufacturing and distribution operations will resume. Caraco release  


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

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

Learn how 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.