STAT+: Makary, Prasad outline pathway for bespoke gene therapy

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Morning. Today, we learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline, and more. 

The need-to-know this morning

  • Day One Pharmaceuticals is acquiring Mersana Therapeutics in a deal valued at $129 million, and up to $285 million if certain post-close milestones are met. Day One markets a treatment for pediatric brain tumors, while Mersana is developing antibody-drug conjugates for cancer. 

FDA outlines pathway for bespoke gene editing

FDA Commissioner Marty Makary and biologics chief Vinay Prasad have sketched out the agency’s first real blueprint for approving personalized gene-editing therapies, STAT’s Jason Mast reports. It’s a shift that could transform last year’s one-off miracle for “Baby KJ” into a scalable model for ultra-rare diseases.

Continue to STAT+ to read the full story…

​STAT Pharma: The science and business of new drug development

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