Major FDA approvals for Vertex/CRISPR; bluebird gets black box warning and price scrutiny

This week, we discuss the two major FDA approvals for sickle cell from Vertex/CRISPR and bluebird bio; Axcella and the future of long-covid treatments, Vanda’s $100m purchase and AI regulatory developments in Europe.

That was Week with a capital W. Two ⁠major FDA approvals⁠ for sickle cell came through on Friday - Casgevy, the first-ever CRISPR-based gene editing therapy from Vertex and CRISPR Therapeutics, and ⁠bluebird bio’s Lyfgenia⁠, which comes with a hefty price tag and a black box warning.

⁠Axcella⁠ announced its closure; what does the future of long-covid treatments look like, especially as attention shifts to different markets like ADCs and ⁠neurological⁠ treatments?

Also discussed - ⁠Vanda⁠ drops $100m on rights to MS drug Ponvory, AI regulatory developments in Europe.

BioSpace’s Lori Ellis, Greg Slabodkin and Tyler Patchen discuss.

Lori Ellis is the head of insights at BioSpace, providing industry analysis as well as paid custom content for BioSpace clients. Her current focus is on the ever-evolving impact of technology on the pharmaceutical industry. You can reach her at lori.ellis@biospace.com. Follow her on LinkedIn.

Greg Slabodkin is the News Editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.    

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.


> Listen on Spotify

> Listen on Apple podcasts

> Listen on Amazon Music

> Listen on iHeart

Lori Ellis is the Head of Insights at BioSpace. She analyzes and comments on industry trends for BioSpace and clients. Her current focus is on the ever-evolving impact of technology on the pharmaceutical industry. You can reach her at lori.ellis@biospace.com. Follow her on LinkedIn.
Greg is a seasoned editor/writer who has covered the healthcare, life sciences and medical device industries for several tech trade publications. Follow him on LinkedIn.
Tyler Patchen is a freelance writer based in Alabama. He was formerly staff writer at BioSpace. You can reach him at tpatchen94@gmail.com.
MORE ON THIS TOPIC