FDA blasts Lonza facility in Form 483 that derailed Bristol Myers' plan of liso-cel nod by 2020

FDA blasts Lonza facility in Form 483 that derailed Bristol Myers' plan of liso-cel nod by 2020

Source: 
Fierce Pharma
snippet: 

A manufacturing shortfall likely cost Bristol Myers Squibb the chance of an FDA approval for CAR-T therapy liso-cel by the end of 2020—and sent a potential $9-apiece Celgene deal sweetener into the trash can. Investors looking for details of the expensive misstep now have the answers.