BioMarin All Set For Hemophilia Gene Therapy Approval, But Is It Overestimating Demand?
Gearing Up For August Approval
Executive Summary
Analysts forecast a slow climb towards peak sales of $2bn – but competitors could erode that figure.
You may also be interested in...
Not Such A Sure Thing: FDA Knocks Back BioMarin’s Roctavian
BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.
Not Such A Sure Thing: FDA Knocks Back BioMarin’s Roctavian
BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.
August User Fee Calendar Features Gene Therapy, Analgesics, And Of Course Oncology
Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.