Bluebird Confident Beti-Cel Will Fare Better In US Than Europe
The company built on its case for FDA approval with new beta-thalassemia data at ASH, but investor jitters linger after the pullout of Zynteglo from Europe amid reimbursement woes for the gene therapy.
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Broader Horizons For Advanced Biotech In 2022: New Targets, Settings For IO, Cell And Gene Therapy
US FDA’s user fee goal calendar for 2022 already contains 45 applications for novel agents featuring a wide array of biologics, from cell therapy in cancer and hematology to bispecifics and new immuno-oncology targets that could move the field beyond PD-1/L1.
Vertex’s 22% Sales Growth And Pipeline Gives Biotech Something To Smile About
In a gloomy start to the year for the biotech sector, Vertex’s strong showing in cystic fibrosis and promising pipeline could lift the mood.
Safety Concerns Hit Bluebird Sickle Cell Trial, Again
The FDA placed a partial hold on its clinical program for lovo-cel due to an adolescent patient experiencing anemia 18 months after treatment, raising uncertainty over filing plans.