Drug Development
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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CEL-SCI Corporation, Jazz Pharmaceuticals, CARsgen and Ascentage Pharma presented clinical trial data at the American Society of Clinical Oncology 2022 Annual Meeting.
Sernova shared positive Phase I/II data from an ongoing clinical study of its implantable Cell Pouch device that showed evidence of in vivo active insulin production.
Results of a Phase II/III study showed that patients who were given Tafinlar plus Mekinist saw an overall response rate of 47% vs. 11% for those who received standard chemotherapy only.
Johnson & Johnson and Emergent BioSolutions are accusing each other of breaching their COVID-19 vaccine supply agreement.
The Phase II/III Aria Study was unsuccessful in achieving statistical significance on the primary endpoint or any secondary objectives, according to Praxis.
The combination of Opdivo plus Yervoy in addition to chemotherapy demonstrated additional benefits in patient populations who usually have poor prognoses.
Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
A combination study of CG Oncology’s oncolytic immunotherapy and a checkpoint inhibitor is showing promise.
Legend Biotech and J&J, Adicet Bio, Curis and Immutep present optimistic early and mid-stage results at ASCO.
Ibrance, a first-line treatment for ER+, HER2 - metastatic breast cancer, did not improve the overall survival rate in patients. Read on to know more.