Business, Policy & Funding
Breaking news on precision medicine business, policy & funding.
Precigen to Begin Phase II Study of PRGN-2009, Keytruda in HPV-Positive Cervical Cancer
The FDA granted the firm permission to study the off-the-shelf T-cell vaccine with the immune checkpoint inhibitor in pretreated metastatic HPV-positive cervical cancer patients.
Yuhan Licenses HER2 Inhibitor From J INTS Bio in $325M Deal
J INTS Bio is evaluating JIN-A04 in preclinical studies as a treatment for HER2 exon 20-mutant non-small cell lung cancer.
Anew Medical Expecting to Access $54M Following SPAC Merger
The company is hoping the capital will help it advance a pipeline of gene therapies for various neurodegenerative diseases.
FDA Reviewing Iovance's BLA for Melanoma TIL Therapy; Decision Expected in November
Iovance said the FDA is reviewing its BLA, and if successful, lifileucel could be the first autologous cell therapy approved for solid cancer.
FDA Accepts BMS's NDA for Repotrectinib in ROS1-Positive NSCLC
The agency is reviewing data from the Phase II TRIDENT trial and expects to decide whether to approve the drug by Nov. 27.