The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research at FDA plan to take additional steps to increase transparency regarding CDER and CBER's review of the scientific information supporting the issuance of or revisions to an emergency use authorizations.
Agendia Inc. and Paige, are collaborating to co-development treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia's proprietary MammaPrint and BluePrint diagnostic tests for patients with breast cancer.
FDA has approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test Oct. 26 and Nov. 6 as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens.
FDA has issued a final guidance to increase diversity in clinical trials.
The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase translocation.
Lynparza (olaparib) has been approved in the European Union for the first-line maintenance treatment with bevacizumab of patients with homologous recombination deficient-positive advanced ovarian cancer.
Japan's Ministry of Health, Labor and Welfare has issued marketing authorization for Foundation for Biomedical Research and Innovation at Kobe to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan.
Merck and VelosBio Inc. have entered into a definitive agreement, where Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash.
The next-generation sequencing-based FoundationOne CDx test has received FDA approval as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase genes, NTRK1, NTRK2, and NTRK3, in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with Vitrakvi (larotrectinib).
FDA has approved expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic for a broad group of therapies in the treatment of non-small cell lung cancer.
