Thermo Fisher Scientific’s clinical sequencing business and AstraZeneca announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca’s expanding portfolio of targeted therapies.
The U.S. Food and Drug Administration granted accelerated approval of Janssen’s Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved FoundationOne Liquid CDx, a new pan-tumor liquid biopsy test that is indicated for use as a companion diagnostic for four FDA-approved precision therapies.
Thermo Fisher Scientific and Daiichi Sankyo have partnered to co-develop a companion diagnostic device for patients who have non-small cell lung cancer (NSCLC).
Thermo Fisher Scientific inked a deal with Janssen Biotech, part of Johnson & Johnson, to co-develop a companion diagnostic for cancer. The diagnostic test will support global clinical trial enrollment.
Illumina Inc. and Qiagen N.V. announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.
Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.
A recent report written by SVB Leerink analysts that looked at eight companies and their research-and-development portfolios found that in the past five years, they progressed only 24 percent of their new molecular entities to approval.
Five Prime Therapeutics announced a collaboration with Roche to develop immunohistochemistry companion diagnostic assays for use with the clinical-stage biotechnology company’s first-in-class investigational drug candidates: the anti-FGFR2b antibody bemarituzumab (also known as FPA144) and the a B7-H4 antibody FPA150.
Foundation Medicine Inc. announced a collaboration with Merck & Co. to develop companion diagnostic tests for use with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability high or mismatch repair deficient solid tumors.