Industry news that matters to you.  Learn more

Astellas, Daiichi Sankyo, and Takeda Announce Research Collaboration on Establishing Biomarker Database on Healthy Adults

Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka; Headquarters: Tokyo; TSE: 4503; “Astellas”), Daiichi Sankyo Company, Limited (President and CEO: Joji Nakayama; Headquarters: Tokyo; TSE: 4568; “Daiichi Sankyo”), and Takeda Pharmaceutical Company Limited (President and CEO: Christophe Weber; Headquarters: Osaka; TSE: 4502; “Takeda”) recently announced that they have entered into a joint research agreement. It is an agreement to comprehensively acquire and analyze fundamental biomarker*1 data on healthy adult volunteers in order to optimize and accelerate the development of innovative medicines.

NeuroVigil Announces New Brain Research Initiatives

NeuroVigil, Inc. recently announced that is has formed a multi-year alliance with a large Pharmaceutical Company, which will use NeuroVigil’s portable non-invasive iBrainTM. NeuroVigil also announced that it has separately created an alliance with the University of Basel, one of Europe’s leading biomedical research universities, to specifically tackle Rett Syndrome, a lethal neurodevelopmental disorder that affects girls almost exclusively.

US FDA Extends License of the GVK BIO Biomarker Database

GVK Biosciences (GVK BIO) recently announced that it is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (US FDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the US FDA in its Biomarker Qualification Process.

The GOBIOM database is a comprehensive compilation of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GOBIOM contains information on 20,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers, along with multiple data points comprising experimental, analytical, clinical and statistical data with their qualifications under different medical interventions.

Sreeni Devidas, Vice President, Sales & Marketing, Informatics, said, “The collaboration with the US FDA has helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database in a manner that has facilitated the user to make a comparative analysis between the biomarkers of their interest. We look forward to continue working and collaborating with the FDA with a view to enhancing the utility of the product further.”

Source: Business Wire

BiomarkerBase, The Clinical Biomarker Database, Now Includes Biomarkers in Clinical Trials & FDA-Approved IVD Tests

BiomarkerBase™ (http://www.biomarkerbase.com) has recently been updated to include every biomarker listed in a phase 3 or 4 clinical drug trial. This addition of over 170 new clinical biomarkers adds to the hundreds of existing biomarkers sourced from drug labels and commercialized diagnostic tests.

Amplion Research Launches BiomarkerBase, The Clinical Biomarker Database

BiomarkerBase™, the first available database of every biomarker currently in active clinical use, was launched recently at http://www.biomarkerbase.com.