GBC Blog

The rumors were true: Whispers grew this year that Parexel, owned for the past four years by Pamplona Capital, was seeking a sale or an IPO. Today, the whispers stopped as the CRO loudly declared it is being bought out for $8.5 billion. The suitors and soon-to-be owners are the Swedish investment firm EQT Private Equity and the…

Surveys show patients, sponsors and CROs in Chinasee the benefits of virtual and hybrid trials. Concernsremain around regulatory gaps, digital data collectionand study logistics. View White PaperBy MAGGIE MA, Director of Clinical Operations – IQVIA, China

Posted 02 June 2021 | By Joanne S. Eglovitch  The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years. The device was developed by Cognoa, a company based in Palo Alto, CA, that…

NEW YORK, Feb. 22, 2021 /PRNewswire/ — Mirimus, Inc., a leader in conducting high-volume, high-quality PCR testing, today announced the publication of a scientific paper, titled, “Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections in K-12 Schools and Universities,” available for preprint on MedRxiv as it undergoes scientific peer review for potential publication. The paper…

January 13, 2021The National Institutes of Health has awarded three new contracts totaling $36.7 million for the development of new COVID-19 diagnostic testing technologies and production of specimen collection kits and swabs. The Rapid Acceleration of Diagnostics (RADx) initiative has advanced the scale-up of 25 testing projects since July 2020, which now include lab-based, point-of-care,…

The U.S. Food and Drug Administration on Tuesday authorized a Covid-19 test that can be administered and processed at home, the first such test allowed to be sold over-the-counter at drugstores or other retail locations without a prescription. The antigen test, made by Ellume USA LLC, is a single-use, disposable test that searches for pieces…

LA VISTA, Neb., Sept. 11, 2020 /PRNewswire/ — Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood collection tube to be cleared for use…

September 10, 2020 – Broad Institute of MIT and Harvard Summary: Scientists have completed a wide-ranging set of studies documenting how small changes in DNA sequence can impact gene expression across more than four dozen tissues in the human body. These studies, released in a set of 15 articles, constitute the most comprehensive catalog to…

Many months into the COVID-19 pandemic, the coronavirus is still spreading uncontrolled through the U.S. Public health authorities including the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) tell us to remain six feet apart, wash our hands, disinfect frequently touched surfaces, and wear masks. But compliance with these measures—especially masks—is mixed, and…

BBC.Com 19-July-2020. While the latest research suggests that antibodies against Covid-19 could be lost in just three months, a new hope has appeared on the horizon: the enigmatic T cell.T The clues have been mounting for a while. First, scientists discovered patients who had recovered from infection with Covid-19, but mysteriously didn’t have any antibodies against…