GBC Blog

Researchers are hoping to understand whether the microbes in our guts have a role in the disorder. Before Ethan Loyola reached his first birthday, it was clear that something was wrong with his gut. As a baby, he had been given several courses of antibiotics to treat severe ear infections, after which he experienced foul-smelling,…

Every day, millions of Covid-19 tests are performed around the world. Because of the pandemic, everyone is aware of the importance of diagnostic testing. But, as I pointed out earlier, diagnostic tests are necessary for a wide range of conditions that affect all of us, not just pandemic threats. Good clinical care begins with the first…

All crises are not equal, but they all need to be recognised, says Robert Hewitt Robert Hewitt is the founder of Biosample Hub, a new platform that connects biotech companies looking for samples with biobanks that have ethically sourced samples available A dictionary definition of a crisis is a time of great difficulty or danger…

On Friday, September 17, 2021, leadership from the National Cancer Institute (NCI), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) signed a Memorandum of Understanding (MOU) to support solutions for early cancer detection and diagnosis to improve patient outcomes, quality of life, and reduce health disparities among medically underserved, geographically isolated,…

After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have…

The contract research sector has seen major buyouts and a series of bolt-on deals, and clinical research specialist WCG is the latest to get in on the act as it heads to Wall Street. The nine-year old Princeton, New Jersey-based company, which offers trial help to biopharmas and CROs, made around $500 million last year…

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…