News & Updates

Providence researchers request FDA approval for COVID-19 vaccine clinical trial

04/08/2020

Excerpt from the article: “PORTLAND, Ore. — Providence researchers in Portland submitted a request to the Food and Drug Administration for the first clinical trial of a viral COVID-19 vaccine. The Earl A. Chiles Research Institute (EACRI) at Providence’s Robert W. Franz Cancer Center is using its knowledge of cancer vaccine immunotherapy to develop a…

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Canada begins clinical trial of experimental COVID-19 treatment using plasma from recovered individuals

04/07/2020

Excerpt from the article: “A team of blood transfusion experts from across Canada is planning the world’s largest clinical trial of a potential treatment for COVID-19. The study, which will involve 1,000 patients from across the country, will include at least 40 Canadian hospitals, and is being overseen by doctors from the University of Montreal,…

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First cell treatment to fight the coronavirus awaits FDA approval for clinical trial

04/07/2020

Excerpt from the article: “The Food and Drug Administration is expected to approve the first of a whole new type of weapon to be tested in the international struggle against COVID-19 as the disease continues to sweep across the globe. New Jersey-based therapeutics company Celularity announced that its cancer treatment, CYNK-001, is awaiting “investigational new…

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How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials

04/06/2020

Meaghan Powers, lead consultant, Halloran Consulting Group penned an excellent article on integrating Quality Management with RBM Meaghan tackles a number topics in the 3 Key Steps To Successful Execution. First, a risk assessment must be conducted both pre-study and ongoing during the trial. Second, a well-articulated study protocol should be developed based on factors…

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Color is launching a high-capacity COVID-19 testing lab and will open-source its design and protocols

04/04/2020

Excerpt from the article: “Genomics health technology startup Color is doing its part to address the global COVID-19 pandemic, and has detailed the steps it’s taking to support expansion of testing efforts in a new blog post and letter from CEO Othman Laraki on Tuesday. The efforts include development of a high-throughput lab that can…

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Crucial test to identify those who have recovered from COVID-19 and have active immunity

04/04/2020

Excerpt from the article: “A test that can determine if a patient had been infected and recovered from COVID-19 is being developed at Mayo Clinic Laboratories. The test will detect the presence of antibodies specific to SARS-CoV-2, the virus that causes COVID-19. Antibodies are produced by a person’s immune system, and are critical for control…

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Researchers to study if startup’s wrist-worn wearable can detect early COVID-19 respiratory issues

04/03/2020

Excerpt from the article: “It’s highly unlikely that the current coronavirus crisis will be neatly and fully “solved” by any one endeavor or solution, which makes new studies like one involving startup WHOOP’s wrist-worn fitness and health tracking wearable all the more important. The study, conducted by the Central Queensland University Australia (CQUniversity), in partnership…

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FDA authorizes Bodysphere 2-minute COVID-19 test

04/03/2020

Excerpt from the article: “Bodysphere announced today that it has begun distributing its 2-minute testing kit for diagnosing COVID-19 after receiving FDA emergency use authorization (EUA). The Los Angeles-based company’s two-minute testing kit uses antibodies in blood to test for current or past infection with a 91% clinical specificity rate and a 99% clinical sensitivity…

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The impact of COVID-19 on biotech/pharma service providers.

04/02/2020

The Team at Zymewire took advantage of their unique position in the life sciences space to survey their client base regarding the impact of COVID-19 on their operations and business outlook. TrialStat had an opportunity to participate in the survey and the results are out. It’s resoundingly clear that the pandemic is impacting all aspects…

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AI tool predicts which coronavirus patients get deadly ‘wet lung’

04/01/2020

Researchers in the United States and China reported on Monday that they developed an artificial intelligence tool that is able to accurately predict which newly infected patients with the coronavirus go on to develop severe lung disease. Once deployed, the algorithm could assist doctors in making choices about where to prioritise care in resource-stretched healthcare…

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