Industry News

EU regulators expand use of remote source data verification in clinical trials

02/16/2021

Excerpt from the Article: The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials. Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few…

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In a Time of COVID, Dealmakers Take a Shine to Diagnostics and Vaccines

02/16/2021

Excerpt from the Article: If you had an inkling that more money went to vaccine and diagnostic companies in 2020, you were right.  Diagnostics and vaccines have long been the red-headed stepchildren of life sciences investments. Detecting and treating life threatening diseases is the responsible thing to do when the world is threatened with a…

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Best Practices For Implementing Decentralized Clinical Trials

02/16/2021

Excerpt from the Article: Today’s new COVID realities mean changes in how clinical trials are administered. Here’s what to consider in adopting decentralized clinical trials. As the COVID-19 pandemic turned the world upside down, clinical trials have been deeply impacted, with thousands of trials either canceled or delayed — all during a time in which…

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Cue Health’s Connected Point-of-Care COVID-19 Test Demonstrates 97.8% Agreement When Compared to Central Lab PCR Testing in an Independent Clinical Validation Study

02/15/2021

Excerpt from the Press Release: SAN DIEGO, Feb. 11, 2021 /PRNewswire/ — Cue Health Inc. (Cue) announced today the results of an independent clinical validation study conducted by Mayo Clinic Laboratories evaluating the accuracy of Cue’s COVID-19 Test in the point-of-care setting against the centralized lab PCR testing model. The study, which was published in…

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Evaluating Imaging Technology Investments Requires New Definitions

02/15/2021

Excerpt from the Article: Is it possible for organizations to strike the right balance between technology adoption and controlling cost to meet current needs? Even before COVID-19 swept the globe, the balancing act of managing costs while maintaining value was at the forefront of imaging technology purchasing decisions. While the roller coaster effect of the…

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PET Imaging Reveals Which Breast Cancer Patients Won’t Respond to Hormone Therapy

02/14/2021

Excerpt from the Article: Hormone therapy is only effective in roughly half of estrogen receptor-positive cancers. Being able to identify patients that will not respond could save valuable treatment time. The answer to whether hormone replacement therapy will work for a woman with breast cancer likely comes down to whether her estrogen receptors are working…

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SARS-CoV-2 Infection Prevented and Treated in Human Lung Tissue Model

02/13/2021

Excerpt from the Article: Given the steady numbers of new COVID-19 cases, the appearance of new variants, and the considerable time that vaccinations will take to reach target levels needed for herd immunity, the development of treatments and useful therapeutics remains a top priority. In particular, treatments and preventive approaches that can be widely and…

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UHN-led study shows antiviral drug speeds up clearance of COVID-19

02/12/2021

Excerpt from the Article: A clinical study led by Dr. Jordan Feld, a liver specialist at UHN’s Toronto Centre for Liver Disease, showed an experimental antiviral drug can significantly speed up recovery for COVID-19 outpatients – patients who do not need to be hospitalized. This could become an important intervention to treat infected patients and…

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Experimental stem cell therapy a potential weapon against COVID-19

02/12/2021

Excerpt from the Article: When the COVID-19 pandemic hit, researchers in Canada and around the world moved quickly to pivot their research and help with the development of new treatments and vaccines.  At The Ottawa Hospital, this resulted in more than 60 different research projects and trials, including an innovative clinical trial of mesenchymal stem…

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Vaxart Announces Positive Preliminary Data from Phase 1 Clinical Trial Evaluating Its Oral COVID-19 Tablet Vaccine Candidate

02/12/2021

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Feb. 03, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, today announced preliminary data from its Phase 1 study of VXA-CoV2-1 showing that its oral COVID-19 tablet vaccine candidate was generally well-tolerated, and immunogenic as measured by…

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