Industry News

A Deep Dive On mRNA Vaccines

02/19/2021

Excerpt from the Article: February 11, 2021 | Messenger RNA (mRNA) vaccines were the focus of a symposium on COVID-19 vaccines held during last week’s COVID-19 and Cancer virtual meeting of the American Association for Cancer Research. To date, only two vaccines have received Emergency Use Authorization by the U.S. Food and Drug Administration and…

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Building a Biotech Program: H2i’s10 Point Plan Workshop

02/18/2021

Excerpt from the announcement: Take your first steps toward entrepreneurship with Building a Biotech Venture, a new program for regenerative medicine-focused trainees in labs at the University of Toronto (U of T) and its affiliated hospitals, offered in partnership with the Health Innovation Hub, a campus-linked accelerator at the Temerty Faculty of Medicine at U of T. In the H2i 10…

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Verily links with Janssen for at-home COVID-19 immune system study

02/18/2021

Excerpt from the Article: Verily is teaming up with Johnson & Johnson’s Janssen division to observe the body’s earliest immune responses to a coronavir12us infection, with people participating in the research from within their own homes. The study will be launched through Verily’s Project Baseline testing program and aims to collect biological information and real-world…

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Dexcom Launches Inaugural Venture Capital Fund

02/18/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–DexCom, Inc. (Nasdaq: DXCM), the global leader in continuous glucose monitoring for people with diabetes, today announced the launch of Dexcom Ventures. The inaugural fund will seek to identify and invest in opportunities to supplement growth in the core business and advance the development of adjacent technologies for…

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Trefoil Therapeutics Begins Second Phase 2 “STORM” Clinical Trial with Regenerative Treatment for Fuchs Endothelial Corneal Dystrophy

02/17/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Trefoil Therapeutics today announced it has begun a Phase 2 clinical trial of its engineered Fibroblast Growth Factor-1, TTHX1114, to evaluate its safety and efficacy as a regenerative treatment for patients with Fuchs Endothelial Corneal Dystrophy (FECD). The “STORM” study, the second clinical trial of TTHX1114, is designed…

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How to Handle a COVID-19 Vaccine-Related Adenopathy Seen on Breast MRI

02/17/2021

Excerpt from the Article: The Hospital of the University of Pennsylvania offers guidance – BI-RADS scoring and follow-up recommendations – for unilateral axillary lymphadenopathies seen on breast MRI in women who have received the vaccine. The baseline breast MRI of a 48-year-old woman who has the BRCA1 mutation, as well as a strong family history…

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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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