News & Updates

The FDA’s Digital Health Center Of Excellence: Why It Matters And What It Means To You

11/23/2020

Excerpt from the Article: Last month, the US Food and Drug Administration (FDA) launched the Digital Health Center of Excellence (DHCoE), bolstering the shift toward digital that the healthcare industry has already been embracing. Investment in digital health is at an all-time high. The market cap created from nine IPOs in 2019 from companies in…

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AVROBIO Announces New Positive Clinical Data and Preclinical Data, as Well as Expanded Leading Lysosomal Disorder Gene Therapy Pipeline

11/23/2020

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced positive new data across its clinical programs in Gaucher disease type 1, Fabry disease and cystinosis, further reinforcing the potential of ex vivo lentiviral…

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NANOBIOTIX Announces Positive New Pre-clinical Data Suggesting Radioenhancer NBTXR3 Could Have a Significant Impact in Immunotherapy

11/22/2020

Excerpt from the Press Release: PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–NANOBOTIX (Euronext: NANO – ISIN: FR0011341205 – the “Company”), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced positive new in vivo pre-clinical data from two (2) studies at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting. One…

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NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100™ for Critical COVID-19 with Respiratory Failure

11/21/2020

Excerpt from the Press Release: RADNOR, Pa. and GENEVA, Nov. 13, 2020 /PRNewswire/ — NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF,OTCBB:RLFTF) (“Relief”) announced that as of today, 150 patients (out of a targeted enrollment of 165) have been enrolled in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating respiratory failure in patients with Critical…

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SCOPE International US office celebrates 5th Anniversary

11/20/2020

Excerpt from the company announcement: “This summer, the US office of SCOPE International celebrated our 5th Anniversary. There are many words that can be used to describe the journey thus far, but ones that stick out include: Engaging, Challenging, Rewarding, Collaborative, and Family. A big thank you to our partners, clients and each of the…

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Ask Us Anything – Medical Devices and Diagnostics

11/19/2020

Yesterday, we held our fifth virtual networking meeting in our ongoing series called Ask us Anything In Clinical Research. For our fifth meeting we covered the topic of Medical Device and Diagnostic studies. Our guest for this meeting was Eric Filion, Vice President of Sales for LOK North America – Medical Device Regulatory experts. Thank…

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Hope Biosciences Stem Cell Research Foundation Selects Phlexglobal to Support Rapid, Compliant Investigational New Drug Application for COVID-19 Therapy

11/19/2020

Excerpt from the Press Release: Phlexglobal, a leading innovative technology and services provider for the life sciences industry, today announces that Hope Biosciences Stem Cell Research Foundation has selected Phlexglobal’s advanced SaaS solution, PhlexSubmission, to enhance the efficiency and quality of its eCTD submissions process. As an organization dedicated to advancing research through innovative protocols…

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Werewolf Therapeutics Appoints Dr. Randi Isaacs as Chief Medical Officer

11/18/2020

Excerpt from the Press Release: CAMBRIDGE, Mass., Nov. 9, 2020 /PRNewswire/ — Werewolf Therapeutics, Inc., an oncology biotherapeutics company developing next-generation, transformative cancer therapeutics, today announced the appointment of Randi Isaacs, M.D., as Chief Medical Officer. Dr. Isaacs brings to the Werewolf team more than 20 years’ experience as a hematologist and oncologist driving clinical…

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Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2

11/17/2020

Excerpt from the Press Release: SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it is filing an investigational new drug application (IND) for intravenous (IV) COVI-AMG (STI-2020) to treat COVID-19 patients with mild symptoms and to evaluate safety and pharmacokinetics in healthy volunteers. Sorrento has previously…

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Stanford develops CRISPR ‘lab on a chip’ for detecting COVID-19

11/16/2020

Excerpt from the Article: Researchers at Stanford University have developed a CRISPR-based “lab on a chip” to detect COVID-19, and are working with automakers at Ford to develop their prototype into a market-ready product. This could provide an automated, hand-held device designed to deliver a coronavirus test result anywhere within 30 minutes. In a study…

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