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BRAINBox Solutions Announces First Close in $23 Million in Series A Financing to Support Development and Pivotal Clinical Trial of ‘Breakthrough’ Concussion Diagnostic/Prognostic Test

By News Archive

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Scott Gazelle, MD, PhD, MPH, FACR Appointed to Board of Directors and Damon Kuehl, MD, FACEP Joins Scientific Advisory Board

RICHMOND, Va. (December 8, 2020) ‐ BRAINBox Solutions today announced the initial closing on a $23 million Series A financing to support the clinical development of the company’s BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion).  BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate.  

“The BRAINBox TBI test has enormous potential to significantly improve patient care as an aid to objectively diagnosing and managing the treatment of concussion patients,” said Marc Goldberg, BioVentures Investors Co-Founder and Managing Partner. “The company has made great progress, particularly in this challenging COVID-19 environment, in advancing the development of the BRAINBox TBI testing system, including laying the groundwork for the pivotal, HeadSMART II clinical trial and securing ‘Breakthrough Designation’ from the FDA.”  He noted there are more than five million patients evaluated in emergency rooms annually for mild TBI as well as additional patients in urgent care settings.

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QIAGEN to launch QuantiFERON SARS-CoV-2 for research into causes, spread and control of COVID-19 through T-cell response

By News Archive

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Hilden, Germany and Germantown, Maryland, December 7, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today the launch of its QuantiFERON SARS-CoV-2 RUO solution that can detect T-cell responses of the human immune system to the pathogen that causes COVID-19, which could help researchers find out more about immunity levels and disease progression.

Studies suggest that T-cell response to SARS-CoV-2 declines much more slowly than antibody response, which presents several benefits to researchers who want to push beyond the existing detection of active infections to screen for potential courses of the illness and long-term immune responses to it. QIAGEN’s QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution  could be a valuable tool in this research.

 

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Doudna Talks Nobel Success and Women in Science

By News Archive

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Jennifer Doudna PhD, the UC Berkeley biochemist who shared the 2020 Nobel Prize in Chemistry with Emmanuelle Charpentier PhD, was the recent guest of honor for the final episode in the “Women in Science” web series, co-organized by GEN and the Rosalind Franklin Society. 

In 2012, the Doudna and Charpentier labs teamed up to publish a landmark paper in which they adapted the CRISPR microbial anti-viral defense system to create a programmable method for genome targeting. The work laid the foundation for CRISPR genome editing, which has become not only a ubiquitous research tool but also applied in clinical gene therapy, diagnostics, agriculture, and many other applications.

Image: https://www.genengnews.com

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434th Edition, December 1, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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December 1, 2020












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Novavax Announces COVID-19 Vaccine Clinical Development Progress | Novavax Inc. – IR Site

GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

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Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 Minutes · BioBuzz

Rockville, Maryland’s Maxim Biomedical (MaximBio) is on the cusp of bringing 3 million of its new and effective point-of-care COVID-19 tests to the fight against the coronavirus pandemic in early 2021, with a scale up to 15 million tests per month expected by Q2 2021. 

The company’s brand new point-of-care (POC), ready out-of-the-box antigen test is based on a Lateral Flow Assay technology (LFA) that produces visually interpreted results within 15 minutes. 

 

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Sisu’s Life Saving Hemafuse Device Introduced in Five Frontier Hospitals of Kenya – APO Group – Africa Newsroom / Press release

BALTIMORE, United States of America, October 29, 2020/APO Group/ — Sisu Global’s (SisuGlobal.health) flagship medical device is Hemafuse, a surgical autotransfusion device that is revolutionizing blood access across Africa. There is a global shortage of 100 millions units of donor blood worldwide, and only 40% of the demand for blood transfusions is met across Africa. The COVID-19 pandemic has dramatically worsened the global blood shortage as blood drives and large gatherings have been cancelled. Autotransfusion is the process of salvaging and retransfusing the patient’s own blood in cases of internal bleeding. Studies show that autotransfusion reduces a patient’s recovery time and risk of infection and removes the potential for rejection when compared to donor blood. Notably, autotransfusion is viable for cases of ruptured ectopic pregnancy. Other viable cases include blunt trauma, traffic accidents, and cardiac and orthopedic surgeries.

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AstraZeneca’s COVID-19 vaccine, up to 90% effective in late-stage trials, is being manufactured in Baltimore – Baltimore Sun

Late-stage trials showed that AstraZeneca’s coronavirus vaccine, which is being manufactured for the United States in Baltimore, was up to 90% effective, the English pharmaceutical company said Monday.

AstraZeneca’s vaccine candidate gives public health officials hope they may soon have access to a vaccine that is cheaper and easier to distribute than those of some of its rivals.

Even though the vaccine still needs regulatory approval, it’s already being made at Emergent BioSolutions’ plant in East Baltimore. The Gaithersburg-based contract drug manufacturer was named AstraZeneca’s U.S. manufacturing partner in June. The partnership was expanded in July and is now valued at $261 million.

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Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December Nasdaq:ALT

GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. AdCOVID is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract.

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Dr. Carol Nacy, CEO of Sequella Incorporated, joins BioTalk to discuss her career, the evolution of their science, and vision for the future.

Listen now via Apple https://apple.co/374aOFI, Google https://bit.ly/3pTGqqj, Spotify https://bit.ly/3nIl7WO, and TuneIn https://bit.ly/3nIl7WO

Dr. Nacy co-founded our Sequella in 1997 and has served as our CEO and Chairman of the Board since 1999. Prior to Sequella, Dr. Nacy served during 1997 and 1998 as Chief Scientific Officer (CSO) for Anergen, Inc., a California company acquired by Corixa Corporation in December 1998. From 1993 through 1997, Dr. Nacy was Executive Vice President and CSO at EntreMed, Inc. and participated in its successful initial public offering in June 1996. Previously, Dr. Nacy was Career Scientist (GS-15) at the Walter Reed Army Institute of Research, Washington, DC. Dr. Nacy currently serves on the board of directors of companies and non-profit agencies.

Click here for the Transcript

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Johns Hopkins study shows ‘magic mushrooms’ may be effective in treating major depression – Baltimore Business Journal

Four weeks after receiving monitored doses of psilocybin, researchers reported more than half of the study’s 24 participants had achieved remission from their depression.

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novavax logo

Novavax Announces COVID-19 Vaccine Clinical Development Progress | Novavax Inc. – IR Site

By News Archive

novavax logo

GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

“Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”

 

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AstraZeneca Logo

AstraZeneca’s COVID-19 vaccine, up to 90% effective in late-stage trials, is being manufactured in Baltimore – Baltimore Sun

By News Archive

AstraZeneca Logo

Late-stage trials showed that AstraZeneca’s coronavirus vaccine, which is being manufactured for the United States in Baltimore, was up to 90% effective, the English pharmaceutical company said Monday.

AstraZeneca’s vaccine candidate gives public health officials hope they may soon have access to a vaccine that is cheaper and easier to distribute than those of some of its rivals.

Even though the vaccine still needs regulatory approval, it’s already being made at Emergent BioSolutions’ plant in East Baltimore. The Gaithersburg-based contract drug manufacturer was named AstraZeneca’s U.S. manufacturing partner in June. The partnership was expanded in July and is now valued at $261 million.

 

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