Office of Inspector General, U.S. Department of Health and Human Services

Genascence to Present Full Data from Phase 1 Clinical Trial on GNSC-001, Company's Lead Program in Osteoarthritis, at European Society of Gene & Cell Therapy 30th Annual Congress

Retrieved on: 
Tuesday, October 24, 2023

Study findings noted elevated IL-1Ra expression in synovial fluid and an encouraging trend in symptomatic improvement.

Key Points: 
  • Study findings noted elevated IL-1Ra expression in synovial fluid and an encouraging trend in symptomatic improvement.
  • These data will be delivered in a poster presentation at the European American Society of Gene & Cell Therapy's (ESGCT) 30th Annual Congress being held October 24-27, 2023, in Brussels, Belgium.
  • Clinical trial participants developed various degrees of anti-AAV neutralizing antibodies after injection of GNSC-001, but no capsid targeted T-cell response was detected.
  • The study was supported by funding from the U.S. Department of Defense Peer Reviewed Medical Research Program (PRMRP).

FDA Roundup: October 20, 2023

Retrieved on: 
Friday, October 20, 2023

ADUFA V and AGDUFA IV reauthorize the FDA to collect user fees through FY 2028.

Key Points: 
  • ADUFA V and AGDUFA IV reauthorize the FDA to collect user fees through FY 2028.
  • On Thursday, the FDA authorized an extension for the shelf life of Gohibic (vilobelimab) for specific lots, from 24 months to 30 months.
  • Additional information about the use of Gohibic can be found in the FDA statement describing the authorization for this product.
  • On Thursday, the FDA removed certain ventilation-related products (product codes: CBK and NOU) from the medical device shortage list .

Mays Cancer Center: Targeting certain molecular interactions could yield new strategies for treating prostate cancer

Retrieved on: 
Friday, October 20, 2023

SAN ANTONIO, Oct. 20, 2023 /PRNewswire-PRWeb/ -- Research led by Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has discovered that altering certain molecular interactions could yield new strategies for treating prostate cancer and related diseases.

Key Points: 
  • SAN ANTONIO, Oct. 20, 2023 /PRNewswire-PRWeb/ -- Research led by Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has discovered that altering certain molecular interactions could yield new strategies for treating prostate cancer and related diseases.
  • "Our results provide molecular insights for potential therapeutic strategies to treat prostate cancer and other AR-involved diseases by targeting AR multivalent interactions," said Zhijie "Jason" Liu, PhD, associate professor and CPRIT Scholar in Cancer Research with Mays Cancer Center and the Institute of Biotechnology of the Department of Molecular Medicine at UT Health San Antonio.
  • The Mays Cancer Center at UT Health San Antonio is one of only four National Cancer Institute-designated Cancer Centers in Texas.
  • The Mays Cancer Center provides leading-edge cancer care, propels innovative cancer research and educates the next generation of leaders to end cancer in South Texas.

BrainCheck Appoints Jennifer Cobb as Vice President of Partnerships

Retrieved on: 
Thursday, October 19, 2023

AUSTIN, Texas, Oct. 19, 2023 /PRNewswire/ -- BrainCheck, Inc. today announced the appointment of Jennifer Cobb as Vice President of Partnerships. In this role, Ms. Cobb will spearhead BrainCheck's efforts to establish strategic alliances with value-based care organizations, strengthening the company's commitment to improving comprehensive cognitive care. The announcement follows several recent pivotal developments in cognitive health, including the FDA approval of a new treatment for early Alzheimer's disease and the Centers for Medicare & Medicaid Services (CMS) release of new first-in-kind payment models and amended policies that support early diagnosis and caregiving for patients and their families.

Key Points: 
  • Accomplished leader to establish strategic alliances with value-based care organizations, strengthening the company's commitment to improving comprehensive cognitive care
    AUSTIN, Texas, Oct. 19, 2023 /PRNewswire/ -- BrainCheck, Inc. today announced the appointment of Jennifer Cobb as Vice President of Partnerships.
  • In this role, Ms. Cobb will spearhead BrainCheck's efforts to establish strategic alliances with value-based care organizations, strengthening the company's commitment to improving comprehensive cognitive care.
  • "Value-based care is at the forefront of healthcare innovation, and BrainCheck recognizes the importance of forging partnerships that align with this transformative approach.
  • "I am thrilled to join the accomplished team at BrainCheck and contribute to the company's mission of revolutionizing cognitive healthcare at a broader scale," said Ms. Cobb.

APCI to Feds: Stop Further Healthcare Vertical Integration in Optum-Amedisys Deal

Retrieved on: 
Thursday, October 19, 2023

The acquisition represents a further descent into an already vertically integrated healthcare supply chain.

Key Points: 
  • The acquisition represents a further descent into an already vertically integrated healthcare supply chain.
  • "APCI has been one of the loudest and most consistent voices in opposing further vertical and horizontal integration by large insurers and their affiliated PBMs," said APCI CEO Tim Hamrick.
  • "Community pharmacists have seen first-hand what vertical integration has done in pharmacy and the burden it has caused patients.
  • APCI is committed to advocating on behalf of patients and the community pharmacies that serve them against further large insurer/PBM integration before agencies, U.S. Congress, and in the states."

U.S. Department of Justice Awards Veritone Sole-Contractor Blanket Purchase Agreement at $15 Million

Retrieved on: 
Tuesday, October 17, 2023

(NASDAQ: VERI), a leader in enterprise AI software and services, today announced it has been selected by the U.S. Department of Justice (DOJ) for a $15 million Blanket Purchase Agreement, allowing all DOJ agencies to easily purchase Veritone software and services.

Key Points: 
  • (NASDAQ: VERI), a leader in enterprise AI software and services, today announced it has been selected by the U.S. Department of Justice (DOJ) for a $15 million Blanket Purchase Agreement, allowing all DOJ agencies to easily purchase Veritone software and services.
  • Veritone will provide AI-powered software and professional services to rapidly transcribe, translate, locate, redact and extract critical evidence during early case assessment.
  • View the full release here: https://www.businesswire.com/news/home/20231017959792/en/
    Veritone has been selected by the U.S. Department of Justice (DOJ) for a $15 million Blanket Purchase Agreement, allowing all DOJ agencies to easily purchase Veritone software and services.
  • Historically, the DOJ has been procuring the Veritone solutions through Solutions for Enterprise-Wide Procurement contracts on an agency-by-agency basis.

BARDA Expands Partnership With Evidation to Validate and Improve Machine Learning Models for Early Detection of Influenza-like Illness Using Wearables

Retrieved on: 
Tuesday, October 17, 2023

The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.

Key Points: 
  • The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.
  • This contract will also fund research to expand and better understand the potential impact of Evidation’s FluSmart program to encourage protective health behaviors.
  • This is the third BARDA award issued to Evidation to advance understanding and detection tools for respiratory infections.
  • In 2020, BARDA funded follow-on research to investigate if and how machine learning models and novel data from wearables could be used to detect symptoms of COVID-19 infection .

NAMI Los Angeles County Conference - Together Again for Mental Health

Retrieved on: 
Tuesday, October 17, 2023

LOS ANGELES, Oct. 17, 2023 /PRNewswire/ -- After a long hiatus due to Covid-19, The National Alliance on Mental Illness Greater Los Angeles County (NAMI GLAC) and the NAMI Los Angeles community convenes again to provide information on the state of mental health treatment, advocacy, and innovations.

Key Points: 
  • LOS ANGELES, Oct. 17, 2023 /PRNewswire/ -- After a long hiatus due to Covid-19, The National Alliance on Mental Illness Greater Los Angeles County (NAMI GLAC) and the NAMI Los Angeles community convenes again to provide information on the state of mental health treatment, advocacy, and innovations.
  • This one-day conference on Monday, November 13, 2023 at the California Endowment in Downtown Los Angeles focuses on families and individuals affected by mental illness.
  • Highlights of the conference include inspiring keynote presentations and breakout sessions led by passionate advocates and esteemed experts on mental health and advocacy.
  • NAMI provides free mental health programs, services and resources to people living with mental illness and their loved ones in Los Angeles County.

BioAegis Therapeutics Awarded $20 Million BARDA DRIVe Contract to Advance Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Monday, October 16, 2023

NORTH BRUNSWICK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce a second partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS). This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases.

Key Points: 
  • This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS).
  • This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases.
  • Acute Respiratory Distress Syndrome (ARDS) is a condition that can develop as a severe complication of pneumonia, sepsis, or trauma resulting in life-threatening lung injury with fluid leakage into the lungs.
  • Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.

Revive Therapeutics Provides Update of Novel Bucillamine Formulation Development

Retrieved on: 
Wednesday, October 11, 2023

TORONTO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, provides an update on the development of a next generation lyophilized formulation of Bucillamine.

Key Points: 
  • TORONTO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, provides an update on the development of a next generation lyophilized formulation of Bucillamine.
  • Under an agreement with the University of Waterloo, formulation development is ongoing and aims to be completed by the end of December 2023.
  • The Company expects to have its novel lyophilized formulation of Bucillamine ready for clinical evaluation in 2024.
  • The Company intends to explore the novel Bucillamine formulation as a potential treatment for public health medical emergencies including, pandemic influenza, emerging infectious diseases, and medical countermeasure incidents and attacks.