IRB

Inventiva announces that screening in the NATiV3, Phase III, clinical trial evaluating lanifibranor in NASH has resumed

Retrieved on: 
Thursday, March 7, 2024

Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.

Key Points: 
  • Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.
  • Other sites and countries are expected to resume screening and randomization activities progressively over the next weeks.
  • Clinical sites located in the United States operating under central IRB have meanwhile resumed screening and randomization activities.
  • Inventiva anticipates the last patient first visit for the NATiV3 clinical trial in the first half of 2024.

Ludwig Enterprises Inc. (OTC:LUDG) Announces Patent Filing for Breakthrough in Identifying mRNA Genes Associated with Certain Cancers

Retrieved on: 
Wednesday, March 6, 2024

The Company’s mRNA for Life™ is a one-of-the-kind noninvasive at-home sceening test for genes that could be associated with cancer.

Key Points: 
  • The Company’s mRNA for Life™ is a one-of-the-kind noninvasive at-home sceening test for genes that could be associated with cancer.
  • This test allows a person to make themselves a priority and could be a signal to seek a medical examination.
  • The Company selected for measurement 48 distinct mRNA genes in stored specimens from patients afflicted with breast, bladder or colorectal cancer.
  • mRNA levels were analyzed using machine learning artificial intelligence (AI) to identify markers of genetic expression involved in separate cancers.

Bionano Reports Fourth Quarter and Full-Year 2023 Results and Provides Revenue Outlook for 2024

Retrieved on: 
Tuesday, March 5, 2024

Total revenue for the fourth quarter of 2023 was $10.7 million, an increase of 30% compared to the fourth quarter of 2022.

Key Points: 
  • Total revenue for the fourth quarter of 2023 was $10.7 million, an increase of 30% compared to the fourth quarter of 2022.
  • GAAP gross margin for the fourth quarter of 2023 was 23%, which was slightly higher than the 22% GAAP gross margin reported for the fourth quarter of 2022.
  • Fourth quarter 2023 GAAP operating expense was $27.4 million, compared to $39.3 million in the fourth quarter of 2022.
  • Fourth quarter 2023 non-GAAP operating expense was $27.3 million, compared to $30.6 million in the fourth quarter of 2022.

Tiny Health, Pioneer of the First At-Home Baby Gut Microbiome Test, Aims to Address the Pediatric Chronic Conditions Crisis

Retrieved on: 
Tuesday, March 5, 2024

The partnership enables Tiny Health to continue trailblazing the gut health testing category and avert the pediatric chronic conditions crisis.

Key Points: 
  • The partnership enables Tiny Health to continue trailblazing the gut health testing category and avert the pediatric chronic conditions crisis.
  • Families are facing a pediatric chronic conditions crisis, with increasing rates of eczema, asthma, diabetes, obesity, food allergies, ADHD, autoimmune diseases, and more.
  • I founded Tiny Health to bridge the gap in the market, help address the pediatric chronic conditions crisis, and empower families to take a proactive approach to their lifelong health.
  • Since its inception, Tiny Health has pioneered the family gut testing category including:
    Established the first, at-home gut microbiome test for babies.

Barclays and Blackstone Credit & Insurance Agree to Sale of Credit Card Receivables

Retrieved on: 
Tuesday, February 27, 2024

Barclays PLC ("Barclays") and Blackstone Credit & Insurance (“Blackstone”) today announced that Barclays Bank Delaware ("BBDE") has entered into an agreement with insurance accounts managed by Blackstone’s Asset Based Finance group, to sell approximately US$1.1 billion of currently outstanding credit card receivables (the “Transaction”) in relation to a defined set of Barclays-branded credit card accounts in the United States of America (the “Accounts”).

Key Points: 
  • Barclays PLC ("Barclays") and Blackstone Credit & Insurance (“Blackstone”) today announced that Barclays Bank Delaware ("BBDE") has entered into an agreement with insurance accounts managed by Blackstone’s Asset Based Finance group, to sell approximately US$1.1 billion of currently outstanding credit card receivables (the “Transaction”) in relation to a defined set of Barclays-branded credit card accounts in the United States of America (the “Accounts”).
  • This is the first in a series of activities Barclays plans to conduct to reduce its risk-weighted assets (RWAs) and create additional lending capacity for BBDE.
  • As part of the Transaction, BBDE will enter into a long-term strategic forward flow sale and servicing arrangement with Blackstone related to the Accounts.
  • Barclays Bank PLC will invest into the Transaction alongside Blackstone’s insurance accounts.

Principal IRB Becomes Univo IRB With Support From QHP Capital

Retrieved on: 
Tuesday, February 20, 2024

Today, Univo IRB was announced as the new company name for Principal IRB.

Key Points: 
  • Today, Univo IRB was announced as the new company name for Principal IRB.
  • Univo IRB is a next generation institutional review board (IRB) recently acquired by QHP Capital, an investment manager exclusively focused on building and supporting tech-enabled life sciences and pharma services companies.
  • Univo IRB is focused on full-scale IRB services, bringing decades of IRB and clinical operations experience to support today’s clinical trials.
  • At last week’s SCOPE Summit in Orlando, Florida, Univo IRB shared its plans to bring the voice of patients closer to research by creating an agile and efficient IRB review experience.

HealthTree Foundation Announces Launch of HealthTree Research Hub in Multiple Myeloma

Retrieved on: 
Friday, March 1, 2024

SALT LAKE CITY, Utah, March 1, 2024 /PRNewswire/ -- HealthTree Foundation, a global non-profit organization using cutting-edge technology that unites patients and researchers to accelerate cures, is excited to announce the release of its highly anticipated HealthTree Research Hub portal.

Key Points: 
  • HealthTree Research Hub is an online research portal that facilitates real-world data (RWD) research.
  • HealthTree Research Hub provides researchers access to over 14,000 myeloma patients who contribute anonymized data to the HealthTree Cure Hub patient portal.
  • HealthTree Research Hub will facilitate over 100 research projects in the next 20 months for myeloma researchers.
  • HealthTree Research Hub will additionally be open for beta research projects in lymphoma, leukemia and MPNs in 2024.

Phylos® and People Science® Announce Results of IRB-Backed Controlled Research Study on the Energizing Effects of THCV

Retrieved on: 
Tuesday, February 27, 2024

PORTLAND, Ore., Feb. 27, 2024 /PRNewswire/ -- Cannabis genetics company Phylos®, along with People Science, a direct-to-consumer scientific research and technology company, has conducted an IRB-approved, double-blind clinical research study on the effects of rare cannabinoid tetrahydrocannabivarin (THCV). Results of the study found that Natural Natural™ THCV by Phylos significantly increased energy, activity, motivation, and well-being compared to placebo, without the fatigue and munchies associated with THC consumption.

Key Points: 
  • Results of the study found that Natural Natural ™ THCV by Phylos significantly increased energy, activity, motivation, and well-being compared to placebo, without the fatigue and munchies associated with THC consumption.
  • "This study signifies a pivotal moment for the cannabis industry in understanding the effect of THCV in combination with THC," according to Alisha Holloway, PhD, Chief Scientific Officer at Phylos.
  • "The Natural Natural THCV study allows us to leverage our exceptional plants in the advancement of targeted cannabis products, and to chart new territories in understanding the efficacy of natural cannabinoids."
  • Research participants ingested unmedicated placebo gummies, THC-only gummies, and gummies infused with extract from Get Sh!t Done™ (GSD), a THCV-dominant plant bred by Phylos.

MENOPAUSE HOT FLASHES EXTINGUISHED

Retrieved on: 
Tuesday, February 27, 2024

DENVER, Feb. 27, 2024 /PRNewswire/ -- Today, health and wellness company, Rebalance Health announced results and outcomes from a 104 subject IRB-approved open label study focused on the company's new Hot Flash System™.  The study revealed that women saw an average of 80% reduction in hot flashes and other menopausal symptoms, with no side effects. The initial findings were first published by the North American Menopause Society and have since been finalized and published by a second peer reviewed journal, The Journal of Nutraceuticals and Food Science.

Key Points: 
  • New Study from Rebalance Health Shows 80% Decrease in Hot Flashes, Measurable Reduction in Other Menopause Symptoms
    DENVER, Feb. 27, 2024 /PRNewswire/ -- Today, health and wellness company, Rebalance Health announced results and outcomes from a 104 subject IRB-approved open label study focused on the company's new Hot Flash System™.
  • The study revealed that women saw an average of 80% reduction in hot flashes and other menopausal symptoms, with no side effects.
  • The initial findings were first published by the North American Menopause Society and have since been finalized and published by a second peer reviewed journal, The Journal of Nutraceuticals and Food Science .
  • Rebalance Health's products support cortisol levels through a proprietary delivery system that allows the body to rebalance hormones naturally.

Philip R. Lane: The banking channel of monetary policy

Retrieved on: 
Friday, February 16, 2024

for rates, credit growth in deviation from the start of the cycle (t) in p.p.

Key Points: 
    • for rates, credit growth in deviation from the start of the cycle (t) in p.p.
    • Starting months correspond to the month immediately preceding the first hike or explicit announcement of the hike of the cycle.
    • The dotted lines shows counterfactuals for lending rates and lending volumes, taking December 2021 as the last observation and
      projecting volumes conditional on the path of monetary policy rates.
    • The one for lending volumes is based on the BVAR model in Altavilla,
      Giannone, and Lenza (2016).
    • Composite funding costs are a weighted average of deposit rates
      and average monthly bond yields, with outstanding amounts as weights.
    • Right chart shows
      the contributions of the components to the change in the composite bank funding cost
      between December 2021 and November 2023.
    • Latest observations: 8 February 2024 for bond yields; December 2023 for other series.
    • Notes: ?Others? include shares (listed and not listed as well as those issued by investment
      funds), and insurance and pension schemes.
    • Retail

      Specialised

      Universal

      10

      10

      8

      8

      6

      6

      4

      4

      2

      2

      0

      0

      -2

      -2

      -4
      Jan-20 Aug-20 Mar-21 Oct-21 May-22 Dec-22 Jul-23

      -4

      Sources: ECB (iBSI, iMIR) MPC Task Force on Banking Analysis and ECB calculations.

    • Investment refers to the net
      change in property plant and equipment over assets; cash refers to cash and cash
      equivalents over assets.
    • Households
      loans, credit standards and loan demand
      Rubric
      Changes in credit standards for
      loans to households, and
      contributing factors
      (net percentage)

      0

      30

      -40

      20

      Sources: ECB (BSI) and ECB calculations.

    • Low-income households are those in the bottom 20 per cent
      of the income distribution; high-income households are those in the top 20 per cent.