AUC

INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps

Retrieved on: 
Monday, March 11, 2024

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
    INHALE-3 is a 17-week randomized controlled trial with a 13-week extension.
  • Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label.
  • For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024

Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

Spelman College led team awarded a $14 Million National Science Foundation grant focused on transforming the research enterprise

Retrieved on: 
Wednesday, February 21, 2024

NSF announced a $20 million investment across eight institutions through its GRANTED initiative, transforming research support access.

Key Points: 
  • NSF announced a $20 million investment across eight institutions through its GRANTED initiative, transforming research support access.
  • Many of the initiatives previously funded by NSF GRANTED have had a transformative impact, particularly for emerging research and minority-serving institutions.
  • "This $20 million investment through NSF's GRANTED initiative reflects our commitment to breaking down barriers in research access.
  • That’s why I partnered with Spelman College and the National Science Foundation to deliver a $14 million investment in the Atlanta University Center to expand its world-class research capabilities.

HeartBeam Receives Two New US Patents for its Core Cardiac Monitoring Technology

Retrieved on: 
Thursday, March 7, 2024

HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has received two new patents on its core vectorelectrocardiography (VECG) technology from the United States Patent and Trademark Office.

Key Points: 
  • HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has received two new patents on its core vectorelectrocardiography (VECG) technology from the United States Patent and Trademark Office.
  • HeartBeam now has 14 issued and allowed US patents and 4 international patents for its VECG technology which collects 3D signals of the heart and converts them into a 12-lead ECG.
  • For each patient, HeartBeam provides a comparative baseline ECG which aids physicians in gaining richer insights about the patient’s cardiac health.
  • In addition to the 14 issued and allowed US patents and 4 international patents, HeartBeam has 20 pending applications worldwide.

New Data Demonstrate Sunbird Bio’s APEX Diagnostic Test Accurately Differentiates Key Alzheimer’s Disease Biomarker in Blood

Retrieved on: 
Tuesday, March 5, 2024

The data will be shared this week in a poster presentation at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease.

Key Points: 
  • The data will be shared this week in a poster presentation at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease.
  • “These results provide further evidence that the APEX platform has the potential to offer highly sensitive and accurate Alzheimer’s disease diagnosis equivalent to PET scans from a simple blood draw,” said John McDonough, executive chair and CEO of Sunbird Bio.
  • The APEX Aβ test is a blood-based diagnostic that uniquely detects very low levels of disease-specific proteins in blood with high accuracy.
  • EV-associated Aβ in blood are highly correlative and a direct reflection of Aβ build-up in the brain, a key abnormality in Alzheimer’s disease.

Quolet announces completion of Phase 1 healthy volunteer study evaluating the safety and bioavailability of Cannabidiol in a novel formulation intended for treatment of various neurological and psychiatric diseases

Retrieved on: 
Thursday, February 22, 2024

Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).

Key Points: 
  • Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).
  • Researchers at King’s College London partnered with the SEEK group to test whether its bioavailability could be improved by administering CBD in a novel patented lipid formulation.
  • This lipid formulation allows high doses of CBD (200mg) to be administered in capsules including only GRAS and/or pharmaceutical approved ingredients.
  • In one visit they were given the lipid-CBD, and in the other visit they were given standard CBD-only formulation.

Neurocode Launches Groundbreaking pTau217 Blood Test for Alzheimer's Disease Clinical Diagnosis

Retrieved on: 
Monday, March 4, 2024

Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.

Key Points: 
  • Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.
  • Neurocode's new blood test is as accurate as brain imaging or CSF testing for diagnosing Alzheimer's, but is faster, more accessible, less expensive, and less invasive.
  • Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility.
  • Sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site.

Lunit Presents Seven Study Results at ECR 2024: Showcasing AI's Robust Performance in Diverse Clinical Settings

Retrieved on: 
Wednesday, February 28, 2024

SEOUL, South Korea, Feb. 28, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the presentation of seven studies at the European Congress of Radiology (ECR) 2024, to be held in Vienna, Austria, from February 28 to March 3. Four will be presented through oral presentations and three as E-posters.

Key Points: 
  • Four out of seven AI products, including Lunit INSIGHT CXR, showed superior performance compared to human readers.
  • Lunit invites booth visitors at ECR 2024 to explore detailed information on the project and discuss potential future collaborations.
  • "We are proud to present our latest research findings at this year's ECR, demonstrating the robust performance and versatility of our Lunit INSIGHT suite in various clinical settings and scenarios.
  • Join Lunit at booth AI-15 in the EXPO X1 hall to witness how the Lunit INSIGHT suite is shaping the future of radiology across the globe.

Robinhood Markets, Inc. Reports January 2024 Operating Data

Retrieved on: 
Thursday, February 15, 2024

MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Robinhood Markets, Inc. (“Robinhood”) (NASDAQ: HOOD) today reported selected monthly operating data for January 2024:

Key Points: 
  • MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Robinhood Markets, Inc. (“Robinhood”) (NASDAQ: HOOD) today reported selected monthly operating data for January 2024:
    Funded Customers at the end of January were 23.5 million, up approximately 120 thousand from December 2023(1).
  • Assets Under Custody (AUC) at the end of January were $102.4 billion, roughly flat to December 2023.
  • Net Deposits were $3.8 billion in January, translating to a 44% annualized growth rate relative to December 2023 AUC.
  • Over the last twelve months, Net Deposits were $19.5 billion, translating to an annual growth rate of 26% relative to January 2023 AUC.

Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy

Retrieved on: 
Thursday, February 15, 2024

TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl. The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.

Key Points: 
  • TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy.
  • The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl.
  • The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.
  • “The role of EXPAREL as a sciatic nerve block in the popliteal fossa, particularly for pain control following foot and ankle procedures, is pivotal as clinical goals toward outpatient migration continue to grow,” said Gary Schwartz, MD, FASA, Vice Chair of Pain and Anesthesiology at Maimonides Medical Center and lead author on the publication.