Critical Care Medicine (journal)

Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published in The New England Journal of Medicine

Retrieved on: 
Lunedì, Maggio 20, 2024

TARRYTOWN, N.Y. and PARIS, May 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented late-breaking data from the NOTUS Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). The NOTUS trial confirmed the positive results demonstrated in the landmark Phase 3 BOREAS trial, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM).

Key Points: 
  • The NOTUS trial confirmed the positive results demonstrated in the landmark Phase 3 BOREAS trial, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM) .
  • “In NOTUS, dupilumab reduced exacerbations by a magnitude never seen before with an investigational biologic in a Phase 3 COPD clinical trial.
  • These comprehensive results reinforce that, if approved, dupilumab could provide a first-of-its-kind medical advancement for the COPD community.”
    As presented and published, the NOTUS trial met its primary and key secondary endpoints.
  • AEs more commonly observed with placebo than Dupixent included COPD (7.8% placebo, 4.9% Dupixent).

Press Release: Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Retrieved on: 
Lunedì, Maggio 20, 2024

The NOTUS study confirmed the positive results demonstrated in the landmark phase 3 BOREAS study, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM) .

Key Points: 
  • The NOTUS study confirmed the positive results demonstrated in the landmark phase 3 BOREAS study, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM) .
  • In NOTUS, dupilumab reduced exacerbations by a magnitude never seen before with an investigational biologic in a phase 3 COPD clinical study.
  • These comprehensive results reinforce that, if approved, dupilumab could provide a first-of-its-kind medical advancement for the COPD community.”
    As presented and published, the NOTUS study met its primary and key secondary endpoints.
  • AEs more commonly observed with placebo than Dupixent included COPD (7.8% placebo, 4.9% Dupixent).

Biodesix to Present New Data on the Nodify XL2® Test at ATS 2024 Annual Meeting

Retrieved on: 
Martedì, Maggio 21, 2024

Emphysema is a common comorbid pulmonary condition in patients with lung nodules and presents unique diagnostic and treatment challenges.

Key Points: 
  • Emphysema is a common comorbid pulmonary condition in patients with lung nodules and presents unique diagnostic and treatment challenges.
  • These results suggest that the test can assist with ruling out lung cancer regardless of a patient’s emphysema status.
  • "During the course of emphysema treatment, many of our patients present with suspicious lung nodules," said Dr. Romero.
  • Some nodules need to be followed for up to two years to establish stability, but many patients cannot wait this long.

Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Lunedì, Aprile 15, 2024

AUSTIN, Texas, April 15, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (“Aileron”, the “Company”, “we”, “our” or “us”) (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • We expect to report topline results from the ongoing Phase 1b study of LTI-03 in the third quarter of this year.
  • Net Loss: Net loss for the quarter ended December 31, 2023, was $7.3 million, compared to $4.5 million for the quarter ended December 31, 2022.
  • The basic and diluted net loss per share for the quarter ended December 31, 2023 was $1.54 compared to $1.00 for the quarter ended December 31, 2022.
  • The basic and diluted net loss per share for the full-year 2023 was $3.42 compared to $6.02 for the full-year 2022.

Liberate Medical Announces PREVENT Study with $6.5M Grant Funding from the US DoD – Enrolls First Patients Globally

Retrieved on: 
Martedì, Aprile 30, 2024

Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life and death.

Key Points: 
  • Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life and death.
  • PREVENT is a global collaborative effort that plans to enroll 272 patients from 25 centers across the US, EU and Australia.
  • Liberate Medical extends its deepest gratitude and congratulations to these institutions for their commitment and swift implementation of the PREVENT study.
  • "The initiation of patient enrollment in the PREVENT trial is a landmark event for Liberate Medical and innovation in critical care medicine.

Attovia Enhances Clinical and Development Expertise with Appointment of Chief Medical Officer and Clinical and Scientific Advisory Boards

Retrieved on: 
Martedì, Marzo 26, 2024

FREMONT, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Attovia Therapeutics today announced the appointment of Hubert Chen, M.D., MPH, as Chief Medical Officer, effective March 21, 2024. Dr. Chen brings extensive clinical and industry leadership experience in drug development and joins Attovia from Krystal Biotech (NASDAQ: KRYS), where he was Senior Vice President of Clinical Development. At Attovia, Dr. Chen will lead the company’s clinical development and regulatory functions and will serve on the Executive Committee.

Key Points: 
  • Dr. Chen brings extensive clinical and industry leadership experience in drug development and joins Attovia from Krystal Biotech (NASDAQ: KRYS), where he was Senior Vice President of Clinical Development.
  • At Attovia, Dr. Chen will lead the company’s clinical development and regulatory functions and will serve on the Executive Committee.
  • Prior to Krystal, Dr. Chen was at Genentech/Roche where he held clinical leadership positions across both early and late-stage development.
  • To support the ongoing strategic development of the Attobody platform and advancement of the Company’s emerging pipeline candidates, Attovia has established Clinical and Scientific Advisory Boards comprised of biopharmaceutical industry veterans and academic experts.

Savara to Present New Data on Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2024

Retrieved on: 
Lunedì, Aprile 8, 2024

The abstracts will be published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM) on May 1, 2024.

Key Points: 
  • The abstracts will be published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM) on May 1, 2024.
  • For more details about the ATS International Conference please visit https://conference.thoracic.org/index.php .
  • Pulmonary Alveolar Proteinosis (PAP): Pathophysiology, Diagnosis, and Management
    Bruce Trapnell, M.D., M.S.
  • will provide an overview of PAP, including the burden of this rare lung disease, the hallmark signs and symptoms of autoimmune PAP (aPAP), the most common form of PAP, and the path to diagnosing aPAP.

Upstream Bio Announces Appointment of Rand Sutherland as CEO and Additions to Leadership Team

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Martedì, Aprile 2, 2024

Upstream Bio , a clinical-stage biotech company advancing verekitug (UPB-101) for respiratory disorders, today announced strategic leadership changes including the appointment of Rand Sutherland, MD, as Chief Executive Officer.

Key Points: 
  • Upstream Bio , a clinical-stage biotech company advancing verekitug (UPB-101) for respiratory disorders, today announced strategic leadership changes including the appointment of Rand Sutherland, MD, as Chief Executive Officer.
  • “I am thrilled to join Upstream Bio as CEO.
  • By evolving and building our leadership team with these additions, we are further positioning Upstream Bio to become a leader in the immunotherapy landscape.
  • I am pleased to welcome Rand, Mike and Lisa to the Upstream Bio team.”
    Dr. Sutherland joins Upstream Bio with more than 25 years of business and clinical experience, having most recently served as CEO of Seeker Biologics, and before that as President of Translate Bio prior to its acquisition by Sanofi.

The Inner Circle acknowledges Antony Jackson Arumairaj, MD as a Top Pinnacle Physician

Retrieved on: 
Martedì, Aprile 2, 2024

JERSEY CITY, N.J., April 2, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Antony Jackson Arumairaj, MD is acknowledged as a Top Pinnacle Physician for his contributions as a Distinguished Internal Medicine Specialist.

Key Points: 
  • JERSEY CITY, N.J., April 2, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Antony Jackson Arumairaj, MD is acknowledged as a Top Pinnacle Physician for his contributions as a Distinguished Internal Medicine Specialist.
  • In this capacity, he not only provides exceptional patient care but also plays a pivotal role in teaching and mentoring medical students.
  • His dedication to the well-being of his patients and commitment to medical education make him a valuable asset to the healthcare community.
  • He aims to complete his Pulmonary Critical Care fellowship and become an Attending Physician at a university hospital.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
Mercoledì, Marzo 27, 2024

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.