American Journal of Respiratory and Critical Care Medicine

American Journal of Respiratory and Critical Care Medicine Publishes Full, Positive Results of Apnimed’s MARIPOSA Study on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea

Retrieved on: 
Tuesday, October 10, 2023
BMI, Nursing care plan, Xerostomia, Food, Female, AJRCCM, Desaturation, American Journal, American Journal of Respiratory and Critical Care Medicine, Confusional arousals, ST, AHI, Safety, Nausea, Insomnia, CPAP, Hypopnea, Fatigue, Research, Obstructive sleep apnea, Sleep, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Critical Care Medicine (journal), IQR, Sleep apnea, Șaeș, Patient, Apnea–hypopnea index, Pharmaceutical industry, Medical imaging

AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.

Key Points: 
  • AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.
  • The study met its primary endpoint, reduction in Apnea-Hypopnea Index (AHI4, 4% desaturation definition for hypopneas).
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Monday, September 11, 2023
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Heart, European Respiratory Society, International, PA, PAH, Echocardiography, The New England Journal of Medicine, MRK, Head, American Journal of Respiratory and Critical Care Medicine, Merck & Co., ERS, Resistance, Patient, N-terminal prohormone of brain natriuretic peptide, Mercury (element), Disease, Mortality, WHO, European Respiratory Journal, Orthostatic hypertension, International Congress on Tuberculosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Safety, Pharmaceutical industry, RV, Merck

Merck submitted an application for regulatory approval of sotatercept to the U.S. Food and Drug Administration and plans to submit applications to additional regulatory agencies worldwide.

Key Points: 
  • Merck submitted an application for regulatory approval of sotatercept to the U.S. Food and Drug Administration and plans to submit applications to additional regulatory agencies worldwide.
  • An exploratory post-hoc analysis from the STELLAR trial evaluated the effects of sotatercept on select hemodynamic parameters and right-ventricle (RV) function.
  • The STELLAR trial enrolled 323 adults with PAH, randomized to receive sotatercept (n=163) or placebo (n=160), on top of background therapy.
  • In the analysis, after 24 weeks, sotatercept was associated with meaningful improvements in certain measures of hemodynamic status and RV function.

Despite Fears to the Contrary, Canadian Wildfire Smoke Exposure Was Not Much Worse Than A Bad Pollen Day in New York City

Retrieved on: 
Wednesday, August 23, 2023
Mental Hygiene, New York State Department of Environmental Conservation, Asthma, Atmosphere, Critical Care Medicine (journal), Environmental protection, Stroke, NYU, Splenic infarction, New York University Grossman School of Medicine, Pollen, Inflammation, Sulfur, NYU Langone Health, New Yorker, Oxidative stress, American Journal, Soil, Doctor of Science, Population health, Smoke, Particulates, Copper, New York City Department of Health and Mental Hygiene, Potassium, Air pollution, American Journal of Respiratory and Critical Care Medicine, Pharmaceutical industry, Rare-earth element, Health, Medicine

NEW YORK, Aug. 23, 2023 /PRNewswire/ -- New Yorkers can apparently breathe a sigh of relief, at least for now.

Key Points: 
  • NEW YORK, Aug. 23, 2023 /PRNewswire/ -- New Yorkers can apparently breathe a sigh of relief, at least for now.
  • However, authors of a new study say other possible health effects, such as possible heart attacks and stroke, still need to be investigated.
  • The researchers caution that while no deaths tied to the wildfire smoke were reported in June, asthma remains a serious and potentially life-threatening lung disease.
  • Both are found in average New York City air and are known causes of oxidative stress when inhaled.

Verona Pharma Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 3, 2023
Abstract, Maintenance, US Foods, D, SG, Information technology, Marketing, Conference call, Pharming, ATS, CMC, New Drug Application, NDA, Quality of life, EDT, AJRCCM, Chronic obstructive pulmonary disease, VRNA, American Journal, Data analysis, Patient, Risk, Annual general meeting, Research, FDA, Food, American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine (journal), BST, Fine chemical, Pharmaceutical industry, Rare-earth element, Online shopping, COPD, Conference

LONDON and RALEIGH, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the second quarter ended June 30, 2023, and provides a corporate update.

Key Points: 
  • Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST
    LONDON and RALEIGH, N.C., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the second quarter ended June 30, 2023, and provides a corporate update.
  • Net loss: Net loss was $8.8 million for the second quarter ended June 30, 2023 (Q2 2022: net loss $17.8 million).
  • Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Thursday, August 3, 2023, to discuss the second quarter 2023 financial results and the corporate update.
  • An electronic copy of the second quarter 2023 results press release will also be made available today on the Company’s website.

U.S. FDA accepts supplemental New Drug Application for OFEV® (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease

Retrieved on: 
Tuesday, July 25, 2023
European Respiratory Society, Medical Affairs Bureau, Diarrhea, New Drug Application, ILD, ATSF, American Journal of Respiratory and Critical Care Medicine, Children's Hospital, Children's Hospital Colorado, ERS, Pulmonary fibrosis, Boehringer Ingelheim, Shanda, ERJ, Patient, FCCP, Diagnosis, Ageing, European Respiratory Journal, FDA, International Congress on Tuberculosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Food, Safety, Pharmaceutical industry

"If approved, OFEV would be the first and only approved treatment for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease, representing an important step forward for these patients."

Key Points: 
  • "If approved, OFEV would be the first and only approved treatment for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease, representing an important step forward for these patients."
  • In children and adolescents with fibrosing ILD, a weight-based dosing regimen resulted in exposure of nintedanib similar to adults and with a similar safety profile.
  • The most common adverse event associated with nintedanib compared to placebo in the InPedILD trial was diarrhea.
  • The complete results were published in the European Respiratory Journal (ERJ) and presented at the European Respiratory Society (ERS) International Congress in September 2022.

Verona Pharma Announces Publication of Phase 3 ENHANCE Data in the American Journal of Respiratory and Critical Care Medicine

Retrieved on: 
Wednesday, June 28, 2023
COPD, Maintenance, Multicenter Automatic Defibrillator Implantation Trial, PDE4, US Foods, User experience, Section, Novel, AJRCCM, Chronic obstructive pulmonary disease, VRNA, American Journal, MD, Patient, Manuscript, Risk, Physician, Treatment, Food, American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine (journal), Pharmaceutical industry

LONDON and RALEIGH, N.C., June 28, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the American Journal of Respiratory and Critical Care Medicine (“AJRCCM”) has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease (“COPD”).

Key Points: 
  • LONDON and RALEIGH, N.C., June 28, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the American Journal of Respiratory and Critical Care Medicine (“AJRCCM”) has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease (“COPD”).
  • It follows announcements of top-line data from the ENHANCE-1 and ENHANCE-2 trials in December and August 2022, respectively.
  • If approved, it is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years.
  • I believe ensifentrine, with its novel bronchodilator and non-steroidal anti-inflammatory activity, has the potential to change the treatment paradigm for COPD patients.”

Axalbion Presented Promising Phase 2 Clinical Data in Chronic Cough with AX-8, a Novel TRPM8 Agonist, in an Oral Presentation at the American Thoracic Society (ATS) 2023 International Conference

Retrieved on: 
Monday, May 22, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, University of Manchester, Depression, University, Anxiety, ATS, American Thoracic Society, Cough, Chronic cough, Sleep, American Journal, International Conference on Cold Fusion, MD, Patient, Social stigma, Social isolation, TRPM8, Irritation, EudraCT, Conference, American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine (journal), Urinary incontinence, Pharmaceutical industry, Poultry farming

( ClinicalTrials.gov NCT04866563 ; EudraCT Number 2021-000844-23).

Key Points: 
  • ( ClinicalTrials.gov NCT04866563 ; EudraCT Number 2021-000844-23).
  • “Refractory chronic cough is a burdensome condition that significantly impacts a patient’s quality of life, leading to urinary incontinence, social stigma, sleep disturbances, anxiety, depression and social isolation.
  • AX-8 shows promising results in this proof-of-concept study with a robust reduction in cough frequency in patients experiencing the greatest throat discomfort.
  • “We believe that AX-8 acts as a counterirritant that activates TRPM8 channels in throat sensory fibers.

Verona Pharma Reports First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 9, 2023
COPD, Maintenance, Abstract, US Foods, D, Conference call, Critical Care Medicine (journal), Pharming, New Drug Application, ATS, Clinical trial, NDA, American Journal of Respiratory and Critical Care Medicine, Quality of life, EDT, Chronic obstructive pulmonary disease, VRNA, Patient, Webcast, Research, FDA, Food, Safety, BST, Pharmaceutical industry, Generic drug, Online shopping, Greater China, Conference

LONDON and RALEIGH, N.C., May 09, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the first quarter ended March 31, 2023, and provides a corporate update.

Key Points: 
  • Conference call today at 9:00 a.m. EDT / 2:00 p.m. BST
    LONDON and RALEIGH, N.C., May 09, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the first quarter ended March 31, 2023, and provides a corporate update.
  • An overview of the ENHANCE trial results will be presented as part of the clinical trials symposium reserved for highlighting new breakthroughs.
  • Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EDT / 2:00 p.m. BST on Tuesday, May 9, 2023, to discuss the first quarter 2023 financial results and the corporate update.
  • An electronic copy of the first quarter 2023 results press release will also be made available today on the Company’s website.

Verona Pharma to Present Expanded Analyses of Positive Phase 3 ENHANCE Studies in COPD in Multiple Presentations at ATS 2023

Retrieved on: 
Tuesday, May 2, 2023
COPD, Abstract, Abstract (summary), Conference call, Pharming, ATS, Section, American Journal of Respiratory and Critical Care Medicine, EDT, Chronic obstructive pulmonary disease, VRNA, Clinical trial, MD, Physician, Risk, Webcast, Conference, Critical Care Medicine (journal), BST, Communications satellite, Pharmaceutical industry, News

LONDON and RALEIGH, N.C., May 02, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces 12 abstracts, including a mini symposium, and a clinical trials symposium, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) have been accepted by the American Thoracic Society International Conference (“ATS”) 2023. An overview of the ENHANCE trial results will be presented as part of the clinical trials symposium ‘Breaking News: Clinical Trial Results in Pulmonary Medicine’ reserved for highlighting new breakthroughs. The abstracts are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine. Verona Pharma will host a webcast and conference call on Tuesday, May 23, 2023, to review these data.

Key Points: 
  • The abstracts are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.
  • Verona Pharma will host a webcast and conference call on Tuesday, May 23, 2023, to review these data.
  • D., Verona Pharma’s President and Chief Executive Officer, said: “We are looking forward to providing additional analyses of the positive results from the Phase 3 ENHANCE trials that highlight key areas of interest for physicians.
  • Details of Verona Pharma’s abstracts and the symposia are listed below and linked to the ATS website.

Vertex Announces U.S. FDA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 2 Through 5 With Certain Mutations

Retrieved on: 
Wednesday, April 26, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Genetics, Clinical Trials, Medical Affairs Bureau, VRTX, Pediatrics, University, Critical Care Medicine (journal), European Medicines Agency, Pharmacokinetics, Mutation, Medication, Cystic fibrosis transmembrane conductance regulator, Assistant, EMA, CFTR, American Journal, Cystic fibrosis, Medicines and Healthcare products Regulatory Agency, Principal, Elexacaftor/tezacaftor/ivacaftor, Regulation of tobacco by the U.S. Food and Drug Administration, CF, UNC School of Medicine, Safety, Food, American Journal of Respiratory and Critical Care Medicine, MHRA, Vertex Pharmaceuticals, Vaccine, Pharmaceutical industry, EU, Medicine, Vertex

“Since its initial approval, TRIKAFTA has had a significant impact on the CF community, transforming the lives of thousands of people living with cystic fibrosis,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex.

Key Points: 
  • “Since its initial approval, TRIKAFTA has had a significant impact on the CF community, transforming the lives of thousands of people living with cystic fibrosis,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex.
  • The data from this study were recently published in the American Journal of Respiratory and Critical Care Medicine .
  • Additionally, Vertex has submitted applications for the use of TRIKAFTA®/KAFTRIO® in children ages 2 through 5 years of age to other global regulatory authorities, including the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
  • For more information on TRIKAFTA®, patient assistance programs or to find additional eligibility details, visit TRIKAFTA.com , VertexGPS.com or vertextreatments.com .