APAP

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

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星期日, 五月 19, 2024
Health, Infectious Diseases, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, American Thoracic Society, Conference, Patient, Diagnosis, PAP, Pulmonary alveolar proteinosis, Poster, APAP, ATS, Inc., Pharmaceutical industry

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the American Thoracic Society (ATS) 2024 International Conference that is taking place May 17-22, 2024, in San Diego, CA.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented a poster at the American Thoracic Society (ATS) 2024 International Conference that is taking place May 17-22, 2024, in San Diego, CA.
  • Below are summaries of the posters presented:
    Poster Board 701: “Healthcare Burden of Pulmonary Alveolar Proteinosis” presented by E. Lee, M.D., Ph.D.; sponsored by Savara Inc.
  • Presented data from a retrospective cohort analysis using a longitudinal claims database (IPM.ai) comparing the clinical and economic burden of a sample of 2,312 pulmonary alveolar proteinosis (PAP) patients to 9,247 non-PAP matched controls.
  • Development of a novel laboratory test for the detection of GM-CSF antibodies to aid in the diagnosis of individuals at-risk for autoimmune pulmonary alveolar proteinosis (aPAP).

$23.1 Billion Sleep Apnea Devices Market, Industry Trends and Global Forecasts 2024-2035 - ResearchAndMarkets.com

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星期二, 五月 14, 2024
Medical Devices, Health, Obstructive sleep apnea, ResMed, Ventilation, USD, Interest, Prevalence, Diagnosis, Overalls, Ageing, Non-invasive ventilation, Administration, Sleep apnea, Research, Growth, LivaNova, Hub, Woman, Central sleep apnea, CPAP, Polysomnography, APAP, Pharmaceutical industry

The growth in the sleep apnea devices market share over the next decade is likely to be the result of anticipated increase in patient population and rise in the demand for sleep apnea devices for sleep apnea treatment.

Key Points: 
  • The growth in the sleep apnea devices market share over the next decade is likely to be the result of anticipated increase in patient population and rise in the demand for sleep apnea devices for sleep apnea treatment.
  • The global sleep apnea diagnostic devices market is categorized into polysomnography devices and home sleep apnea testing devices.
  • The market report features an extensive study of the current market landscape, sleep apnea devices market share, market size, market analysis, market forecast and future opportunities for the sleep apnea companies involved in the development of sleep apnea medical devices and sleep apnea drugs.
  • Sleep Apnea Devices Market Analysis: Sleep Apnea Therapeutic Devices Hold Majority Market Share
    The global sleep apnea devices market is estimated to be worth USD 13.5 billion in 2024.

Mallinckrodt plc Reports First Quarter 2024 Financial Results and Reaffirms Full Year Guidance

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星期四, 五月 9, 2024
NICU, State, Conversation, APAP, Hospital, Security (finance), Growth, API, Result, Risk, Patient, Nitric oxide, Analysis, Ratio, Adjustment, GAAP, The Company, Pharmaceutical industry

DUBLIN, May 9, 2024 /PRNewswire/ -- Mallinckrodt plc  ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the first quarter ended March 29, 2024.1

Key Points: 
  • Mallinckrodt's net sales in the first quarter of 2024 were $467.8 million, as compared to $424.6 million in the first quarter of 2023.
  • Acthar Gel reported net sales of $102.8 million for the first quarter of 2024, representing an increase of 25.4% versus the prior year quarter.
  • Terlivaz reported net sales of $6.0 million in the first quarter of 2024, reflecting Mallinckrodt's successful ongoing launch of the product.
  • Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the first quarter.

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

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星期一, 四月 8, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Critical Care Medicine (journal), PAP, Pulmonary alveolar proteinosis, AJRCCM, Abstract, American Journal, Conference, APAP, Diagnosis

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.

Partner Therapeutics' Leukine® (sargramostim) Receives Approval in Japan to Treat Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

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星期三, 四月 3, 2024
Monocyte, GM, Serum, Disease, Partnership, Patient, GM-CSF, DNA, PTX, Doctor of Philosophy, Respiratory failure, Pleasure, Trade name, Granulocyte-macrophage colony-stimulating factor, Pulmonary fibrosis, APAP, Therapy, Niigata University, Pulmonary alveolar proteinosis, Division, Partner, PMDA, PAGE, CEA, WLL, Hospital

LEXINGTON, Mass., April 3, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced that its partner Nobelpharma received approval from the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for the inhaled use of Leukine (sargramostim), branded in Japan as Sargmalin, to treat aPAP. PTx licensed rights for certain indications in Japan to Nobelpharma in 2022. Leukine is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. Leukine is not approved outside Japan for aPAP or as an inhalation therapy. Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.

Key Points: 
  • Leukine is not approved outside Japan for aPAP or as an inhalation therapy.
  • Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.
  • Inhaled recombinant GM-CSF reduces the need for whole lung lavage and improves gas exchange in autoimmune pulmonary alveolar proteinosis patients.
  • Autoimmune pulmonary alveolar proteinosis.

Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides 2024 Guidance

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星期二, 三月 26, 2024
Automation, New Board, The Company, Pressure, ADHD, APAP, Growth, Health, Patient, Chairperson, Tablet, Hospital, Nitric oxide, Successor, NICU, GAAP, Morphine, EVOLVE, Marketing, FDA, Pharmaceutical industry

Adjusted gross profit as a percentage of sales was 62.3% for the fourth quarter of 2023, as compared to 65.9% for the fourth quarter of 2022.

Key Points: 
  • Adjusted gross profit as a percentage of sales was 62.3% for the fourth quarter of 2023, as compared to 65.9% for the fourth quarter of 2022.
  • Mallinckrodt expects fiscal 2024 Acthar Gel net revenue to decline in the low single digits, compared with fiscal 2023.
  • Mallinckrodt received FDA clearance of the INOmax EVOLVE DS Delivery System in the fourth quarter of 2023.
  • Please see the "Reconciliation of Non-GAAP Financial Guidance" included in this release for a reconciliation of GAAP and non-GAAP financial measures for the fourth quarter of 2023 and fiscal 2023.

Sleep Apnea Devices Market, Industry Trends and Global Forecasts, 2035

Retrieved on: 
星期五, 三月 15, 2024
Diagnosis, ResMed, Non-invasive ventilation, Sleep apnea, CPAP, Growth, Prevalence, APAP, LivaNova, Obstructive sleep apnea, Polysomnography, Ageing, Ventilation, Research, Overalls, Central sleep apnea, Woman, Hub, Interest, USD, Administration, Pharmaceutical industry

The growth in the sleep apnea devices market share over the next decade is likely to be the result of anticipated increase in patient population and rise in the demand for sleep apnea devices for sleep apnea treatment.

Key Points: 
  • The growth in the sleep apnea devices market share over the next decade is likely to be the result of anticipated increase in patient population and rise in the demand for sleep apnea devices for sleep apnea treatment.
  • The global sleep apnea diagnostic devices market is categorized into polysomnography devices and home sleep apnea testing devices.
  • The market report features an extensive study of the current market landscape, sleep apnea devices market share, market size, market analysis, market forecast and future opportunities for the sleep apnea companies involved in the development of sleep apnea medical devices and sleep apnea drugs.
  • Sleep Apnea Devices Market Analysis: Sleep Apnea Therapeutic Devices Hold Majority Market Share
    The global sleep apnea devices market is estimated to be worth USD 13.5 billion in 2024.

Savara Reports Fourth Quarter/Year-End 2023 Financial Results and Provides Business Update

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星期四, 三月 7, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Research, Chemistry, Investment, GM, Pulmonology, BLA, APAP, Patient, Disease, Chair, Inc., Cryptocurrency

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2023 and provided a business update.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2023 and provided a business update.
  • Research and development expenses for the fourth quarter of 2023 and 2022 were $12.7 million and $7.6 million, respectively.
  • General and administrative expenses for the fourth quarter of 2023 and 2022 were $4.9 million and $3.2 million, respectively.
  • As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of $162.3 million.

Savara Introduces aPAP ClearPath™, a GM-CSF Autoantibody Blood Test to Detect Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

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星期四, 十二月 21, 2023
Medical Supplies, Medical Devices, Health, Clinical Trials, Pharmaceutical, Biotechnology, Associate, Autoantibody, Division, Physician, GM, Critical Care Medicine (journal), Chair, Prevalence, Disease, University of Florida, GM-CSF, CLIA, Clinical Laboratory, Serum, University, Patient, Diagnosis, PAP, APAP, Inc., Pharmaceutical industry

The aPAP ClearPath™ test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum.

Key Points: 
  • The aPAP ClearPath™ test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum.
  • “I congratulate Savara for making this simple test broadly available for physicians in the U.S.”
    Only a physician or healthcare provider can make a diagnosis of aPAP.
  • To learn more about aPAP ClearPath™, the importance of early testing for aPAP, and to order a test kit, please visit www.apapclearpath.com .
  • The Company expects to roll out a healthcare provider disease awareness campaign and GM-CSF autoantibody blood test in Europe next year.

Savara Reports Third Quarter Financial Results and Provides Business Update

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星期四, 十一月 9, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Investment, Disease, Chemistry, Inc., Pulmonology, Research, APAP, Chair, Fine chemical, Savara

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2023 and provided a business update.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2023 and provided a business update.
  • “We remain on track to report top line data from the pivotal, Phase 3 IMPALA-2 trial by the end of the second quarter 2024,” said Matt Pauls, Chair and CEO, Savara.
  • “In parallel, we are working to provide pulmonologists in the U.S. and Europe with a simple, accurate, no-cost, laboratory-based antibody blood test for aPAP.
  • As of September 30, 2023, the Company had cash, cash equivalents and short-term investments of ~$168.3 million and debt of ~$26.3 million.