APAP

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

Retrieved on: 
Monday, April 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)

Retrieved on: 
Wednesday, April 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

Retrieved on: 
Tuesday, March 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: 
Friday, March 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

Retrieved on: 
Thursday, March 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)

Retrieved on: 
Thursday, December 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

Retrieved on: 
Thursday, November 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.

Terns Pharmaceuticals Highlights New Preclinical Data for TERN-601 Program in Obesity at the ADA’s 83rd Annual Scientific Session and Upcoming Events

Retrieved on: 
Monday, June 26, 2023
Obesity, Food, NASH, Clinical trial, Paracetamol, Piper Sandler Companies, Plasma, Blood, American Diabetes Association, Fireside, Fatty liver disease, Tern, Webcast, Mouse, APAP, ADA, Glucose tolerance test, Trapping, Pharmaceutical industry

FOSTER CITY, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, today announced that new preclinical data from a transgenic mouse model evaluating TERN-601, the Company’s novel oral GLP-1R agonist, were highlighted in a poster presentation at the American Diabetes Association’s 83rd Annual Scientific Sessions, which took place from June 23-26, 2023 in San Diego.

Key Points: 
  • Food intake was also recorded for 24 hours in fasted mice treated with TERN-601, with food available 15 minutes post dose.
  • Piper Sandler Inaugural Obesity Investor Day:
    The Piper Sandler event webcast link is available from Piper Sandler and will require registration.
  • A webcast of Terns’ obesity event will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com.
  • A replay of the webcast will be archived on Terns’ website for at least 30 days following the presentation.

Savara Completes Enrollment of Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Retrieved on: 
Monday, June 26, 2023
Health, FDA, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, APAP, The New England Journal of Medicine, Inc., Food, COVID-19, IMPALA, MHRA, Patient, PIM, Medicines and Healthcare products Regulatory Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Chair, Pharmaceutical industry

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial.
  • Target enrollment for the trial was 160 patients.
  • IMPALA-2 is a global, 48-week, placebo-controlled clinical trial evaluating molgramostim, a novel inhaled biologic, for the treatment of aPAP, a rare lung disease with no approved pharmacological treatments.
  • “Enrollment completion marks an important milestone in the molgramostim development program,” said Matt Pauls, Chair and CEO, Savara.

Global Analgesics Market Report 2023: Sector is Expected to Reach $67.4 Billion by 2028 at a CAGR of 4.49% - ResearchAndMarkets.com

Retrieved on: 
Monday, April 24, 2023
Health, Pharmaceutical, Organic acid, Oxycodone, Analgesic, USFDA, Pain, APAP, Morphine, Inflammation, Paracetamol, Consciousness, Nonsteroidal anti-inflammatory drug, Pharmaceutical industry

Analgesics are used for treating pain resulting from physiological injuries, surgeries, phantom aches, inflammation, neuropathic conditions and cancer treatments.

Key Points: 
  • Analgesics are used for treating pain resulting from physiological injuries, surgeries, phantom aches, inflammation, neuropathic conditions and cancer treatments.
  • However, by 2050, these numbers are expected to reach 2100 million, accounting for around 21% of the total global population.
  • The publisher provides an analysis of the key trends in each sub-segment of the global analgesics market report, along with forecasts at the global and regional level from 2023-2028.
  • Our report has categorized the market based on type, drug class, route of administration, pain type and application.