Lung transplantation

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, TFF, Administration, Conference, Patient, IPA, EAP, Mortality, G&A, Lung transplantation, Insurance, AAAM, Microsoft Access, Research and development, Infection, Safety, FDA, Heart, Corporation, Pharmaceutical industry

FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.
  • For TFF TAC, the Company presented data showing that eight out of eight patients successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • In the fourth quarter 2023, the Company announced the appointment of three new members of its Board of Directors, including Thomas B.

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

Retrieved on: 
Wednesday, March 27, 2024
Principal, Annual, Fungal infection, TFF, COVID, Intubation, International Society, Part, Patient, Biomarker, IPA, Spirometry, EAP, Mortality, Lung transplantation, Microsoft Access, Potential, Safety, Kidney, Heart, Pharmaceutical industry

FORT WORTH, Texas , March 27, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Key Points: 
  • “Based on the totality of these clinical data, we believe TFF TAC and TFF VORI have the potential to establish a new and significantly improved form of delivery for these two life-saving medicines.
  • The updated safety and efficacy data are based on the cutoff date of March 8, 2024.
  • The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity.
  • The Company will host a conference call today at 4:30 pm Eastern Time, to discuss updated data for the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

CareDx and Collaborators Present Latest Cardiothoracic Advancements at the 2024 International Society for Heart and Lung Transplantation Meeting

Retrieved on: 
Tuesday, April 9, 2024
Health, Surgery, Genetics, Managed Care, General Health, Cardiology, Biotechnology, Patient, International Society, Caregiver, White, Transplant, Columbia University, University, University of Colorado, Lung transplantation, Heart transplantation, Abstract, Lung, Heart, NYU Langone Health, Stanford University, University Health Network, MAS, Loyola University, Medical device

CareDx, along with study collaborators from leading transplant centers, will present cutting-edge developments that underscore the clinical significance of CareDx’s cardiothoracic portfolio.

Key Points: 
  • CareDx, along with study collaborators from leading transplant centers, will present cutting-edge developments that underscore the clinical significance of CareDx’s cardiothoracic portfolio.
  • This includes AlloSure Heart, AlloMap Heart, HeartCare, AlloSure Lung, and AiCAV (in development); featured in over 25 oral presentations, posters, and two symposia.
  • These presentations will highlight real-world applications driving advancements in heart and lung transplantation.
  • “We are proud to have a leading presence once again at this pivotal heart and lung transplant meeting.

Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera™ Heart dd-cfDNA Test for Heart Transplant Recipients

Retrieved on: 
Monday, April 8, 2024
Research, Surgery, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, General Health, Science, Biopsy, Reward, Plasma, International Society, Cohort (statistics), Physician, Risk, AUC, Nucleic acid thermodynamics, Patient, Journal, DNA, Lung transplantation, Heart transplantation, MD, NIH, NTRA, Hospital, Molecule, Bangladesh Technical Education Board, Medicare, Oportunidades, Annual general meeting, NPV

“We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera.

Key Points: 
  • “We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera.
  • That study showed the Prospera Heart test had an overall area under the curve (AUC) of 0.86 for identifying acute rejection in over 800 samples from 200 adults with heart transplants.
  • The DTRT-2 (DNA-Based Transplant Rejection Test) study, published recently in Pediatric Transplantation , was sponsored by the National Institutes of Health (NIH).
  • A total of 487 samples from 160 heart transplant recipients were evaluated, of which 78 were pediatric and 82 were adult patients.

Valeos Welcomes Dr. Stuart Sweet to Board of Directors

Retrieved on: 
Tuesday, April 9, 2024
American Express, Advisory Committee, Transplant, Organ transplantation, St. Louis Children's Hospital, GM, Information technology, Medicine, Entrepreneurship, CPO, Patient, SVP, CISO, Research, Organ, Human services, Doctor of Philosophy, Lung transplantation, MD, Quality of life, Health policy, Former, Hospital, Author, Ecosystem, OPTN, Government, Pediatrics, Dentistry

WASHINGTON, April 9, 2024 /PRNewswire/ -- Valeos, a 501(c)(3) nonprofit organization designed to improve organ transplant outcomes for patients and organ donors through data collaboration, today announced the appointment of Dr. Stuart C. Sweet, MD, PhD to its Board of Directors. Dr. Sweet is the W. McKim Marriott Professor of Pediatrics at Washington University in St. Louis, MO, and served as the 2016-2017 Board President of the Organ Procurement and Transplantation Network (OPTN), the U.S. national transplant system. Dr. Sweet spent more than two decades as the medical director of the pediatric lung transplant program at Washington University School of Medicine in St. Louis and St. Louis Children's Hospital, focusing clinically on pediatric lung transplantation and gaining expertise in organ allocation, clinical outcomes, health policy and the role of information technology in medicine.

Key Points: 
  • "I am honored to join the exceptional team at Valeos and continue my dedication to advancing the U.S. organ transplant system," said Dr. Sweet.
  • "We're excited to welcome Dr. Sweet to our Board of Directors.
  • This announcement follows an exciting year for Valeos, which saw its first appointments to its Board of Directors and Advisory Committee this past January.
  • With the backing of leading figures in healthcare, technology and government, Valeos is committed to building the world's largest de-identified transplant data sandbox.

TFF Pharmaceuticals Announces Oral Presentation of Interim Data from the Phase 2 Study of Tacrolimus Inhalation Powder (TFF TAC) for the Prevention of Lung Transplant Rejection at the 44th Annual International Society for Heart and Lung Transplantation (I

Retrieved on: 
Monday, March 25, 2024
TFF, Immunosuppression, Tacrolimus, Lung transplantation, Phase II, The Alfred Hospital, Heart, Lead, Pharmaceutical industry

FORT WORTH, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of its late-breaking clinical science abstract for oral presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.

Key Points: 
  • FORT WORTH, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the acceptance of its late-breaking clinical science abstract for oral presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.
  • On January 9, 2024, the Company announced that the data from TFF TAC Phase 2 study was accepted as a late-breaking abstract.
  • “Results from the ongoing Phase 2 trial of TFF TAC continue to suggest that targeted, inhalational delivery of tacrolimus has the potential to provide sufficient immunosuppression to avoid acute rejection at diminished systemic exposures compared to oral tacrolimus” said Professor Gregory Snell, Medical Head of Lung Transplant Service at the Alfred Hospital and Lead Principal Investigator of the Phase 2 TFF TAC trial.
  • “Based on interim clinical data, TFF TAC appears to have the potential to provide a meaningful advancement in the delivery of immunosuppression therapy, and I look forward to presenting updated data from the Phase 2 trial at the upcoming ISHLT 2024 meeting.”
    Multicenter Open-Label Tacrolimus Inhalation Powder Trial Evaluating Safety, Tolerability, Efficacy and Pharmacokinetics (pk) in Lung Transplant (ltx)

Paragonix Technologies Announces Nationwide Commercial Availability of FDA-Cleared BAROguard™ Donor Lung Preservation System

Retrieved on: 
Thursday, April 4, 2024
FDA, Health Technology, Health, Medical Devices, Lung, Massachusetts General Hospital, International Society, Transplant, Patient, Duke University Hospital, Research, Standard of care, Lung transplantation, MD, Surgeon, MSC, UCSF Medical Center, Atmosphere, Hospital, UCLA, Heart, UCLA Health, Medical device

Paragonix Technologies, Inc. , a pioneer in organ transplant technologies and procurement services, announces the full commercial launch of its next-generation transport device, the BAROguard™ Donor Lung Preservation System .

Key Points: 
  • Paragonix Technologies, Inc. , a pioneer in organ transplant technologies and procurement services, announces the full commercial launch of its next-generation transport device, the BAROguard™ Donor Lung Preservation System .
  • First-of-its-kind, the novel BAROguard system combines clinically proven hypothermic preservation techniques alongside active airway management control to ensure that donor lungs maintain optimal conditions during transport for maximum protection.
  • Paragonix Technologies received FDA 510(k) clearance for the device in August 2023, and conducted its first-in-human case at Duke University Medical Center in November 2023.
  • “The commercial launch of BAROguard represents a significant breakthrough for the organ transplantation industry,” said Dr. Lisa Anderson, CEO and President of Paragonix Technologies.

Gossamer Bio Announces Appointment of Steven D. Nathan, M.D., and Skye Drynan to its Board of Directors

Retrieved on: 
Tuesday, March 12, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Pulmonary hypertension, Health care, Artificial intelligence, American Thoracic Society, Whitehead Institute, Lung transplantation, Idiopathic pulmonary fibrosis, Medical director, Biomedical Research, Pulmonology, Capital Group Companies, Gossamer, Partnership, American College, Wellesley College, American studies, Commerce, Creative, Medical education, Biomedicine, Latin American studies, International Society, Putnam Investments, MNTN, University, Senior, House, Publication, Portfolio manager, FDA, Internal medicine, Entrepreneurship, Lord Abbett, MIT, Capital, Bloomberg, GOSS, Orthostatic hypertension, IPF, Initial public offering, Partner, Idiopathic disease, PAH, Pharmaceutical industry

Skye Drynan is the Founder, CEO and Creative Director of House of Skye, Ltd., and a former Partner and Senior BioPharma Analyst at Capital Group.

Key Points: 
  • Skye Drynan is the Founder, CEO and Creative Director of House of Skye, Ltd., and a former Partner and Senior BioPharma Analyst at Capital Group.
  • Ms. Drynan joins the Board with an extensive background in finance, investment, and entrepreneurship, specializing in the biotechnology industry.
  • “The addition of Dr. Nathan to our Board signifies a pivotal moment in Gossamer’s evolution,” said Faheem Hasnain, Co-Founder, Chairman and CEO of Gossamer Bio.
  • Ms. Drynan is the Founder, CEO and Creative Director of House of Skye, Ltd., which she founded in 2016.

New International Study Reports Extension of the Donor Lung Transplantation Window

Retrieved on: 
Tuesday, March 12, 2024
FDA, Surgery, Medical Devices, Hospitals, Health, Clinic, Temperature, UZ Leuven, Transplant, Massachusetts General Hospital, Assistant, Motol University Hospital, Risk, Patient, Transport, Lung transplantation, Surgeon, Thorax, Ice, Dentistry

This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation.

Key Points: 
  • This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation.
  • For example, presenting a means to better accommodate longer transportation times, overnight bridging, or optimizing case scheduling during the day.
  • During the six-month study period, the LUNGguard® Donor Lung Preservation System was utilized to preserve donor lungs for over 15 hours in 13 separate instances.
  • Longer ischemic times increase the risk of primary graft dysfunction, a serious complication that can occur after lung transplantation.

Researchers at Phoenix Children's First in the World to Produce Mouse Lungs in Rats

Retrieved on: 
Monday, March 25, 2024
Research, ESC, Bioreactor, B cell, Regeneration, Neurology, Rat, Cell, Osteogenesis imperfecta, Assistant, Cardiology, Critical Care Medicine (journal), Patient, American Journal, DNA, Pharmacist, Manuscript, Cancer, University, Hope, Doctor of Philosophy, Lung transplantation, MD, Biostatistics, Respiratory failure, Cas9, CRISPR, Stem cell, Premature, Research institute, College of Engineering (KNUST), Medicine, Nursing, Animal

PHOENIX, March 25, 2024 /PRNewswire/ -- Research conducted at the Phoenix Children's Research Institute at the University of Arizona College of Medicine — Phoenix reports the successful generation of a mouse lung in a rat, according to a paper published in the American Journal of Respiratory and Critical Care Medicine.

Key Points: 
  • The critical differentiating factor with this study is researchers incorporated CRISPR-Cas9, a unique genome editing technology that allows researchers to change genomes by altering sections of the DNA sequence.
  • Modifications of rat embryos by CRISPR-Cas9 allowed the formation of lung tissues consisting of almost all mouse lung cells.
  • This is one of many recent accolades for the Phoenix Children's Research Institute.
  • The Phoenix Children's Research Institute at the University of Arizona College of Medicine –Phoenix launched in May 2023, formalizing a longstanding research collaboration between the health system and the University of Arizona College of Medicine – Phoenix.