Pulmonary hypertension

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Blood pressure, Diagnosis, Tadalafil, Blood, Serotonin, Patient, Committee, Knowledge, Regulation, Prostacyclin, EMA, IRIS, Artery, Life expectancy, Heart failure, Orthostatic hypertension, European, Therapy, COMP, Heart, Safety, European Commission, Marketing, Pulmonary hypertension, Medicine, Pharmaceutical industry

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Key Points: 


Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Diagonal Therapeutics Launches with $128 Million in Financing to Pioneer a New Approach to Discovering and Developing Agonist Antibodies to Tackle the Underlying Causes of Severely Debilitating Diseases

Retrieved on: 
Wednesday, April 3, 2024
Hereditary hemorrhagic telangiectasia, Telangiectasia, Biotechnology, Blood, Disease, Atlas, Patient, Lung, Stroke, Viking Global Investors, Death, Artery, Chiari malformation, Rupture, Intraparenchymal hemorrhage, Heart failure, Lightspeed Venture Partners, Therapy, TGF, Antibody, Bleeding, Heart, Pharmacology, Unified school district, HHT, PAH, Atlas Venture, Pulmonary hypertension, Pharmaceutical industry

CAMBRIDGE, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Diagonal Therapeutics, a biotechnology company pioneering a new approach to discovering and developing agonist antibodies, launched today with $128 million in financing. The Series A was co-led by BVF Partners and Atlas Venture, with participation from Lightspeed Venture Partners, RA Capital Management, Frazier Life Sciences, Viking Global Investors, Velosity Capital, and Checkpoint Capital. Diagonal was co-founded by Chief Executive Officer, Alex Lugovskoy, Ph.D., and Atlas and previously seeded by Atlas, Lightspeed Venture Partners, and Velosity Capital. The financing will support further advancement of the company’s proprietary DIAGONAL platform and pipeline of novel therapeutics to value-creating milestones, including its lead program for the treatment of hereditary hemorrhagic telangiectasia (HHT), a severely debilitating bleeding disorder with limited therapeutic options, through clinical proof-of-concept. Diagonal's agonist antibody activates a receptor complex in the TGF-β superfamily genetically impaired in HHT patients. In preclinical models of HHT, Diagonal's agonist antibodies prevent and reverse the formation of pathological vascular malformations.

Key Points: 
  • Diagonal was co-founded by Alex Lugovskoy, Ph.D., and Atlas and previously seeded by Atlas, Lightspeed Venture Partners, and Velosity Capital.
  • CAMBRIDGE, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Diagonal Therapeutics, a biotechnology company pioneering a new approach to discovering and developing agonist antibodies, launched today with $128 million in financing.
  • Diagonal was co-founded by Chief Executive Officer, Alex Lugovskoy, Ph.D., and Atlas and previously seeded by Atlas, Lightspeed Venture Partners, and Velosity Capital.
  • In preclinical models of HHT, Diagonal's agonist antibodies prevent and reverse the formation of pathological vascular malformations.

Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension

Retrieved on: 
Wednesday, April 3, 2024
Ventricular septal defect, DCN, Disease, HIV, Patient, CTD, Connective tissue disease, Death, Parkinson's disease, Imatinib, IND, Pulmonary hypertension, Woman, Therapy, Heart, Safety, Division, WHO, HIV/AIDS, Stomach, PAH, FDA, Blood, Food, Pharmaceutical industry

The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.

Key Points: 
  • The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.
  • “Following our pre-NDA discussion with the FDA related to the path to approval for IkT-001Pro in up to 11 blood and stomach cancers in January, we requested an additional FDA meeting with the Division of Cardiology and Nephrology to discuss Pro as a treatment for Pulmonary Arterial Hypertension,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase.
  • “PAH is a rare condition that primarily afflicts women between the ages of 30 and 60 and can lead to premature heart failure and death.
  • We believe that Pro may be a be a safer and better tolerated therapeutic option for imatinib treatment in PAH.

Update on Favorable Legal and Regulatory Outcomes Clearing Path for Potential FDA approval of YUTREPIA™ (treprostinil) inhalation powder

Retrieved on: 
Monday, April 1, 2024
UTHR, District court, Pulmonary hypertension, United Therapeutics, NDA, Motion, Originality, Orthostatic hypertension, Therapy, Patent, PAH, FDA, Court, Hearing, Food

As a result, the U.S. Food and Drug Administration (FDA) is no longer enjoined from issuing final approval of Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.

Key Points: 
  • As a result, the U.S. Food and Drug Administration (FDA) is no longer enjoined from issuing final approval of Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.
  • We have submitted the judge’s order to the FDA and look forward to a decision from the FDA in the near future.
  • Our commercial team is fully prepared to launch YUTREPIA in both PAH and PH-ILD should the FDA grant final approval.
  • The FDA is now able to take final action on YUTREPIA’s amended NDA that seeks approval for both indications.

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Q&A, Exercise, Patient, Pulmonary hypertension, Cardiovascular Research, Clinical trial, IP, Therapy, LINK, Research, Science, LEVEL, Public expenditure, Heart failure, Development, Tenax, Disease, KOL, TNX-102, First, Research and development, MPH, Cardiology, Conference, Patent, Doctor of Philosophy, Faculty, MBA, Levosimendan, THT, Feinberg School of Medicine, Pharmaceutical industry

We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
  • LINK TO REGISTER
    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.

CorVista Health to Present New Data on the Use of Machine Learning as a Non-Invasive Point-of-Care Rule-out Test for Heart Failure at ACC 2024

Retrieved on: 
Sunday, April 7, 2024
Technology, Medical Devices, Surgery, Health Technology, Cardiology, Software, Other Health, General Health, Health, Artificial Intelligence, Diagnosis, TTE, Machine learning, Cardiovascular disease, Coronary artery disease, Pulmonary hypertension, Patient, Heart, Heart failure, American College, Data collection, FDA, CAD

The CorVista System is the world’s first non-invasive point-of-care solution for evaluating the presence of coronary artery disease and pulmonary hypertension.

Key Points: 
  • The CorVista System is the world’s first non-invasive point-of-care solution for evaluating the presence of coronary artery disease and pulmonary hypertension.
  • Timely identification of left ventricular dysfunction plays a pivotal role in effective heart failure management, however, measuring elevated LVEDP currently relies on invasive left heart catheterization.
  • Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health.
  • “We believe the CorVista System can uniquely and effectively address these important unmet needs for people living with cardiovascular disease, especially in rural and underserved populations.”

Wayne J. Franklin, M.D., F.A.C.C., named senior vice president of the Children’s National Heart Center

Retrieved on: 
Wednesday, March 13, 2024
Internal medicine, Obstetrics, Ventricular septal defect, Gynaecology, Cardiology, Pediatric nursing, Education, Pulmonary hypertension, Patient, Duke University, SVP, Research, Electrophysiology, University, Pregnancy, Quality, Pediatrics, Hospital, Safety, Division, Children's National Hospital, Baylor University, Williams College

Washington, D.C., March 13, 2024 (GLOBE NEWSWIRE) -- Children's National Hospital has appointed Wayne J. Franklin, M.D., F.A.C.C., as the new senior vice president (SVP) of the Children’s National Heart Center .

Key Points: 
  • Washington, D.C., March 13, 2024 (GLOBE NEWSWIRE) -- Children's National Hospital has appointed Wayne J. Franklin, M.D., F.A.C.C., as the new senior vice president (SVP) of the Children’s National Heart Center .
  • Dr. Franklin currently serves as co-director, medical director of Quality and endowed chair in the Center for Heart Care and associate director of the Adult Congenital Heart Disease Program at Phoenix Children’s.
  • “I look forward to leading the exceptional Heart Center team at Children’s National, as we contribute to advancing pediatric cardiac care and research,” said Dr. Franklin.
  • “Together with our Heart Center leadership team, he will ensure we’re meeting the highest standards of safety, quality and innovative care for our patients and families.”
    The Children’s National Heart Center is a multidisciplinary center that provides high-quality and innovative pediatric cardiac care.

Liquidia Corporation Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 13, 2024
Research, PRINT, SVB, Patient, Pulmonary hypertension, Sale, NDA, PTAB, Orthostatic hypertension, Promotion, Safety, Security, PAH, FDA, Food, Cryptocurrency

ET

Key Points: 
  • ET
    MORRISVILLE, N.C., March 13, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the full year ended December 31, 2023.
  • ET to discuss the 2023 financial results and provide a corporate update.
  • In December 2023, the previous ruling by the Patent Trial and Appeal Board (PTAB) that all of the claims in U.S. Patent No.
  • The year ended December 31, 2023 included a $2.3 million loss on extinguishment of debt related to repayment of the A&R SVB LSA in January 2023.

Breakthrough Designated CorVista® System with Pulmonary Hypertension Add-On Cleared by FDA; Enabling Advanced Cardiovascular Testing at Point-of-Care

Retrieved on: 
Friday, April 5, 2024
Software, Research, General Health, Consumer, Technology, Other Communications, Other Consumer, Science, Cardiology, Communications, FDA, Health, Diagnosis, Blood, Coronary artery disease, Pulmonary hypertension, Patient, Life, Mortality, Standard of care, University, External carotid artery, Heart failure, Heart, Analytics, Machine learning, Multimedia, CAD, NPV, Pharmaceutical industry

Analytics for Life, Inc. and CorVista Health Inc. announced the FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module.

Key Points: 
  • Analytics for Life, Inc. and CorVista Health Inc. announced the FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module.
  • The CorVista® System is the first FDA-cleared, machine learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP), an indicator of pulmonary hypertension (PH).
  • The non-invasive CorVista System was recently cleared for use in evaluating the presence of significant coronary artery disease.
  • In 2022 the FDA designated the CorVista System with PH Add-On as a Breakthrough Device for its potential to improve the diagnosis of PH.

Bioelectronic medicine Feinstein Institutes researchers elected to AIMBE College of Fellows

Retrieved on: 
Monday, March 25, 2024
Health, Health Insurance, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Vagus nerve, Metabolism, Interdisciplinarity, Biomedical engineering, Brain, Sepsis, Rheumatoid arthritis, Medicine, Mevalonate pathway, Interface (computing), Communication, International Society, Disease, Paralysis, Diabetes, Education, Inflammation, Pulmonary hypertension, Nervous system, Class, PNAS, Cancer, Neuroscience, Doctor of Philosophy, AIMBE, Neuron, Inflammatory Bowel Diseases, Arthritis, Credit, Northwell Health, American Institute, Molecular medicine, Sensation, Infection, DRS, Immune system, Injury, Medical research, Inflammatory bowel disease, Biology, Multimedia, National academy, Government, ISAN, Medical device

The American Institute for Medical and Biological Engineering (AIMBE) has announced the election of two researchers from The Feinstein Institutes for Medical Research to the AIMBE College of Fellows Class of 2024 for their contributions to the fields of medical and biological engineering, and particularly the field of bioelectronic medicine.

Key Points: 
  • The American Institute for Medical and Biological Engineering (AIMBE) has announced the election of two researchers from The Feinstein Institutes for Medical Research to the AIMBE College of Fellows Class of 2024 for their contributions to the fields of medical and biological engineering, and particularly the field of bioelectronic medicine.
  • Valentin Pavlov, PhD , and Sangeeta Chavan, PhD , both professors in the Institute of Bioelectronic Medicine , were recognized in-person during the AIMBE Annual Event in Washington D.C..
  • Sangeeta Chavan (left) and Valentin Pavlov (right) have been elected to the AIMBE College of Fellows for advancing the fields of medical and biological engineering.
  • On behalf of the Feinstein Institutes and Northwell Health, we congratulate them.”
    The Feinstein Institutes for Medical Research is the global scientific home of bioelectronic medicine where medical researchers use modern technology to develop new device-based therapies to treat disease and injury.