NYHA

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Retrieved on: 
Mercredi, avril 3, 2024
Cardiorenal syndrome, Congestion, DSR, Brussels Stock Exchange, Liver disease, Associate, RED, Patient, NYHA, Mortality, Cancer, Fluid, Heart failure, European Journal, Diuretic, Overload, Syndrome, Yale University, Pharmaceutical industry

The publication can be accessed here .

Key Points: 
  • The publication can be accessed here .
  • Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
  • Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
  • Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Mercredi, mars 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

Retrieved on: 
Mardi, mars 19, 2024
CSL Vifor, University, Research, Exercise, Classification, Health professional, Risk, Patient, Public, Palpitations, Health care, NYHA, News, Periodic breathing, Cardiovascular Research, Quality of life, Health Canada, Woman, Heart failure, Anemia, Fatigue, Hospital, Dietary supplement

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.

Key Points: 
  • Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.
  • "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency."
  • Iron deficiency affects one in every two hospitalized patients with heart failure5.
  • * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms.

First Patient Randomized in AskBio Phase II Gene Therapy Trial for Congestive Heart Failure

Retrieved on: 
Vendredi, février 16, 2024
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Heart, Gene, NYHA, Doctor of Philosophy, News, Ageing, Cardiomyopathy, CHF, Executive Committee, Heart failure, Safety, Bayer, Patient, Guideline, Disease, Phase, Committee, Pharmaceutical industry

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).

Key Points: 
  • Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
  • “GenePHIT will evaluate the safety and efficacy of AB-1002 in the largest number of patients to date and improve our understanding of gene therapy overall for the treatment of congestive heart failure.
  • “The enrollment of this first patient in the Phase II trial represents the culmination of many years of dedicated research and development in all aspects of cardiac gene therapy for congestive heart failure.
  • AB-1002 is manufactured by Viralgen Vector Core, S.L., a wholly owned and independently operated subsidiary of AskBio.

Impulse Dynamics Completes $136M Financing Round

Retrieved on: 
Mercredi, février 14, 2024
CCM, NYHA, Investment, Quality of life, Trial of the century, AIM, Feedback, Heart failure, Safety, Attention, ICD, CRT, Patient, Guideline, Clinical trial, HF, Heart, EF

The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare.

Key Points: 
  • The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare.
  • This substantial investment reflects investor confidence in, and commitment to, the company’s vision and expansion.
  • “This round of funding will accelerate our business, both commercially and with our pipeline of advanced technology innovation,” said Jason Spees, CEO of Impulse Dynamics.
  • “We are thrilled by the ongoing support from top-tier investment groups for Impulse Dynamics,” said Shlomi Nachman, Chairman of the Board.

First patient randomized in AskBio Phase II gene therapy trial for congestive heart failure

Retrieved on: 
Mardi, février 13, 2024
Heart, Gene, NYHA, Doctor of Philosophy, Triangle Park (Quezon City), News, Ageing, Mass, Cardiomyopathy, CHF, Executive Committee, Heart failure, Safety, Bayer, Patient, Guideline, Disease, Phase, Committee, Pharmaceutical industry

Berlin, Germany and Research Triangle Park, NC, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Not intended for UK Media

Key Points: 
  • Berlin, Germany and Research Triangle Park, NC, USA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Not intended for UK Media
    Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
  • “GenePHIT will evaluate the safety and efficacy of AB-1002 in the largest number of patients to date and improve our understanding of gene therapy overall for the treatment of congestive heart failure.
  • “The enrollment of this first patient in the Phase II trial represents the culmination of many years of dedicated research and development in all aspects of cardiac gene therapy for congestive heart failure.
  • AB-1002 is manufactured by Viralgen Vector Core, S.L., a wholly owned and independently operated subsidiary of AskBio.

Edwards’ EVOQUE Valve Replacement System First Transcatheter Therapy to Earn FDA Approval for Tricuspid Valve

Retrieved on: 
Vendredi, février 2, 2024
Science, Cardiology, Research, Surgery, Health, FDA, Medical Devices, Clinical Trials, Multimedia, NYHA, Mortality, Tricuspid regurgitation, Hospital, MD, TCT, Food and Drug Administration, Edwards Lifesciences, Patient, Columbia University, Food, CE marking, Quality of life, Risk, Tricuspid valve, KCCQ, OMT

Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).

Key Points: 
  • Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR).
  • The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team.
  • “The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients.
  • The EVOQUE system received CE Mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to receive regulatory approval to treat TR.

Liquidia Corporation Provides Update on New Drug Application for YUTREPIA™ (treprostinil) inhalation powder

Retrieved on: 
Jeudi, janvier 25, 2024
United Therapeutics, CAFC, Patient, PAH, Patent, Originality, NYHA, District court, Functional, Food, NDA, Safety, Orthostatic hypertension, FDA, PTAB, New Drug Application, Exercise, PDUFA, UTHR, Pulmonary hypertension

The FDA informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA.

Key Points: 
  • The FDA informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA.
  • The FDA did not request any additional clinical data to support the NDA and did not issue a new PDUFA goal date.
  • As communicated by the tentative approval to treat PAH, YUTREPIA has already met the regulatory standards for quality, safety and efficacy.
  • In July 2023, Liquidia filed an amendment to its New Drug Application for YUTREPIA, seeking to add PH-ILD to the label.

AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure (CHF)

Retrieved on: 
Vendredi, janvier 5, 2024
Guideline, Entrepreneurship, Heart, Learning, Bayer, Cardiomyopathy, Hope, Triangle Park (Quezon City), NYHA, MD, Doctor of Philosophy, Gene, CHF, Patient, Safety, NCT, Heart failure, Pharmaceutical industry

GenePHIT will include between 90 and 150 adults with left ventricle ejection fraction between 15 and 35%, who continue to suffer from heart failure symptoms despite guideline recommended therapy.

Key Points: 
  • GenePHIT will include between 90 and 150 adults with left ventricle ejection fraction between 15 and 35%, who continue to suffer from heart failure symptoms despite guideline recommended therapy.
  • Our hope is that one day AB-1002 will potentially help patients suffering from congestive heart failure.”
    The GenePHIT trial, which includes 52-week safety and primary efficacy and four-year long-term follow-up periods, is currently recruiting.
  • AskBio plans to conduct the trial in the U.S. and multiple countries in Europe.1 For more information, please visit clinicaltrials.gov ( NCT#05598333 ) or visit askbio.com .
  • AB-1002 is manufactured by Viralgen Vector Core, a wholly owned and independently operated subsidiary of AskBio.

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Retrieved on: 
Vendredi, janvier 5, 2024
Cordella, Food, FDA, NYHA, News, IDE, GDMT, Congestion, Patient, HF, Heart failure, PMA, Vital signs, Pharmaceutical industry

NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).
  • Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home.
  • "Submitting this PMA application is a significant regulatory milestone and brings us one step closer to the expected commercial launch of the Cordella Sensor in the second half of this year."
  • This news follows the company's prior announcement that PROACTIVE-HF, the company's 450-patient investigational device exemption (IDE) trial, completed enrollment .