Thrombosis

First-Ever Cost-Effectiveness Analysis of a Factor XI Inhibitor Demonstrates that Abelacimab, if Approved, Could Offer Significant Cost Savings as Compared to a Current Standard of Care Anticoagulant

Retrieved on: 
måndag, maj 6, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, USD, Anticoagulant, Hemostasis, Stroke, TIMI, Anthos, Risk, DOAC, MD, Doctor of Philosophy, Pharmacist, AZALEA, Patient, Professional, Atrial fibrillation, Therapy, Life imprisonment, Thrombosis, Rivaroxaban, Pharmaceutical industry

Results of the first-ever cost-effectiveness study of a Factor XI inhibitor were presented today during sessions of the Professional Society for Health Economics and Outcomes Research (ISPOR) annual meeting.

Key Points: 
  • Results of the first-ever cost-effectiveness study of a Factor XI inhibitor were presented today during sessions of the Professional Society for Health Economics and Outcomes Research (ISPOR) annual meeting.
  • The analysis indicates that abelacimab could offer a potential cost-savings of $50,000 USD and improvements of 1.5 quality-adjusted life years (QALY’s) per person over a lifetime horizon as compared to rivaroxaban, a commonly used direct oral anticoagulant (DOAC).
  • If approved by US regulatory authorities, abelacimab could be a highly cost-effective anticoagulant option.
  • The great promise of a factor XI inhibitor such as abelacimab, rests largely with the ability to prevent thrombosis with minimal disruption of hemostasis.

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®, the First VWF Concentrate for Prophylaxis in All Types of VWD

Retrieved on: 
måndag, april 29, 2024
FDA, Haemophilia, Patient, Bleeding, News, Hospital, Food, Therapy, Von Willebrand disease, Disease, Caregiver, Thrombosis, Health, Coagulopathy, The O'Reilly Factor, VWD, Inherit, Quality of life, VWF, Pharmaceutical industry

Patients with severe VWD are recommended to utilize long-term prophylaxis with VWF concentrate.

Key Points: 
  • Patients with severe VWD are recommended to utilize long-term prophylaxis with VWF concentrate.
  • The FDA Orphan Drug Designation program provides orphan status to biologics and drugs for rare diseases.
  • "The FDA orphan exclusivity is exciting news for Octapharma and patients who have endured excessive bleeding episodes," said Octapharma USA President Flemming Nielsen.
  • The Factor My Way patient support program is designed by Octapharma USA for those living with VWD and hemophilia A.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
onsdag, april 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), 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 that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Anthos Therapeutics Announces Appointment of Bill Meury as CEO

Retrieved on: 
måndag, april 22, 2024
University, Cancer, Bleeding, AbbVie, Economics, Marketing, Forest Laboratories, Actavis, Factor XI, Senior, Patient, BMS, Bristol Myers Squibb, Atrial fibrillation, Therapy, Thrombosis, Pharmaceutical industry

CAMBRIDGE, Mass., April 22, 2024 (GLOBE NEWSWIRE) -- Anthos Therapeutics, Inc. (Anthos), is a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today announced the appointment of Bill Meury as CEO and member of the board of directors.

Key Points: 
  • CAMBRIDGE, Mass., April 22, 2024 (GLOBE NEWSWIRE) -- Anthos Therapeutics, Inc. (Anthos), is a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today announced the appointment of Bill Meury as CEO and member of the board of directors.
  • Meury joins after successfully leading Karuna Therapeutics (Karuna), which was recently acquired by Bristol Myers Squibb (BMS).
  • Meury will succeed founding CEO John Glasspool, who will join Blackstone Life Sciences as an Operating Advisor.
  • Abelacimab has the potential to be a game-changing treatment for patients.”
    Paris Panayiotopoulos, Anthos Board Member and Senior Managing Director of Blackstone Life Sciences, said: “I am very excited that Bill has agreed to join Anthos as its next CEO.

RenovoRx Highlights Recent Presentation of Clinical Data Abstract at the 2024 Society of Interventional Radiology Annual Scientific Meeting

Retrieved on: 
tisdag, april 16, 2024
Research, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, MVT, Sale, FDA, Pain, Interventional radiology, Patient, Phase, Risk, Ischemia, Pancreatic cancer, Prevalence, Thrombosis, LAPC, Radiology, MD, Venous thrombosis, Columbia University, Society of Interventional Radiology, Vein, SIR, Associate, TAMP, Coronary thrombosis, Medical imaging

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlights a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today highlights a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah.
  • Clinical data was presented by David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center in New York.
  • The data presentation highlighted that of the 25 patients randomized to the TAMP therapy, 6 failed to complete all 8 planned procedures due to thrombosis of the targeted arterial artery.
  • The first interim analysis in the Phase III TIGeR-PaC study was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study.

Annoviant™ Awarded $2.99 Million NIH Grant to Advance TxGuard™ Pulmonary-Valved Conduit for Pediatric Heart Disease

Retrieved on: 
tisdag, april 16, 2024
Phase, Bangladesh Technical Education Board, NIH, Infection, Heart, Research, CHD, Entrepreneurship, Ventricular septal defect, Patient, Birth defect, Calcification, MBA, SBIR, Thrombosis, Pharmaceutical industry

This grant aims to propel the development and commercialization of its revolutionary TxGuard™ pulmonary valved conduit.

Key Points: 
  • This grant aims to propel the development and commercialization of its revolutionary TxGuard™ pulmonary valved conduit.
  • Building upon the Phase II NIH Grant secured in 2021, this funding represents a significant step forward in Annoviant's mission to transform the landscape of pediatric cardiac care.
  • Patented TxGuard™ stands at the forefront of technological innovation in conduit replacements for treating CHD.
  • With NIH Phase IIb funding, we look forward to further refining pulmonary valved conduits for the benefit of CHD patients."

Dr. Goodyear, Integrative Cancer Expert, Observes Benefits When Using CBD IV Therapy by Pico IV with Oncology Patients

Retrieved on: 
onsdag, april 10, 2024
Pain, Brain, Jarisch–Herxheimer reaction, Blood pressure, Nausea, Diabetes, Bone metastasis, Embolism, Depression, Seizure, Obesity, Blood, Patient, Liver, Headache, Hypertension, Chills, Infection, Cannabidiol, Thrombosis, Fever, Anxiety, Medical device

SCOTTSDALE, Ariz., April 10, 2024 /PRNewswire/ -- Medical director of an integrative oncology center in Scottsdale, AZ, Nathan Goodyear, MD, MD(H), began using CBD IV Therapy by Pico IV over four months ago with cancer patients under his care.

Key Points: 
  • SCOTTSDALE, Ariz., April 10, 2024 /PRNewswire/ -- Medical director of an integrative oncology center in Scottsdale, AZ, Nathan Goodyear, MD, MD(H), began using CBD IV Therapy by Pico IV over four months ago with cancer patients under his care.
  • He found that CBD IV therapy was well-tolerated by almost all patients, with only two experiencing a Jarisch-Herxheimer reaction due to undiagnosed port infections.
  • Pico IV are the makers of the world's first CBD IV therapy.
  • Joe Young, CEO of Pico IV Inc, shared "When we first launched CBD IV Therapy, we were excited about the potential benefits for users.

EQS-News: TVM CAPITAL LIFE SCIENCE TO PARTICIPATE IN LSI USA ’24 EMERGING MEDTECH SUMMIT 2024

Retrieved on: 
onsdag, april 10, 2024
Radiation, Thrombosis, Partner (business rank), Infection, Intelligence, TVM, Risk, General partnership, Patient, Eye injury, Standard of care, AI, Workflow, Investment, LSI, Phlebitis, Eli Lilly and Company, Vector, Therapy, FDA, Physician, Health, PFC, Medical imaging

Munich, Germany and Montreal, Quebec, Canada (March 13, 2024) – TVM Capital Life Science (“TVM”), a leading international venture capital firm focused on investments in life sciences innovation, today announced that the Company will participate in the sixth annual LSI USA ’24 Emerging Medtech Summit 2024, which brings together leading innovators, active investors and committed strategics from the medtech industry to partner and build next-generation healthcare technologies.

Key Points: 
  • Munich, Germany and Montreal, Quebec, Canada (March 13, 2024) – TVM Capital Life Science (“TVM”), a leading international venture capital firm focused on investments in life sciences innovation, today announced that the Company will participate in the sixth annual LSI USA ’24 Emerging Medtech Summit 2024, which brings together leading innovators, active investors and committed strategics from the medtech industry to partner and build next-generation healthcare technologies.
  • The conference will take place March 18-22, 2024, in Dana Point, California, USA.
  • "Medtech innovation continues to be at the forefront of healthcare advancement, driving transformative changes in patient care, operational efficiency and cost reduction.
  • As part of our commercial-stage medical technologies investment strategy, TVM seeks breakthrough solutions that align with emerging trends and could redefine the standard of care.

Cadrenal Therapeutics Receives FDA Orphan Drug Designation for Tecarfarin for Prevention of Thromboembolism and Thrombosis in Patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts

Retrieved on: 
tisdag, april 9, 2024
ODD, Warfarin, Thrombosis, VADS, Risk, Vitamin K antagonist, New Drug Application, Patient, Apixaban, Stroke, Anticoagulant, Splenic infarction, Death, Therapy, Bleeding, LVAD, FDA, VKA, Pharmaceutical industry

PONTE VEDRA, Fla., April 9, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, announced today that the United States Food and Drug Administration (FDA) has granted tecarfarin Orphan Drug Designation (ODD) for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device (left ventricular assist device (LVAD), right ventricular assist device (RVAD), collectively known as ventricular assist devices (VADs), biventricular assist device, and total artificial heart).

Key Points: 
  • "This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate," said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.
  • "We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible."
  • Since its adoption in 1983, the Orphan Drug Act has helped countless individuals living with these conditions gain access to life-enhancing and life-saving therapies.
  • The designation is made to promote safe and efficacious products for the treatment of rare conditions.

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

Retrieved on: 
onsdag, 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.