Catecholamine

Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research

Retrieved on: 
Thursday, February 1, 2024

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.

Key Points: 
  • The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.
  • SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias.
  • Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients.
  • Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock.

Windtree Therapeutics Announces Reduction In Arrythmias In A New Study With Istaroxime And A Pure SERCA2a Activator

Retrieved on: 
Tuesday, January 2, 2024

WARRINGTON, Pa., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced new preclinical data on the Company’s lead product candidate, istaroxime, and another preclinical pipeline drug candidate, CVie-216, showing reductions in ventricular arrythmias in a rat heart model of diabetes with restricted and restored coronary blood flow induced injury. Istaroxime and CVie-216 are each designed to act on pumps in the cardiac cells that are important in calcium handling. Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a. CVie-216 is designed to selectively activate SERCA2a.

Key Points: 
  • Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a.
  • Nearly 300 patients with acute decompensated heart failure were treated with istaroxime in three Phase 2 studies, including a study that evaluated patients with early cardiogenic shock.
  • Windtree is continuing to obtain data to evaluate the potential benefits of SERCA2a activation on arrythmia risk in all ongoing clinical trials.
  • This study demonstrated a reduction in arrythmias in the istaroxime and CVie-216 pretreated groups compared to the control group.

Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)

Retrieved on: 
Thursday, December 7, 2023

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.
  • Carbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s.
  • ONGENTYS® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time.
  • The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance.

Incheon National University Scientists Develop New Hydrogels for Wound Management

Retrieved on: 
Monday, November 6, 2023

GWANGJU, South Korea, Nov. 6, 2023 /PRNewswire/ -- Wound management is essential to ensure a speedy and safe recovery, and tissue adhesive patches are an attractive option that can replace sutures and stapling. In a recent study, researchers from Korea developed a new type of gelatin-based tissue adhesive hydrogel that locally generates oxygen through a reaction mediated by calcium peroxide, which improves the adhesiveness of the material and greatly enhances the healing process.

Key Points: 
  • Open wounds, whether caused by accidents or from medical procedures like surgery, require proper management to speed up healing and prevent infections.
  • While sutures and staples are common wound closure methods, they can cause secondary tissue injuries, potentially leaking fluids and gases and requiring anesthetics.
  • Against this backdrop, a team of researchers from Korea, led by Associate Professor Kyung Min Park of Incheon National University set out to find an effective solution to these limitations.
  • The research team has high hopes for the potential of the GOTs to become a cost-effective solution for wound management in a clinical setting.

Fresenius Kabi Launches Vasopressin Injection, USP Expanding U.S. Critical Care Portfolio

Retrieved on: 
Wednesday, June 14, 2023

Fresenius Kabi announced today the availability in the United States of Vasopressin Injection, USP, a generic equivalent to Vasostrict®.

Key Points: 
  • Fresenius Kabi announced today the availability in the United States of Vasopressin Injection, USP, a generic equivalent to Vasostrict®.
  • Fresenius Kabi Vasopressin Injection, USP is an approved treatment option for adults with vasodilatory shock and is available in a 20 Units per 1 mL Single Dose Vial.
  • Fresenius Kabi produces Vasopressin Injection, USP in the United States where the company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems.
  • To learn more about how Fresenius Kabi is strengthening America’s supply chain of care, please visit “ More in America .”
    Please see Important Safety Information below.

EQS-News: PAION IS HOSTING A SPONSORED ANGIOTENSIN II SYMPOSIUM AT ISICEM IN BRUSSELS

Retrieved on: 
Thursday, March 16, 2023

One abstract about angiotensin II has been accepted for a presentation.

Key Points: 
  • One abstract about angiotensin II has been accepted for a presentation.
  • In addition, PAION has organised a Sponsored Symposium.
  • Poster number P219
    This post hoc analysis helps to understand which group of patients might be further studied to determine benefits from treatment with angiotensin II.
  • Angiotensin II mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure.

Vistagen Receives FDA Fast Track Designation for Development of PH10 to Treat Major Depressive Disorder

Retrieved on: 
Tuesday, December 6, 2022

Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression.

Key Points: 
  • Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression.
  • The FDAs grant of the Fast Track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need.
  • We look forward to working with the FDAs Fast Track program as we advance development of PH10 in the United States.

Evoke Pharma Strengthens its Intellectual Property Portfolio with a Notice of Allowance from the USPTO for a Patent Application Related to GIMOTI®

Retrieved on: 
Wednesday, November 30, 2022

This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.

Key Points: 
  • This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.
  • We are thrilled and highly encouraged by the strides we have made with the USPTO and its continued acknowledgement of the novel and inventive nature of GIMOTI, said Matt DOnofrio, Chief Business Officer of Evoke Pharma.
  • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.
  • Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects.

Vistagen Receives FDA “Study May Proceed” Letter Under its Investigational New Drug Application for PH10 to Treat Major Depressive Disorder

Retrieved on: 
Wednesday, November 30, 2022

Phase 1 clinical trial under Vistagens newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD).

Key Points: 
  • Phase 1 clinical trial under Vistagens newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD).
  • People living with major depressive disorder urgently need new and differentiated therapies we are committed to addressing that need.
  • The FDAs clearance to advance our clinical program for PH10 in the U.S. is another important milestone for our company, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.