Hemolysis

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)

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星期一, 四月 15, 2024
FDA, Pain, Mortality, Nephrology, Inflammation, Monocyte, Cell, Anemia, Alternative complement pathway, Safety, Ophthalmology, Red blood cell, Food, Hematology, Chelsea Handler, Dermatology, Half-life, Atypical hemolytic uremic syndrome, Blood, AP, Hyperlipidemia, Hemoglobinuria, Disease, Patient, Neurology, Fatigue, Platelet, Diagnosis, Infection, Hemolysis, Immune system, PNH, ODD, Quality of life, Chronic pain, LDH, Paroxysmal nocturnal hemoglobinuria, Pharmaceutical industry

The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.

Key Points: 
  • The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.
  • CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • NM5072 is another drug in our pipeline that has received Orphan Drug Designation in the United States.
  • Among these, Paroxysmal Nocturnal Hemoglobinuria (PNH) emerges as a prominent indication for complement blockers heading towards FDA approval.

BrightSpring Health Services Specialty Pharmacy Onco360® Selected as National Pharmacy Partner for Voydeya®

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星期三, 四月 10, 2024
FDA, Cancer, Pharmacy, Hub, Blood, Eculizumab, Ravulizumab, Insurance, Alexion Pharmaceuticals, Disease, EVH, Patient, Haematopoietic system, Hemolysis, Alexion, Health care, Immune system, PNH, Quality of life, Anemia, Pharmaceutical industry

LOUISVILLE, Ky., April 10, 2024 (GLOBE NEWSWIRE) -- BrightSpring Health Services (“BrightSpring” or “BrightSpring Health Services”) (NASDAQ: BTSG) announced today that its company Onco360®, a leading independent oncology pharmacy, was selected as a national pharmacy partner by Alexion Pharmaceuticals for a first-in-class, oral, Factor D inhibitor, Voydeya® (Danicopan) to treat patients with a rare, life-threatening disease of the blood called paroxysmal nocturnal hemoglobinuria (PNH) who are experiencing extravascular hemolysis (EVH).

Key Points: 
  • LOUISVILLE, Ky., April 10, 2024 (GLOBE NEWSWIRE) -- BrightSpring Health Services (“BrightSpring” or “BrightSpring Health Services”) (NASDAQ: BTSG) announced today that its company Onco360®, a leading independent oncology pharmacy, was selected as a national pharmacy partner by Alexion Pharmaceuticals for a first-in-class, oral, Factor D inhibitor, Voydeya® (Danicopan) to treat patients with a rare, life-threatening disease of the blood called paroxysmal nocturnal hemoglobinuria (PNH) who are experiencing extravascular hemolysis (EVH).
  • Voydeya® is FDA-approved as add-on therapy to Ultomiris® (Ravulizumab) or Soliris® (Eculizumab) for patients living with PNH that experience continued anemia, or EVH.
  • This innovative drug will complement current treatment regimens and help regulate the immune system, providing control and preventing the destruction of healthy blood cells.
  • To learn more about Onco360® and BrightSpring, please visit https://www.brightspringhealth.com/ .

Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results

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星期一, 四月 1, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, PIN, PNH, Patient, Sale, CUD, Graft-versus-host disease, Investment, Clinical trial, Hemolysis, Calcineurin, Emory University, ASH, Risk, L-DOPA, Thumbay Hospital, Behavior informatics, Trial of the century, Myelodysplastic syndrome, Cancer, Safety, Transplant, LID, DRI, BLA, Corporation, Paroxysmal nocturnal hemoglobinuria, Tardive dyskinesia, Parkinson's disease, Publication, DSM-IV codes, Retirement, FDA, PDE7, LDH, Hematology, Mortality, Hematopoietic stem cell transplantation, Bone marrow failure, Abstract, Society, Pharmacology, Pharmaceutical industry

Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.

Key Points: 
  • Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.
  • Total operating expenses for the fourth quarter of 2023 were $39.8 million compared to $48.2 million for the third quarter of 2023.
  • Interest expense during the fourth quarter of 2023 was $7.1 million compared to $7.9 million during the prior quarter.
  • During the fourth quarter of 2023, we earned $3.4 million in interest and other income compared to $4.4 million in the third quarter.

Inspira™ Technologies Reports Full Year 2023 Financial Results

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星期一, 三月 25, 2024
ART, OXY, Research, Annual report, Unitary state, IIA, Intubation, Risk, Patent, Patient, Coma, S&M, Hospital, G&A, Coagulation, Insurance, D&O, Carbon, Human, Hemolysis, Marketing, FDA, Total, Food, Pharmaceutical industry

RA'ANANA, Israel, March 25, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, today announced its financial results for the year ended December 31, 2023.

Key Points: 
  • Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, today announced its financial results for the year ended December 31, 2023.
  • With our ground-breaking technologies and products, we are not just looking at the horizon but actively shaping it, leveraging our proprietary technologies to make a meaningful impact."
  • Total operating expenses decreased to US$12,133,000 in of the year ended December 31, 2023, from US$14,893,000 in the same period of 2022.
  • As of December 31, 2023, financial liabilities at fair value totaled US$1,470,000 compared to US$26,000.

Extracorporeal Membrane Oxygenation Machine Market Projected to Reach $1,085.63 million by 2030 - Exclusive Report by 360iResearch

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星期三, 三月 13, 2024
Temperature, Component, Growth, LivaNova, Extracorporeal membrane oxygenation, Getinge Group, Intelligence, Fresenius Medical Care, Incidence, COVID-19, Patient, Pulmonary hypertension, Research, Cannula, Meconium aspiration syndrome, Carbon, ECMO, Heart, Arteriovenous, Periodic breathing, Workforce, Blood, Hemolysis, Medtronic, Nursing care plan, PPHN, Table, Ageing, Medical device

The extracorporeal membrane oxygenation (ECMO) machine, a crucial medical device, offers extended cardiac and respiratory support to patients with insufficient gas exchange capabilities, marking a significant advancement in critical care.

Key Points: 
  • The extracorporeal membrane oxygenation (ECMO) machine, a crucial medical device, offers extended cardiac and respiratory support to patients with insufficient gas exchange capabilities, marking a significant advancement in critical care.
  • Furthermore, market prospects include integrating ECMO with other extracorporeal treatments and concentrated research efforts to expand usage indications.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Extracorporeal Membrane Oxygenation Machine Market.
  • "Dive into the Extracorporeal Membrane Oxygenation Machine Market Landscape: Explore 196 Pages of Insights, 474 Tables, and 26 Figures"

Extracorporeal Membrane Oxygenation Machine Market Projected to Reach $1,085.63 million by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
星期三, 三月 13, 2024
Temperature, Component, Growth, LivaNova, Extracorporeal membrane oxygenation, Getinge Group, Intelligence, Fresenius Medical Care, Incidence, COVID-19, Patient, Pulmonary hypertension, Research, Cannula, Meconium aspiration syndrome, Carbon, ECMO, Heart, Arteriovenous, Periodic breathing, Workforce, Blood, Hemolysis, Medtronic, Nursing care plan, PPHN, Table, Ageing, Medical device

The extracorporeal membrane oxygenation (ECMO) machine, a crucial medical device, offers extended cardiac and respiratory support to patients with insufficient gas exchange capabilities, marking a significant advancement in critical care.

Key Points: 
  • The extracorporeal membrane oxygenation (ECMO) machine, a crucial medical device, offers extended cardiac and respiratory support to patients with insufficient gas exchange capabilities, marking a significant advancement in critical care.
  • Furthermore, market prospects include integrating ECMO with other extracorporeal treatments and concentrated research efforts to expand usage indications.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Extracorporeal Membrane Oxygenation Machine Market.
  • "Dive into the Extracorporeal Membrane Oxygenation Machine Market Landscape: Explore 196 Pages of Insights, 474 Tables, and 26 Figures"

Inspira™ Releases New Data Demonstrating Superiority of its Core Technology, Across Key Endpoints of HMSS Indicator

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星期二, 三月 12, 2024
ART, OXY, Annual report, Unitary state, Pressure, Risk, Patent, Inflammation, Patient, Coma, Carbon, Human, Bleeding, Hemolysis, Blood, Intubation, Medical device

The performance of the VORTX™, tested according to a regulatory guideline, was found to meet 100% of blood oxygenation requirements at various blood flow rates.

Key Points: 
  • The performance of the VORTX™, tested according to a regulatory guideline, was found to meet 100% of blood oxygenation requirements at various blood flow rates.
  • A significant leap forward in the development of safer, more effective medical devices designed to minimize patient risk and improve clinical outcomes.
  • The advanced experiments demonstrated the primary performance of the VORTX™ by collecting data on oxygenation, carbon dioxide removal, and pressures across the device during blood use.
  • This stands in stark contrast to membrane-based devices, which typically experience significant pressure drops, leading to potential damage to the patient's blood.

Inspira™ introduces high-end platform for bio-mimicking blood parameters for development and testing of core technologies

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星期四, 二月 22, 2024
Coma, Risk, Blood, Unitary state, Annual report, Carbon, ART, Element, Patient, OXY, Tissue, Intubation, Research, Human, Hemolysis, Medical device

This platform has played, and will continue to play, a vital role in advancing the development of our HYLA Blood Sensor and VORTX Orbiting blood oxygenation delivery system, which are the core technologies of the Inspira ART500.

Key Points: 
  • This platform has played, and will continue to play, a vital role in advancing the development of our HYLA Blood Sensor and VORTX Orbiting blood oxygenation delivery system, which are the core technologies of the Inspira ART500.
  • Using unique methods and equipment, our team of scientists has the ability to simulate human blood conditions based on a predefined medical profile.
  • This platform allows Inspira Technologies to control the blood parameters over a wide range, allowing it to test the efficacy and accuracy of its technologies in key scenarios, such as simulating the blood parameters of patients who may suffer from acute medical conditions.
  • The Chief Technology Officer of Inspira Technologies, Dr. Daniella Yeheskely-Hayon, stated: "Inspira Technologies focuses on developing advanced blood monitoring and oxygen delivery technologies through its high-end testing platforms which allows it perform wider range-controlled testing while minimizing the need to perform in vivo animal testing."

Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment

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星期一, 二月 12, 2024
LDH, Infection, FDA, Food, Hemoglobinuria, Paroxysmal nocturnal hemoglobinuria, Alternative complement pathway, ODD, Safety, Atypical hemolytic uremic syndrome, ANCA, Death, Patient, Hyperlipidemia, AP, Diagnosis, AAV, PNH, Chelsea Handler, Hemolysis, Pharmaceutical industry

FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH.

Key Points: 
  • FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH.
  • The FDA has approved phase 1b/Phase II clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 Glomerulopathy (C3G), Atypical Hemolytic Uremic Syndrome (aHUS), and most recently, ANCA vasculitis (AAV).
  • CLEVELAND, Feb. 12, 2024 (GLOBE NEWSWIRE) --  NovelMed today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • FDA's recognition of Ruxoprubart as an orphan drug for PNH underscores its potential to fulfill a crucial need for individuals grappling with this disease condition.

Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

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星期二, 一月 2, 2024
Patient, Medical Subject Headings, Marketing, Protein, Risk, Immune system, Infection, ATC, Neisseria meningitidis, Paroxysmal nocturnal hemoglobinuria, Bleeding, PNH, Disease, Headache, Pharmacist, LDH, Language, Vaccination, Medicine, Blood, Laboratory, European Medicines Agency, C5, Select, Cell, Safety, Hemolysis, Bacteria, Anatomy, Paroxysmal attack, Anemia, Hematology, IIA, Skin, Medical device

Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Epysqli, Date of authorisation: 26/05/2023, Revision: 1, Status: Authorised