Hemolysis

Horizon to Highlight Novel Insights in Gout Care During the American College of Rheumatology Convergence 2022

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星期一, 九月 19, 2022
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Adult, Rheumatology, Autoimmunity, Courage, RCT, Glucose-6-phosphate dehydrogenase deficiency, Pharmacokinetics, Anaphylaxis, Heart, Kidney, American College, DECT, Lightning, COVID-19, Twitter, Risk, Methemoglobinemia, Immunogenicity, Randomness, Vomiting, LinkedIn, Methotrexate, NSAID, Hypertension, Arthralgia, Hemolysis, History, Instagram, Gout, G6PD, Pain, Nasdaq, EST, Clinical trial, Heart failure, Science, Randomized controlled trial, Boxed warning, Serial, Inflammation, Horizon, Nausea, Fatigue, MIRROR, Colchicine, Pharmaceutical industry, Medical device, Medicine, Facebook, Patient

Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.

Key Points: 
  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion and generally manifests within 2 hours of the infusion.
  • Patients should be premedicated with antihistamines and corticosteroids and closely monitored for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA.

GBT Supports the Sickle Cell Disease Treatment Centers Act of 2022

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星期四, 九月 15, 2022
Center, Oxygen, Acute chest syndrome, Hemolysis, FDA, National Heart, Lung, and Blood Institute, Blood, Polymerization, Legislation, United, Population, Volatile organic compound, Health, Sickle, Stroke, End organ damage, Patient, Sickle cell disease, GBT, Anti-transglutaminase antibodies, Lung, Physician, CEO, The Council, SCD, Data collection, HBS, Centers for Disease Control and Prevention, Life expectancy, Tissue, Caregiver, NASDAQ, European Medicines Agency, Statistics, Research, Capillary, University, SAN, GLOBE, United States $1 Coin Act of 1997, Education, Disease, Council, Anemia, Pharmaceutical industry, Medical device

SOUTH SAN FRANCISCO, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc.(GBT) (NASDAQ: GBT) announced its support for the Sickle Cell DiseaseTreatment Centers Act of 2022, which was introduced today and, if passed in its current form, would authorize for appropriations of $535 million in annual funding to support sickle cell disease (SCD) treatment, research and education.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc.(GBT) (NASDAQ: GBT) announced its support for the Sickle Cell DiseaseTreatment Centers Act of 2022, which was introduced today and, if passed in its current form, would authorize for appropriations of $535 million in annual funding to support sickle cell disease (SCD) treatment, research and education.
  • The key elements of the Sickle Cell DiseaseTreatment Centers Act of 2022 are based on a vision developed by a diverse group of stakeholders representing individuals living with sickle cell disease, caregivers, advocates, community-based organizations, physicians, and payers.
  • The introduction and passing of this act have the potential to dramatically improve the lives of individuals living with sickle cell disease across the United States, said Biree Andemariam, M.D., director of the New England Sickle Cell Institute at the University of Connecticut and the chairperson of The Council for Sickle Cell Disease Health Equity.
  • The establishment and funding of more than 100 treatment centers would ensure far greater access to quality expert care for those living with sickle cell disease around the country, filling a longstanding inequity and largely ignored gap in the current healthcare landscape for the sickle cell disease community.

Hemcheck receives follow up order from its Greek distributor

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星期三, 八月 31, 2022
Hemolysis, Nasdaq, Certification, Medical imaging, Financial adviser, Phosphorus

Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection.

Key Points: 
  • Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection.
  • The concept consists of disposable tests as well as readers that can very quickly, directly upon sampling, identify hemolysed blood samples in vacuum tubes and blood gas syringes.
  • Hemolysis, ruptured red blood cells, is the most common reason globally why blood samples cannot be analyzed accurately and is also a biomarker for acute medical conditions.
  • By doing so, Hemcheck can contribute to increased patient safety, more efficient processes and lower costs.

Alternative Pathway Blocker Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Efficacy Trial in C3 Glomerulopathy (C3G) Patients

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星期一, 八月 15, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Serum, C5-convertase, Inflammation, Properdin, Population, Classical complement pathway, C3b, Disease, Hemolysis, EGFR, USD, Proteinuria, Patient, Therapy, Company, Acquisition, Partnership, AP, Infection, Kidney, MAC, Membranoproliferative glomerulonephritis, Time, BB, CP, Food, MPGN, DDD, Pharmaceutical industry, Vaccine, Eculizumab, C3, C5

CLEVELAND, Aug. 15, 2022 /PRNewswire/ -- NovelMed Therapeutics is a clinical-stage biopharmaceutical company focused on the development of targeted therapies for complement-mediated rare diseases. The Company announced today that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational drug NM8074 to initiate an Efficacy trial in patients with C3G in the First Quarter of 2023. NM8074 has recently completed a Phase I trial in forty (40) healthy volunteers with no safety concerns. 

Key Points: 
  • The Company announced todaythat the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational drug NM8074 to initiate an Efficacy trial in patients with C3G in the First Quarter of 2023.
  • Further, NM8074 also blocks the formation of these proteases by impairing the amplification loop of the AP.
  • Interestingly, NM8074 does not block the classical pathway (CP) which is critical for host defense against infections.
  • Our goal is to develop an alternative pathway specific drug that can treat a multitude of rare diseases and provide patients with low-cost treatment.

Agios Announces Publication of Phase 2 Data in The Lancet Demonstrating Safety and Efficacy of PYRUKYND® (mitapivat) in Non-transfusion-dependent α- and β-Thalassemia

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星期四, 八月 11, 2022
EHA, Hospital, Toronto General Hospital, GLOBE, Transfusion-dependent anemia, Agios, Enzyme, Patient, Thalassemia, NASDAQ, PK, Hemolysis, Head, University, University of Toronto, Health insurance, Pharmaceutical industry, Lancet

CAMBRIDGE, Mass., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that data from the core period of the open-label, Phase 2 study of PYRUKYND® (mitapivat) in adults with non-transfusion-dependent α- or β-thalassemia were published on August 11, 2022, in The Lancet. Data from this study were previously presented at the 2021 European Hematology Association (EHA) Annual Congress. PYRUKYND® is a first-in-class, investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase (PK) enzymes.

Key Points: 
  • Data from this study were previously presented at the 2021 European Hematology Association (EHA) Annual Congress.
  • PYRUKYND is a first-in-class, investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase (PK) enzymes.
  • These data demonstrate the potential clinical benefits of mitapivat for a broad spectrum of thalassemia patients and support its continued investigation in pivotal trials.
  • One patient who had -thalassemia discontinued after Week 4 due to a treatment-emergent adverse event deemed unrelated to the study drug.

Global Hematology Partnering Deal Trends, Players and Financials Report 2022 - ResearchAndMarkets.com

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星期三, 八月 10, 2022
Health, Other Health, Directory, Technology, Vitamin K deficiency, SEC, Finance, DIC, Chapter Four, Agranulocytosis, Chapter Five, Chapter Three, Research, Review, Contract, Disseminated intravascular coagulation, Players, Chapter Six, Iron deficiency, Chapter One, Chapter Two, Hyperlink, Orientation, Video game, Risk management, Sales, Neutropenia, Hemolysis, Polycythemia, Hematology, Thrombocytopenia, Thalassemia, Anemia

The "Global Hematology Partnering 2010-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Hematology Partnering 2010-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering.
  • The Global Hematology Partnering 2010-2022 report provides comprehensive access to available deals and contract documents for over 650 hematology deals signed since 2010.
  • The report takes readers through the comprehensive Hematology disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Hematology deals.
  • Global Hematology Partnering 2010 to 2022 includes:
    In Global Hematology Partnering 2010 to 2022, available deals and contracts are listed by:

Rocket Pharmaceuticals Reports Second Quarter 2022 Financial Results and Highlights Recent Progress

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星期一, 八月 8, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Advaxis, Survival, Good, SEC, Investment, Schering-Plough, Leadership, Dysplasia, Research, Marketing, Patient, Biotechnology, G&A, PKD, Hemolysis, Medication, Overalls, Lists of diseases, Industry, Private Securities Litigation Reform Act, LVV, Merck, Safety, Kaplan–Meier estimator, MMC, BLA, Science, Celgene, Conference, CMC, Heart failure, Bone marrow failure, FA, CDMO, CD18, COVID-19, Infection, Morgan Stanley, Hematopoietic stem cell transplantation, Novartis, Anemia, Chemistry, Pyruvate kinase deficiency, AAV, FDA, Neutrophil, Genetic disorder, CGMP, Achievement, MedImmune, Good manufacturing practice, Quality of life, Company, Liver injury, Risk, NASDAQ, Fanconi anemia, Adult, Pharmaceutical industry, Fine chemical, Health insurance, Tutoring, Q2, Danon disease

Importantly, we continue to maintain a healthy operational cash runway into the first half of 2024, concluded Dr. Shah.

Key Points: 
  • Importantly, we continue to maintain a healthy operational cash runway into the first half of 2024, concluded Dr. Shah.
  • The originally planned Q3 topline readout for FA was achieved earlier than anticipated in Q2 when the trial met its primary endpoint.
  • Pending health authority interactions, Phase 2 trial planning activities are expected to begin in Q4 of 2022.
  • Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes.

The GBT Foundation Awards $250,000 in ACE Grants to Support Sickle Cell Disease Community-Based Organizations

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星期三, 七月 13, 2022
Well, Mindfulness, National Heart, Lung, and Blood Institute, Education, Homeland Security Grant Program, Centers for Disease Control and Prevention, United, Patient, SAN, Oxygen, Sickle cell disease, Lung, Capillary, Tissue, Health equity, Anemia, Transition, Therapy, Organization, GLOBE, Excellent Care for All Act, Volatile organic compound, Disease, Criterion, ACE, Sickle Cell Disease Association of America, Center, Adult, Blood, Health, GBT, Polymerization, FDA, SCD, Hemolysis, Empowerment, Access, European Medicines Agency, Statistics, Government, Sickle, Stroke, HBS, Acute chest syndrome, End organ damage, Head, Caregiver, Andrew Kohut, ACCEL, Pharmaceutical industry, Medicine

Through the ACE Grant Program, The GBT Foundation plans to fund up to $250,000 per year to support initiatives dedicated to advancing health equity and enhancing education, empowerment, and access to care for people living with sickle cell disease (SCD).

Key Points: 
  • Through the ACE Grant Program, The GBT Foundation plans to fund up to $250,000 per year to support initiatives dedicated to advancing health equity and enhancing education, empowerment, and access to care for people living with sickle cell disease (SCD).
  • CBOs can play an important role as local resources for sickle cell disease patients and caregivers as they navigate their healthcare journey.
  • Childrens Sickle Cell Foundation, Inc. (Pittsburgh, Pennsylvania) Living Well with Sickle Cell Family Leadership Program to educate sickle cell family leaders about SCD, care, treatment, and their role in advocacy.
  • Sickle Cell Association of South Louisiana (Lafayette, Louisiana) KNEAUX Sickle Program to support resources for teens transitioning from pediatric to adult SCD healthcare providers.

Hemcheck receives extended order from its French distributor

Retrieved on: 
星期三, 六月 29, 2022
Hemolysis, Certification, Nasdaq, Medical imaging, Financial adviser, Phosphorus

Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection.

Key Points: 
  • Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection.
  • The concept consists of disposable tests as well as readers that can very quickly, directly upon sampling, identify hemolysed blood samples in vacuum tubes and blood gas syringes.
  • Hemolysis, ruptured red blood cells, is the most common reason globally why blood samples cannot be analyzed accurately and is also a biomarker for acute medical conditions.
  • By doing so, Hemcheck can contribute to increased patient safety, more efficient processes and lower costs.

GBT Initiates Phase 2/3 Clinical Trial of GBT601 in Patients with Sickle Cell Disease

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星期三, 六月 29, 2022
Hemolysis, Discovery (observation), Patient, Sickle cell disease, Research, GLOBE, COVID-19, Blood, United States $1 Coin Act of 1997, Oxygen, Polymerization, GBT, FDA, HBS, Securities Act of 1933, Securities Exchange Act of 1934, Tissue, National Heart, Lung, and Blood Institute, PD, Compliance, Pharmacokinetics, SAN, Anemia, Drug Quality and Security Act, SCD, Center, Sickle, Acute chest syndrome, Goal, PK, Private Securities Litigation Reform Act, Capillary, NASDAQ, Lung, Pharmakon—Danish College of Pharmacy Practice, Adult, Stroke, U.S. Securities and Exchange Commission, End organ damage, Disease, United, Registry, Volatile organic compound, Maintenance, Government, Safety, Centers for Disease Control and Prevention, Pharmaceutical industry, HB, Voxelotor

The study ( NCT05431088 ) is a randomized, multicenter Phase 2/3 clinical trial evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of GBT601.

Key Points: 
  • The study ( NCT05431088 ) is a randomized, multicenter Phase 2/3 clinical trial evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of GBT601.
  • Based on compelling preclinical and clinical data, we believe GBT601 has the potential to be a best-in-class therapy for patients with sickle cell disease, said Kim Smith-Whitley, M.D., executive vice president and head of research and development of GBT.
  • The initiation of our Phase 2/3 trial is an important milestone in our efforts to bring GBT601 to patients.
  • GBT601 is being studied in a Phase 1 clinical trial and Phase 2 portion of a Phase 2/3 clinical trial.