Thrombocytopenia

Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Date of authorisation: 17/12/2008, Revision: 27, Status: Authorised

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Martedì, Gennaio 2, 2024
Liver, Marketing, INN, Risk, Leukopenia, Woman, Nausea, DNA, Cancer, Death, Anatomy, Pancreatic serous cystadenoma, IIA, CHMP, Skin, Bone marrow, ATC, IPSS, Myeloid tissue, European, Ageing, MDS, Abdomen, Kidney, Neutrophil, Blood, Syndrome, Thigh, Patient, RNA, Medical Subject Headings, European Commission, WHO, B cell, International, Neutropenia, Language, CMML, Myelodysplastic syndrome, Thrombocytopenia, Monocyte, Select, HSCT, Medicine, Vomiting, Cytidine, Survival, Classification, Stomach, Myelocyte, Growth, Committee, AML, Acute leukemia, Medical device

Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Date of authorisation: 17/12/2008, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Date of authorisation: 17/12/2008, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

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Martedì, Gennaio 2, 2024
Marketing, INN, Risk, Constipation, Needle, Body surface area, Nausea, DNA, Cancer, T-ALL, Anatomy, Paresthesia, Cough, IIA, Hypoesthesia, Diarrhea, Fever, Fatigue, Infection, Bone marrow, ATC, Pain, Disease, Ageing, Somnolence, Periodic breathing, Cerebral edema, Edema, Enzyme, Safety, Anemia, Tumor lysis syndrome, Patient, Medical Subject Headings, Febrile neutropenia, Agency, Guanine, International, Paralysis, LBL, Neutropenia, Blood, Language, Myalgia, Dizziness, Thrombocytopenia, Nervous system, Thymus, Select, Vomiting, Peripheral neuropathy, Survival, Lymph, Extremities, System, Weakness, Headache, Brain, Swelling, European Medicines Agency, Convulsion, Growth, Cell, Lymphatic system, Medical device

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

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Martedì, Gennaio 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

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Martedì, Gennaio 2, 2024
Medical Subject Headings, Marketing, INN, B-cell lymphoma, Infection, ATC, Pharyngitis, Pneumonia, Pain, CD20, Hypertension, Capsule, International, Bleeding, European, Platelet, Disease, Nose, Neutropenia, Language, Mouth, Cancer, Chronic lymphocytic leukemia, Waldenström macroglobulinemia, Thrombocytopenia, Lymphocytosis, Death, Rituximab, CLL, Neutrophil, DSM-IV codes, European Medicines Agency, BTK, Growth, Select, Patient, Bruise, Time, Anatomy, Bone marrow, IIA, Macroglobulinemia, Rash, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 29, Status: Authorised

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Martedì, Gennaio 2, 2024
Janus, Liver, Marketing, PV, INN, Hypertension, Graft-versus-host disease, Polycythemia, Hydroxycarbamide, Infection, Transplant, Splenomegaly, Bruise, Polycythemia vera, Bacteria, Anatomy, IIA, Spleen, Fever, Hypercholesterolemia, Primary myelofibrosis, ATC, Bleeding, Disease, Ageing, JAK, Neutrophil, Blood, System, Disorder, Weight gain, Enzyme, Safety, Anemia, Sepsis, Medical Subject Headings, Agency, B cell, International, Bone pain, Neutropenia, Language, Mouth, Dizziness, Thrombocytopenia, Pancreatic serous cystadenoma, Hypertriglyceridemia, Tablet, Select, Patient, Medicine, Phlebotomy, Hormone, Woman, Weight loss, Headache, Cytomegalovirus, European Medicines Agency, Growth, Janus kinase, Urinary tract infection, Medical device

Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 29, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 29, Status: Authorised

EQS-News: MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study 

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Sabato, Dicembre 30, 2023
Spleen, Patient, EST, Food, TNF, Survival, Constipation, Bone marrow, BET, Prognosis, Diarrhea, Plasma, Anemia, Fatigue, Headache, Disease, Nausea, GMT, Ruxolitinib, Thrombocytopenia, Weakness, Dizziness, ASH, JAK, MorphoSys, COVID-19, Periodic breathing, European Medicines Agency, IL-6, PST, Development, Fibrosis, Cough, Dysgeusia, FACP

Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.

Key Points: 
  • Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
  • Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
  • Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
  • “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.

Keros Therapeutics Presents Clinical Data from its KER-050 Program at the 65th American Society of Hematology Annual Meeting and Exposition

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Lunedì, Dicembre 11, 2023
Patient, Quality of life, Erythropoietin, Protein, Exposition, Fever, Reticulocyte, Homeostasis, Bone marrow, MF, IWG, Haematopoiesis, Research, Erythropoiesis, Diarrhea, Anemia, KROS, Fatigue, Nausea, Headache, RBC, Iron overload, Society, MDS, Therapy, Weakness, Ruxolitinib, Thrombocytopenia, ASH, TI, Week, Periodic breathing, MBBS, Biomarker, Safety, Acute myeloid leukemia, HTB, Cytopenia, Disorder, Pharmaceutical industry

“Additionally, we are encouraged by the preliminary data from the lowest three dose cohorts from our ongoing Phase 2 clinical trial in MF.

Key Points: 
  • “Additionally, we are encouraged by the preliminary data from the lowest three dose cohorts from our ongoing Phase 2 clinical trial in MF.
  • Data for hematological response and markers of hematopoiesis were presented from exploratory analyses of these mITT24 patients.
  • All data presented from this trial is as of the data cut-off date.
  • 13 of those 18 patients (72.2%) achieved TI for at least 24 weeks over the first 48 weeks of treatment.

Allogene Therapeutics Presents Comprehensive Safety Data of Proprietary Lymphodepletion Agent ALLO-647 at the 65th Annual Meeting of the American Society of Hematology

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Sabato, Dicembre 9, 2023
Research and development, Incidence, Anemia, Kite Pharma, SAN, Society, Therapy, Follicular lymphoma, Cancer, Thrombocytopenia, ASH, B-cell lymphoma, Patient, Development, Cytopenia, FC, Vaccine

The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.

Key Points: 
  • The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.
  • Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs.
  • Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients.
  • Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy.2-4

CorMedix Inc. Announces Partnership With The Leapfrog Group

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Lunedì, Dicembre 4, 2023
Patient, Policy, Food, HIT, Risk, CVC, FDA, Kidney failure, Male, Patient safety, Health, Diabetes, Nausea, Incidence, Thrombocytopenia, Hypersensitivity, Dizziness, Death, Breastfeeding, Infection, Patient safety organization, Infant, GAIN, CLS, Safety, Organization, QIDP, Female, Heparin, Vomiting, Pharmaceutical industry

BERKELEY HEIGHTS, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced an agreement with The Leapfrog Group, an independent national watchdog organization of employers and other purchasers focused on health care safety, whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee.

Key Points: 
  • As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization’s long-term strategic vision.
  • “An alliance between The Leapfrog Group and CorMedix brings together two organizations both focused on a common goal: improving patient safety and quality of care across the U.S. healthcare system,” said Joseph Todisco, Chief Executive Officer, CorMedix.
  • “CorMedix is dedicated to developing solutions that reduce the risk of healthcare associated infections, in particular catheter-related bloodstream infections (CRBSIs).
  • Every American deserves the highest quality health care, and together with CorMedix we can achieve our shared vision for excellence,” said Leah Binder, Leapfrog president and CEO.

SELLAS Life Sciences Reaches Target Enrollment ex-China in Phase 3 REGAL Trial of Galinpepimut-S in Acute Myeloid Leukemia

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Mercoledì, Novembre 29, 2023
Doctor of Science, Food, Tumor microenvironment, GPS, FDA, File, CMC, MD, Orphan, United, Thrombocytopenia, SLS, IDMC, Fast track (FDA), Patient, Acute myeloid leukemia, AML, Food and Drug Administration, BLA, Pharmaceutical industry

“Reaching target enrollment ex-mainland China in this important study represents a significant milestone for SELLAS, the GPS development program, and the AML patient community,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

Key Points: 
  • “Reaching target enrollment ex-mainland China in this important study represents a significant milestone for SELLAS, the GPS development program, and the AML patient community,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • REGAL is the most comprehensive study conducted by a biotech company to date in this orphan disease setting.
  • GPS has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union for AML.
  • For more information on the REGAL Phase 3 trial of GPS for the treatment of AML, please visit ClinicalTrials.gov and reference Identifier NCT04229979.