Platelet

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

Retrieved on: 
Lundi, avril 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.

SIAM Announces Class of 2024 Fellows

Retrieved on: 
Jeudi, mars 28, 2024
CNRS, Editorial, Mathematics, Sorbonne University, Climate change, Algorithm, Masaryk University, Utrecht University, Data science, State university system, Cornell University, Systems theory, University of Utah, City University, University of Massachusetts, Research, University of British Columbia, Platelet, University, Software, IBM, University of Cambridge, University of Exeter, Statistics, Industrial, Rutgers University, University of Zurich, University of Waterloo, Stanford University, Virginia Tech, Probability, Lehigh University, Engineering, Lawrence Berkeley National Laboratory, Information technology

Philadelphia, PA, March 28, 2024 (GLOBE NEWSWIRE) -- Society for Industrial and Applied Mathematics (SIAM) is pleased to announce the 2024 Class of SIAM Fellows.

Key Points: 
  • Philadelphia, PA, March 28, 2024 (GLOBE NEWSWIRE) -- Society for Industrial and Applied Mathematics (SIAM) is pleased to announce the 2024 Class of SIAM Fellows.
  • Through their various contributions, SIAM Fellows form a crucial group of individuals helping to advance the fields of applied mathematics, computational science, and data science.
  • Hans De Sterck, University of Waterloo, is being recognized for contributions to scientific computing methods including multilevel and nonlinear solvers, and for exemplary scientific leadership and service to SIAM.
  • Fred S. Roberts, Rutgers University, is being recognized for distinguished research in discrete mathematics, leadership of major research centers, and service to SIAM.

Cerus Corporation Announces Positive Topline Results for the Phase 3 Clinical Trial of the INTERCEPT Blood System for Red Blood Cells in Cardiovascular Surgery Patients

Retrieved on: 
Mardi, mars 19, 2024
Medical Supplies, Biotechnology, Practice Management, Other Health, Health, General Health, Health Technology, Medical Devices, Hospitals, Surgery, Clinical Trials, Red blood cell, STARS, Platelet, SPARC, Incidence, AKI, Patient, Corporation, Mitt, News, CERS, RBC, Acute kidney injury, Clinical trial, Antibody, Transfusion medicine, PMA, Safety, DSMB, Data, Food, FDA, Physician, Cerus Corporation, Pharmaceutical industry

Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.
  • There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs.
  • This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs.
  • “We are extremely pleased by the positive topline results of the ReCePI clinical trial,” stated Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer and principal investigator for the ReCePI clinical trial.

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

Retrieved on: 
Mercredi, mars 13, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Fast track (FDA), Psoriasis, Cell, Disease, Risk, Patient, Megakaryocyte, Immunoglobulin G, ITP, B cell, Quality of life, Platelet, Autoantibody, Gastrointestinal tract, CD38, Bleeding, Safety, Dravet syndrome, Blood, Lennox–Gastaut syndrome, Fatigue, Fiscal, Food, Autoimmune disease, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Retrieved on: 
Jeudi, mars 21, 2024
Research, HDAC, Neurological disorder, Walking, Abdominal pain, Dietary supplement, Risk, Inflammation, Patient, QT interval, Public, Animal, Duchenne muscular dystrophy, Diarrhea, Food, Human services, Platelet, Facial muscles, Life expectancy, Heated tobacco product, Fever, Atrophy, Safety, Division, NSAA, Muscle weakness, Cosmetics, Vaccine, Multimedia, FDA, DMD, Muscular dystrophy, Triglyceride, Pharmaceutical industry

SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.

Key Points: 
  • SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older.
  • Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.
  • "This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation."
  • DMD is the most common childhood form of muscular dystrophy and typically affects males.

Zai Lab to Present Final Overall Survival (OS) Data from Phase 3 NORA Study of ZEJULA (niraparib) in Platinum-Sensitive Recurrent Ovarian Cancer (PSROC)

Retrieved on: 
Mercredi, mars 6, 2024
Biotechnology, Other Health, Health, General Health, Women, Pharmaceutical, Oncology, Research, Consumer, Science, Clinical Trials, Progression-free survival, Fudan University, Shanghai Cancer Center, ISD, PARP, ESGO, BRCA, HKEX, Platelet, OS, Gynecologic Oncology (journal), Ovarian cancer, SGO, Patient, Congress, Development, Niraparib, Pharmaceutical industry

“Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.

Key Points: 
  • “Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.
  • “We look forward to sharing the final OS findings from this study at both the 2024 ESGO and SGO conferences.
  • The final OS analysis was conducted after ≥ 50% of OS events occurred in the intent-to-treat population.
  • No new safety signals were identified during the long-term follow up period subsequent to the primary analysis.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Retrieved on: 
Mardi, février 27, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Incidence, Progression-free survival, European Commission, Tislelizumab, Anemia, Quality of life, Food, File, ESCC, BLA, Nausea, Vomiting, BGNE, Platelet, Safety, Stomach, Civil service commission, Death, Patient, Survival, Biologics license application, Appetite, Cancer, Pharmaceutical industry

“In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.

Key Points: 
  • “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.
  • Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
  • The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.
  • A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.

Family Dentistry of Frisco Introduces Advanced Dental Implant Solutions with Innovative PRP Technique and Comprehensive Sedation Options

Retrieved on: 
Mercredi, mars 6, 2024
Regeneration, DDS, Multimedia, Dentures, Nitrous oxide, Platelet, Dental implant, Quality of life, Overalls, Platelet-rich plasma, Dental, Dental care, Safety, PRP, Patient, Anatomy, Dentistry, Implant

FRISCO, Texas, March 5, 2024 /PRNewswire-PRWeb/ -- Family Dentistry of Frisco, under the esteemed leadership of Dr. Paresh B. Patel, DDS, is proud to announce the expansion of its dental services to include state-of-the-art Dental Implants and Implant Supported Dentures, commonly referred to as All-on-4. These advanced treatments are now enhanced by the innovative use of Platelet-Rich Plasma (PRP) technology, setting a new standard in dental care excellence and patient comfort in the Frisco area.

Key Points: 
  • Family Dentistry of Frisco has proudly announced the introduction of its advanced dental implant solutions, featuring the innovative Platelet-Rich Plasma (PRP) technique and a wide range of comprehensive sedation options.
  • At the forefront of dental technology, Family Dentistry of Frisco incorporates PRP in implant procedures to accelerate healing and improve the success rate of dental implants.
  • Understanding the importance of comfort and ease for our patients, Family Dentistry of Frisco offers multiple levels of sedation dentistry to ensure a calm and pain-free experience during dental implant procedures.
  • The introduction of PRP technology and our comprehensive sedation options exemplify our commitment to pioneering dental treatments that prioritize patient well-being and satisfaction."

Human medicines European public assessment report (EPAR): Zejula, niraparib, Date of authorisation: 16/11/2017, Revision: 32, Status: Authorised

Retrieved on: 
Mardi, janvier 9, 2024
Medical Subject Headings, Diarrhea, Marketing, Platinum, INN, Peritoneum, Constipation, Fatigue, Woman, Ovarian cancer, ATC, Insomnia, Hypertension, Capsule, International, Cough, Tubing (recreation), Weakness, Headache, Disease, Nausea, Neutropenia, Language, DNA, Mouth, Cancer, Neoplasm, Thrombocytopenia, Abdomen, Dizziness, Platelet, PARP, Neutrophil, Appetite, European Medicines Agency, Back pain, Uterus, Enzyme, Select, Cell, Patient, Time, Safety, Anatomy, Anemia, Arthralgia, Vomiting, IIA, Periodic breathing

Human medicines European public assessment report (EPAR): Zejula, niraparib, Date of authorisation: 16/11/2017, Revision: 32, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zejula, niraparib, Date of authorisation: 16/11/2017, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Retrieved on: 
Vendredi, janvier 5, 2024
Patient, Medical Subject Headings, Marketing, Febrile neutropenia, Agency, INN, Fever, Immune system, Risk, Infection, Diffusion, Allergy, DLBCL, ATC, Bone marrow, Cytokine release syndrome, CD20, Platelet, International, Headache, Disease, Neutropenia, Blood, Language, Pleural effusion, Cancer, B-cell lymphoma, Thrombocytopenia, Neutrophil, Rituximab, COVID-19, European Medicines Agency, Select, Bacteria, Anatomy, Anemia, IIA, Sepsis, CD3, Rash, Medical device

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised