Coagulopathy

Gyre Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
Hepatitis, KPMG, GNI, Cirrhosis, Patient, Chronic obstructive pulmonary disease, Sale, Coagulopathy, Ernst & Young, Idiopathic pulmonary fibrosis, Fibrosis, Therapy, COPD, Marketing, Partnership, Arthur Andersen, Audit committee, SAN, Safety, CVR, CHB, Fatty liver disease, Prevalence, Pharmacy, Hospital, Research, Acquisition, TGF, Pirfenidone, GAAP, Toxicity, Inflammation, Accounting, Entecavir, Loss, Orthostatic hypertension, IPF, Partner, NASH, Category 1, Pharmaceutical industry

Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.

Key Points: 
  • Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.
  • In October 2023, Gyre (formerly known as Catalyst Biosciences, Inc. (“Catalyst”)) completed the previously announced business combination with GNI Group Ltd. (“GNI”) and related entities.
  • In October 2023, Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC.
  • Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
    Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

BioTek reMEDys Promotes Awareness and Education for Bleeding Disorders Awareness Month

Retrieved on: 
Wednesday, March 20, 2024
Research, Infectious Diseases, Public Policy, Government, Healthcare Reform, Biotechnology, Health, Pharmaceutical, General Health, Science, Diagnosis, Coagulopathy, Haemophilia, Caregiver, Education, Patient, Von Willebrand disease, Pharmacist, Blood, Physician, BioTek

In recognition of March being Bleeding Disorders Awareness Month , BioTek reMEDys , a multi-site national integrated infusion therapy provider focused on providing support to people with rare diseases, is publicly calling for awareness of safe medication use and treatments for patients with bleeding disorders and conditions.

Key Points: 
  • In recognition of March being Bleeding Disorders Awareness Month , BioTek reMEDys , a multi-site national integrated infusion therapy provider focused on providing support to people with rare diseases, is publicly calling for awareness of safe medication use and treatments for patients with bleeding disorders and conditions.
  • “Bleeding Disorders Awareness Month is an opportunity and a reminder to advocate for education as a priority throughout the healthcare continuum as we work towards recognizing the challenging journey patients often have on the way to a correct diagnosis and treatment."
  • Each March, the community calls attention to inheritable blood and bleeding disorders during Bleeding Disorders Awareness Month.
  • To learn more about hemophilia, von Willebrand disease, rare factor disorders and other bleeding disorders, visit hemophilia.org .

Pathway to Cures Announces First Entrepreneur in Residence

Retrieved on: 
Monday, March 11, 2024
Other Philanthropy, Biotechnology, Pharmaceutical, Health, Philanthropy, Fund Raising, Foundation, Other Health, Disease, Coagulopathy, Sickle cell disease, Heredity, Spark Therapeutics, Rush University Medical Center, Entrepreneur in residence, Knowledge, Mortality, Baxalta, EIR, Doctor of Philosophy, MD, MBA, Therapy, Anemia, Blood

Pathway to Cures (P2C) announced today its first Entrepreneur in Residence (EIR), Leonard Valentino, M.D.

Key Points: 
  • Pathway to Cures (P2C) announced today its first Entrepreneur in Residence (EIR), Leonard Valentino, M.D.
  • Dr. Valentino most recently served as President and CEO of the National Bleeding Disorders Foundation (NBDF) and was instrumental in bringing Pathway to Cures into reality.
  • Pathway to Cures is the venture philanthropy fund of the NBDF focused on early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community.
  • “My role as Entrepreneur in Residence for Pathway to Cures will be to provide guidance into the consideration and support of new opportunities for catalyzing transformative therapies and cures.

FDA Grants HemoSonics Expanded Use of its Critical Bleeding Management System with Special 510(k) Clearance

Retrieved on: 
Wednesday, April 3, 2024
Patient, Trauma, Hospital, Acquisition, Coagulopathy, Cartridge, Operating, Hemostasis, American Red Cross, Bleeding, Intensive care medicine, FDA, Liver, Journal of Cardiothoracic Surgery, Food, Medical device

DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics, a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge. HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples. Today's announcement enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics' QStat Cartridge and the QPlus® Cartridge.

Key Points: 
  • HemoSonics' Quantra® Hemostasis Analyzer provides comprehensive blood analysis that details critical bleeding disorders and helps clinicians manage patients back into hemostasis.
  • DURHAM, N.C., April 3, 2024 /PRNewswire/ -- HemoSonics , a medical device company focused on acute bleeding management, today announced it has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of arterial blood samples with its Quantra QStat® Cartridge.
  • HemoSonics' QStat Cartridge used with the Quantra Hemostasis Analyzer first received 510(k) clearance from the U.S. FDA in 2022 for use in venous whole blood samples.
  • "The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system.

The Inner Circle Dean acknowledged Dean M. Kirkel as a Distinguished Life Member

Retrieved on: 
Wednesday, March 13, 2024
Diagnosis, Principal, Internal medicine, Faculty, Coagulopathy, Mentorship, Lymphoma, Hematology, Immunotherapy, Disease, Physician, Alpha Omega Alpha, George Washington University, Education, Private practice, Patient, Research, Fellow, Cancer, University, American College, Society, Mary, mother of Jesus, Breast cancer, Pain management, Multimedia, Medical school, Inner circle, Nursing

MARIETTA, Ga., March 13, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Dean M. Kirkel is acknowledged as a Distinguished Life Member for his contributions to the field of Oncology.

Key Points: 
  • MARIETTA, Ga., March 13, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Dean M. Kirkel is acknowledged as a Distinguished Life Member for his contributions to the field of Oncology.
  • Dr. Kirkle pursued higher education at the University of Witwatersrand, Faculty of Medicine in South Africa where he earned a Medical Doctor degree.
  • He completed an internship and internal medicine residency at St. Mary's Hospital/St Louis University and finished a Fellowship in hematology and oncology at George Washington University.
  • He launched his career in private practice in Boynton Beach, FL, where he provided personalized care to patients battling cancer.

AvevoRx Announces National Director of Pharmacy Operations Named to Triad Business Journal's "40 Leaders Under 40"

Retrieved on: 
Thursday, February 22, 2024
Triad, Licensure, RPH, Coagulopathy, URAC, North Carolina State University, Growth, Doctor of Pharmacy, ACHC, American City Business Journals, University, Patient, Accreditation, USP, Biology, Nursing

GREENSBORO, N.C., Feb. 22, 2024 /PRNewswire-PRWeb/ -- AvevoRx, an independent provider of specialty infusion pharmacy services, is proud to announce its National Director of Pharmacy Operations, Justin R. Dent, PharmD, has been named to the Triad Business Journal's prestigious "40 Leaders Under 40" list. The 2024 list spotlights extraordinary young leaders with significant career achievements who work and are civically engaged in the Triad community of North Carolina.

Key Points: 
  • The 2024 list spotlights extraordinary young leaders with significant career achievements who work and are civically engaged in the Triad community of North Carolina.
  • As its National Director of Pharmacy Operations, Dent ensures the smooth and efficient day-to-day operations of AvevoRx's pharmacy services at scale.
  • Dent's most significant achievements include helping to expand the company's national footprint and experience with pharmacy law and accreditation compliance.
  • "Our founders established a solid base, and we're constantly enhancing our operations to provide specialty pharmacy care to as many patients as possible.

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on: 
Wednesday, January 31, 2024
SAN, Nausea, Clinical trial, Perforation, Birth, Fibroid, Internal bleeding, Liver failure, Infection, Artery, Pelvic pain, DKT International, Jaundice, Anticoagulant, Blood pressure, Ovarian cyst, Woman, Acne, Organization, Partnership, Endometritis, Angioedema, History, Abscess, Contraindication, DKT, Peritonitis, Rash, Coagulopathy, Dyspareunia, Inflammatory cytokine, Adhesion, Vomiting, Bacterial vaginosis, Headache, Bowel obstruction, IUS, Uterus, STI, Breast cancer, Miscarriage, Patient, Fertility, Sepsis, Marketing, Risk, Stroke, Organ, Streptococcus, Hormone-sensitive cancer, Liver tumor, Cyst, Intrauterine device, GAS, Pregnancy, PID, Social marketing, Vaginitis, Migraine, Myocardial infarction, Health, Brain, Birth control

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points: 
  • "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
  • “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
  • As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
  • Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 23, Status: Authorised

Retrieved on: 
Saturday, January 6, 2024
Urinary tract infection, Patient, Medical Subject Headings, Marketing, Agency, Jaw, INN, Interferon beta-1a, Immune system, Fever, Tears, ATC, Disability, Multiple sclerosis, Kidney, Hypertension, International, Blood, RRMS, Attack, Spinal cord, Disease, Headache, Language, Brain, Myocardial infarction, Eye, Heart, Inflammation, Thyroid, Stroke, Head, Angina, European Medicines Agency, Infection, Coagulopathy, Lymphocyte, HIV, Select, Central nervous system, Human, Safety, Anatomy, Checklist, Sclerosis, IIA, Optic nerve, Neck, Rash, CD52, Medical device

Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 23, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 23, Status: Authorised

BioMatrix Specialty Pharmacy Announces Kathee Kramm as CEO

Retrieved on: 
Tuesday, January 2, 2024
Culture, Executive, Coagulopathy, Health, Investment, ACON Investments, Growth, L.L.C, Patient, Nursing

PLANTATION, Fla., Jan. 2, 2024 /PRNewswire/ -- BioMatrix Specialty Pharmacy announced today that the Board of Directors has appointed Kathee Kramm as Chief Executive Officer, succeeding Nick Karalis, founder and former CEO.

Key Points: 
  • PLANTATION, Fla., Jan. 2, 2024 /PRNewswire/ -- BioMatrix Specialty Pharmacy announced today that the Board of Directors has appointed Kathee Kramm as Chief Executive Officer, succeeding Nick Karalis, founder and former CEO.
  • This exciting change is the culmination of a year-long succession plan and an accelerant to BioMatrix's growth in specialty infusion.
  • "Kathee's leadership and proven performance at BioMatrix makes her a natural choice to be the next CEO," said Nick.
  • Prior to BioMatrix, Kathee was co-founder and President of AxelaCare Health Solutions, a leading national provider of specialty home infusion services.