Coagulopathy

BioMatrix Infusion Pharmacy Opens New Location in Birmingham, Alabama

Retrieved on: 
Mercoledì, Maggio 8, 2024

PLANTATION, Fla., May 8, 2024 /PRNewswire/ -- BioMatrix Infusion Pharmacy announced today the opening of BioMatrix Infusion Pharmacy AL in Birmingham, Alabama. This infusion-focused pharmacy adds a brick-and-mortar location in a key geographic area, expands the organization's national footprint, and provides access to additional covered lives. This latest location positions BioMatrix as one of the largest privately held specialty pharmacies in the United States.

Key Points: 
  • Alabama Location Expands National Footprint, Payer Contracts, Clinical Expertise
    PLANTATION, Fla., May 8, 2024 /PRNewswire/ -- BioMatrix Infusion Pharmacy announced today the opening of BioMatrix Infusion Pharmacy AL in Birmingham, Alabama.
  • Through this new location, BioMatrix will also provide home infusion nursing support to local residents, providing a more comfortable and convenient infusion experience.
  • An Alabama pharmacy location is part of our strategic plan to expand our infusion services and increase access to covered lives.
  • BioMatrix Infusion Pharmacy AL is located at 300 Riverhills Business Park, Suite 390, Birmingham, Alabama 35242, and will be open Monday through Friday from 8:30am to 5:00pm CST.

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®, the First VWF Concentrate for Prophylaxis in All Types of VWD

Retrieved on: 
Lunedì, Aprile 29, 2024

Patients with severe VWD are recommended to utilize long-term prophylaxis with VWF concentrate.

Key Points: 
  • Patients with severe VWD are recommended to utilize long-term prophylaxis with VWF concentrate.
  • The FDA Orphan Drug Designation program provides orphan status to biologics and drugs for rare diseases.
  • "The FDA orphan exclusivity is exciting news for Octapharma and patients who have endured excessive bleeding episodes," said Octapharma USA President Flemming Nielsen.
  • The Factor My Way patient support program is designed by Octapharma USA for those living with VWD and hemophilia A.

National Organization for Rare Disorders (NORD) Announces 2024 Rare Impact Award Honorees, Emmy Award-Winning Journalist, Peter Alexander to Host

Retrieved on: 
Lunedì, Aprile 22, 2024

"Through science and advocacy, they are transforming the lives of those impacted by rare diseases, paving the way for new possibilities in treatment and care."

Key Points: 
  • "Through science and advocacy, they are transforming the lives of those impacted by rare diseases, paving the way for new possibilities in treatment and care."
  • "Having witnessed my sister's journey, I know the challenges rare disease families face are not just physical but also emotional, mental, and financial.
  • In addition to the individual award recipients, the Rare Impact Awards are also honoring companies that have developed treatments changing the lives of those with rare diseases.
  • Regeneron Pharmaceuticals for Veopoz™: The first and only treatment indicated specifically for CHAPLE disease, a rare hereditary immune disease.

World Hemophilia Day 2024"Equitable access for all: recognizing all bleeding disorders"

Retrieved on: 
Mercoledì, Aprile 17, 2024

MONTREAL, April 17, 2024 /PRNewswire/ -- On April 17, 2024, the global bleeding disorders community will come together to celebrate World Hemophilia Day.

Key Points: 
  • MONTREAL, April 17, 2024 /PRNewswire/ -- On April 17, 2024, the global bleeding disorders community will come together to celebrate World Hemophilia Day.
  • The theme of the event this year is "Equitable access for all: recognizing all bleeding disorders".
  • The World Federation of Hemophilia (WFH) vision of Treatment for All is for a world where all people with inherited bleeding disorders have access to care, regardless of their type of bleeding disorder, gender, age, or where they live.
  • This April, let's celebrate our community and continue working towards a world where everyone—with hemophilia A or B, von Willebrand disease (VWD) or any other bleeding disorder—has access to diagnosis, treatment, and comprehensive care.

World Hemophilia Day 2024"Equitable access for all: recognizing all bleeding disorders"

Retrieved on: 
Mercoledì, Aprile 17, 2024

MONTREAL, April 17, 2024 /PRNewswire/ - On April 17, 2024, the global bleeding disorders community will come together to celebrate World Hemophilia Day.

Key Points: 
  • MONTREAL, April 17, 2024 /PRNewswire/ - On April 17, 2024, the global bleeding disorders community will come together to celebrate World Hemophilia Day.
  • The theme of the event this year is "Equitable access for all: recognizing all bleeding disorders".
  • The World Federation of Hemophilia (WFH) vision of Treatment for All is for a world where all people with inherited bleeding disorders have access to care, regardless of their type of bleeding disorder, gender, age, or where they live.
  • This April, let's celebrate our community and continue working towards a world where everyone—with hemophilia A or B, von Willebrand disease (VWD) or any other bleeding disorder—has access to diagnosis, treatment, and comprehensive care.

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

Retrieved on: 
Martedì, Marzo 26, 2024

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: 
Sabato, Aprile 6, 2024

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: 
Mercoledì, Marzo 20, 2024

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: 
Lunedì, Marzo 11, 2024

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: 
Mercoledì, Aprile 3, 2024

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.