Factor X

Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, January 3, 2024
Phase, Coagulation, Food, Emergency medicine, Risk, Vitamin K, PCC, Hemostasis, FDA, Warfarin, Bleeding, INR, Massachusetts General Hospital, Hospital, Thrombophilia, MD, Doctor of Philosophy, Factor X, Factor IX, Clinical trial, Prothrombin time, Trial of the century, Coagulation factor VII, Octapharma, VKA, Patient, Safety, Harvard Medical School, Thrombin, Pharmaceutical industry

PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

Key Points: 
  • The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
  • Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers.
  • "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future.
  • Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk.

Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, July 26, 2023
Embolism, Factor IX, Bleeding, Health, Prothrombin time, Factor X, Stroke, Food and Drug Administration, Clinical trial, Thrombophilia, VKA, Octapharma, PCC, INR, Coagulation, Warfarin, Hemostasis, Patient, Protein C, Risk, Physician, Coagulation factor VII, Vitamin K, Trial of the century, Phase, FDA, Thrombin, Food, Safety, Pharmaceutical industry, Medical imaging

Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.

Key Points: 
  • Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.
  • The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the U.S. and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103).
  • We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation."
  • Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro ®.

4D Bioprinting Global Market Report 2023: Scientific Literature on the Subject Increases by 130% in Five Years Signifying Potential - ResearchAndMarkets.com

Retrieved on: 
Monday, January 16, 2023
Hardware, Chemicals, Plastics, Manufacturing, Other Health, Technology, University, Pharmaceutical, Education, Medical Devices, Other Technology, Biotechnology, Science, Research, Health, Medical Supplies, Engineering, Printing, Attention, Publication, Tissue, Benchmarking, Porter's five forces analysis, 3D bioprinting, Pressure, Type, 3D, Factor X, Water, Elective surgery, Material, Growth, Drug discovery, Tissue engineering, Electronics, Software, Wound healing, Stereolithography, Enzyme, Light, Nature, Electricity, Severe plastic deformation, Regenerative medicine, 3D printing

4D bioprinting makes this possible; 4D bioprinting refers to the incorporation of a fourth dimension that enables these structures to change their shape with time.

Key Points: 
  • 4D bioprinting makes this possible; 4D bioprinting refers to the incorporation of a fourth dimension that enables these structures to change their shape with time.
  • It is worth highlighting that 4D bioprinting is garnering a lot of attention from academicians and industry players.
  • In fact, the volume of affiliated scientific literature has increased at a rate of ~130% since last five years, demonstrating the growing popularity of 4D bioprinting.
  • It offers a high-level view on the likely evolution of the 4D bioprinting market in the short to mid-term, and long term.

LinusBio Raises $16 Million to Scale Growth and Deliver Tangible Outcomes

Retrieved on: 
Thursday, January 12, 2023
Mental Health, Managed Care, Medical Devices, General Health, Hospitals, Neurology, Science, Genetics, Clinical Trials, FDA, Biotechnology, Health, Health Technology, Other Science, Research, Biometrics, Oncology, Partner (business rank), Psychosis, Farmer, Union, Entrepreneurship, Francisco Partners, Cancer, Physiology, Factor X, Autism, White House, Degenerative disease, ALS, General partnership, CE marking, Amyotrophic lateral sclerosis, Hair, PECASE, Environment, Biomarker, FDA, Organization, Diagnosis, Inflammatory bowel disease, Genomics, Investment, DRS, Science, White, Gastroenterology, Kidney, Farmers Business Network, Schizophrenia, Medical imaging, Medicine, Salesforce

It is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner.

Key Points: 
  • It is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner.
  • “Our mission is simple: to deliver better outcomes for people and families affected by complex health conditions,” said Manish Arora, PhD., Co-Founder and CEO of LinusBio.
  • “LinusBio has the opportunity to fundamentally transform the healthcare industry.”
    Arora, the CEO of LinusBio, is an environmental epidemiologist and exposure biologist.
  • The funding will be used to grow the LinusBio team, deliver more positive outcomes across more health conditions, and develop a world-class platform that will serve as a central hub for diagnostics and treatment.

Investment in Site Enablement to Accelerate Research Grows 300% - Florence Healthcare Releases State of Clinical Trial Technology Report

Retrieved on: 
Wednesday, January 11, 2023
Software, Research, Other Health, Pharmaceutical, Data Management, Technology, Medical Devices, Hospitals, Clinical Trials, Science, Biotechnology, Practice Management, Health, Clinical trial, Cros, Factor X, Scottish Centre for Enabling Technologies, EPRO, ESourcing Capability Model, Acceleration, Degenerative disease, Patient, Software, Research, Cancer, Enablement, DCT, Pharmaceutical industry

Florence Healthcare™, a clinical research technology company, has released its annual State of Clinical Trial Technology Report .

Key Points: 
  • Florence Healthcare™, a clinical research technology company, has released its annual State of Clinical Trial Technology Report .
  • Over four hundred clinical research sites, sponsors, and Contract Research Organizations (CROs) responded to the survey about how they plan to invest in software for their 2023 studies.
  • “The survey responses make it clear that 2023 is the year of Site Enablement,” said Catherine Gregor, Chief Clinical Trial Officer for Florence Healthcare.
  • “It’s clear that trial sites are gaining power over research technology decisions,” said Ryan Jones, CEO of Florence Healthcare.

Foghorn Therapeutics Highlights Recent Clinical and Research Progress and Provides Strategic Objectives for 2023

Retrieved on: 
Monday, January 9, 2023
Synovial sarcoma, MDS, Gene expression, Myelodysplastic syndrome, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lilly, Cancer, Merck, AML, Trial of the century, Safety, Precision medicine, FDA, CBP, BRM, Postcholecystectomy syndrome, Biology, Factor X, Food, ARID1B, Therapy, Mum, Patient, Observation, BRD9, Retinoic acid syndrome, Chromatin, Pharmaceutical industry, Vaccine, Cryptocurrency, Foghorn, Grand Street station (IND Sixth Avenue Line)

Mr. Gottschalk continued, “Foghorn is a leader in targeting chromatin biology, which has unique potential to address underlying dependencies of many genetically defined cancers.

Key Points: 
  • Mr. Gottschalk continued, “Foghorn is a leader in targeting chromatin biology, which has unique potential to address underlying dependencies of many genetically defined cancers.
  • Over the next four years, we anticipate the filing of at least six new INDs, reflecting the productivity of our precision medicine platform.
  • Initial Phase 1 clinical data is expected in the first half of 2023.
  • The Company anticipates providing clarity on the development path for FHD-286 in AML/MDS in the first half of 2023.

Kronos Bio Announces Discovery Collaboration with Genentech to Advance Novel Therapies Against Transcriptional Targets in Oncology

Retrieved on: 
Monday, January 9, 2023
Hoffmann-La Roche, SMM, Kronos, Partnership, Factor X, Biology, Patient, Genentech, KRON, Research, Cancer, SAN, Fine chemical, Pharmaceutical industry

SAN MATEO, Calif. and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, announced today that it has entered into a discovery collaboration in the field of oncology with Genentech, a member of the Roche Group, focused on discovering and developing small-molecule drugs that modulate transcription factor targets selected by Genentech.

Key Points: 
  • The partnership will allow Genentech to leverage Kronos Bio’s expertise to identify protein-protein interactions, genetic dependencies and gene expression signatures to better understand and target the oncogenic activity of transcription factors in cancer types of interest.
  • Under the collaboration, researchers at the two companies will collaborate using Kronos Bio’s proprietary drug discovery platform, including the small molecule microarray (SMM) for hit finding, to build upon research conducted to date by Genentech.
  • “We are pleased to be able to leverage our unique platform to collaborate with Genentech to further Kronos Bio’s understanding of transcription-driven oncogenesis and ability to identify novel targets involved.”
    Kronos Bio will lead discovery and research activities to a defined preclinical point when Genentech will have the exclusive right to pursue further preclinical and clinical development and commercialization.
  • “We are excited about the possibilities that this collaboration with Kronos Bio brings to further our understanding of complex scientific networks with the goal of bringing highly effective medicines to patients,” said James Sabry, Global Head of Roche Pharma Partnering.

Genprex Signs Exclusive License to Additional Diabetes Technology with the University of Pittsburgh

Retrieved on: 
Thursday, January 5, 2023
Cancer, Pancreas, University, Mouse, Insulin, Glucagon, MD, Type 1, AAV, Diabetes, Factor X, PDX1, Autoimmunity, Division, Wilfrid Sellars, Disease, Patient, Pediatrics, Type 2, Macrophage, Type 2 diabetes, Pitt, University of Pittsburgh School of Medicine, MAF (gene), Patent, Immune system, Human, Gene, Pharmaceutical industry

AUSTIN, Texas, Jan. 5, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced it has entered into an exclusive license agreement (the Agreement) with the University of Pittsburgh (Pitt), granting Genprex a worldwide, exclusive license to a patent application and related technology and a worldwide, non-exclusive license to use certain related know-how, all related to gene therapy for Type 2 diabetes using the genes of the Pdx1 and MafA transcription factors. The preclinical technology, GPX-003, is believed to work by rejuvenating diminished beta cells to increase insulin expression by introducing transcription factors controlled by an insulin promoter.

Key Points: 
  • "This marks the Company's third technology license this year supporting our diabetes program, demonstrating the continued strengthening of our intellectual property portfolio, our diabetes program, and our position as a lead innovator in emerging diabetes gene therapies," said Rodney Varner, President and Chief Executive Officer of Genprex.
  • "We are thrilled to have secured multiple cutting edge technologies from Pitt that expand our diabetes gene therapy program and specifically target Type 1 and Type 2 diabetes."
  • Genprex recently announced a license agreement with the University of Pittsburgh for a preclinical technology that transforms macrophages enabling them to reduce autoimmune activity in Type 1 diabetes, a technology that could be complementary to the Company's GPX-002 diabetes technology.
  • More than 537 million people around the world have diabetes, and in the U.S. alone, there are 37.3 million people with diabetes.

Inventiva draws down €25 million tranche under Finance Contract with the European Investment Bank

Retrieved on: 
Monday, December 12, 2022
Finance, Mucopolysaccharidosis, IVA, Factor X, Pharmacology, Partnership, Food, Sale, Chronic liver disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MPS, NASH, Pharmacokinetics, European Investment Bank, ISIN, Fruit, Exercise, EIB, Commercial code, Fatty liver disease, Research, Computational chemistry, Sino Biopharmaceutical Limited, Biology, ATM, Patient, MPS VI, Pharmaceutical industry, Security (finance), Euronext Paris

Jean Volatier, Chief Financial Officer of Inventiva, stated: “We are pleased to see that our long-term partnership with the EIB is bearing fruit.

Key Points: 
  • Jean Volatier, Chief Financial Officer of Inventiva, stated: “We are pleased to see that our long-term partnership with the EIB is bearing fruit.
  • Any drawings under the terms of the Finance Contract that have not been disbursed within 36 months from the signing of the Finance Contract, (i.e., before May 16, 2025), cannot be completed at a later date.
  • On November 4, 2022, the Company received an upfront payment of $12 million under its collaboration agreement with Sino Biopharm.
  • on December 8, 2026), (ii) a change of control event, (iii) an event of default under the Finance Contract, or (iv) a repayment demand by EIB under the Finance Contract.

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

Retrieved on: 
Sunday, December 11, 2022
Research, Parenting, Baby, Maternity, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Other Science, Intracranial hemorrhage, Phase, Arm, Leg, Lung, Ixa, Factor, Female, Thrombotic microangiopathy, Haemophilia, Inherited disorders of trafficking, Life, Protein, Skin, APCC, Society, TMA, ABR, Patient, Blood, RO, HAVEN, Parent, Bleeding, AE, Woman, World government, Quality of life, ROG, Caregiver, Clinical trial, VIII, Safety, Brain, Hoffmann-La Roche, Pharmacokinetics, World Federation of Hemophilia, Trauma, AES, ASH, Factor X, Risk, Birth control, Pharmaceutical industry, Emicizumab, Genentech

The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Key Points: 
  • The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.
  • Hemlibra provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • HAVEN 7 is a Phase III, multi-center, open-label study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of Hemlibra in infants with severe hemophilia A without factor VIII inhibitors.
  • Genentech also presented data from the European Haemophilia Safety Surveillance (EUHASS) database and the prospective observational ATHN 7 study at ASH 2022.