Prothrombin time

Vivacelle Bio and University of Missouri-Kansas City School of Medicine Announce Groundbreaking Results from Phase 2a Clinical Trial of VBI-S for Refractory Hypotension in Severe Septic Shock Patients

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星期四, 二月 29, 2024
Real-time, Prothrombin time, Sepsis, MD, Inflammation, FDA, Infection, University, Nitric oxide, Hope, Pelvic floor dysfunction, Safety, Lancet, Disease, Patient, Optimism, Septic shock, Clinical trial, Survival, Mortality, Hypotension, Research, Pharmaceutical industry

This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.

Key Points: 
  • This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.
  • Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide.
  • These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients."
  • This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide.

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

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星期三, 一月 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

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星期三, 七月 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 ®.

2022 U.S. Coagulation Testing Market Report: Identify and Evaluate Emerging Business Opportunities - ResearchAndMarkets.com

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星期二, 十一月 1, 2022
Research, Managed Care, General Health, Medical Devices, Hospitals, Health Technology, Clinical Trials, Science, Surgery, Biotechnology, Other Science, Health, ACT, Factor VII, Factor XII, Factor, Factor XI, Factor IX, APTT, Protein S, Activated protein C resistance, Thrombin time, Antithrombin, Bleeding time, Protein C, Factor X, Prothrombin time, Consumables, Factor V, Factor VIII, Prekallikrein, Comparison, Factor XIII, Fibrinogen, Marketing, Retail, Vaccine, Fine chemical, Pharmaceutical industry, Plasmin

The "2022 U.S. Coagulation Testing Market - Analyzers and Consumables - Supplier Shares, Segment Volume and Sales Forecasts for over 40 Assays, Opportunities" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "2022 U.S. Coagulation Testing Market - Analyzers and Consumables - Supplier Shares, Segment Volume and Sales Forecasts for over 40 Assays, Opportunities" report has been added to ResearchAndMarkets.com's offering.
  • This comprehensive report is designed to help current suppliers and potential market entrants identify and evaluate emerging business opportunities in the US coagulation testing market during the next five years.
  • The report is available by section, and can be customized to specific information needs and budget.
  • The report explores business and technological trends in the US coagulation testing market; provides estimates of the test volume, as well as sales and market shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.

Innovative Smartphone and Artificial Intelligence-Based Tests Featured at the 2022 AACC Annual Scientific Meeting

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星期二, 七月 26, 2022
People, Mayo Clinic, Algorithm, Diagnosis, Time, INR, University, Urinary tract infection, MPH, Physician, Laboratory, Biostatistics, Research, Bleeding, Smartphone, Doctor of Philosophy, Data science, Health, Salt, Information technology, Fourier, MLS, Artificial intelligence, Risk, Diet, Kidney, Animal testing at the University of Washington, Movement, ASCP, Technology, MD, Patient, Blood, Pain, University of Washington Medical Center, Prothrombin time, Warfarin, Mayo, Mineral, AI, Medical device, FTIR

CHICAGO, July 26, 2022 /PRNewswire/ -- Scientists have developed a cheap, convenient smartphone test for monitoring patients at risk for dangerous blood clots.

Key Points: 
  • CHICAGO, July 26, 2022 /PRNewswire/ -- Scientists have developed a cheap, convenient smartphone test for monitoring patients at risk for dangerous blood clots.
  • Research demonstrating that this test works, along with a second study on using artificial intelligence (AI) to improve testing and treatment for people with kidney stones, will be presented at the 2022 AACC Annual Scientific Meeting & Clinical Lab Expo.
  • A team led by Kelly Michaelsen, MD, PhD, of the University of Washington developed a test that quickly and inexpensively determines PT/INR using a smartphone.
  • AACC Annual Scientific Meeting registration is free for members of the media.

Romidepsin for Injection Available from Fresenius Kabi

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星期二, 七月 12, 2022
Oncology, Medical Supplies, Health, Medical Devices, General Health, Pharmaceutical, Biotechnology, DNA virus, Infection, Nausea, Purging disorder, Thrombocytopenia, HDAC, T-cell lymphoma, Itch, INR, LLC, Birth, Neutropenia, Multimedia, Anemia, Potassium, History, CYP3A4, Risk, Hepatitis B, Patient, CEO, ECG, Fetus, Adult, Tumor lysis syndrome, Hepatitis, Cardiovascular disease, Leukopenia, CTCL, Injection, Pulmonary toxicity, Rifampicin, Toxicity, DNA, Fresenius (company), Lymphocytopenia, Fatigue, Warfarin, FDA, Magnesium, Constipation, Vomiting, Cancer, Prothrombin time, Female, Pharmaceutical industry, Vaccine, Medical imaging, Birth control, Romidepsin, Dysgeusia

Fresenius Kabi announced today the immediate availability in the United States of Romidepsin for Injection, the newest addition to the companys broad portfolio of injectable oncology medicines.

Key Points: 
  • Fresenius Kabi announced today the immediate availability in the United States of Romidepsin for Injection, the newest addition to the companys broad portfolio of injectable oncology medicines.
  • View the full release here: https://www.businesswire.com/news/home/20220712005418/en/
    Fresenius Kabi Romidepsin for Injection is the first approved generic equivalent for ISTODAX, providing clinicians and patients with a more affordable treatment option.
  • (Photo: Business Wire)
    Fresenius Kabi Romidepsin for Injection is the first approved generic equivalent for ISTODAX, providing clinicians and patients with a more affordable treatment option.
  • Fresenius Kabi Romidepsin is supplied as a kit including one 10 mg single-dose vial of Romidepsin and one 2.2 mL vial of diluent.

Intercept Announces Closing of Transaction with Advanz Pharma to Transfer Rights to Commercialize Ocaliva® for PBC Outside the U.S.

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星期五, 七月 1, 2022
FDA, Constipation, Warfarin, NASH, Patient, LinkedIn, Liver, Colesevelam, Adult, Hepatotoxicity, Abdominal pain, Colestipol, Theophylline, Fatty liver disease, BSEP, INR, GLOBE, CYP1A2, OCA, Population, Prothrombin time, Failure, Alkaline phosphatase, Bilirubin, Primary biliary cholangitis, Rash, Hyperlipidemia, MHRA, Jaundice, Obeticholic acid, UDCA, FXR, Bile, Intercept Pharmaceuticals, EMA, Intercept, Therapy, Autoimmune hepatitis, Ciclosporin, Arthralgia, Dizziness, Fatigue, Absorption, Survival, Nasdaq, Sleep, Ascites, ALP, Cirrhosis, Ursodeoxycholic acid, FLS, Hepatic encephalopathy, Dermatitis, Twitter, Alcoholic liver disease, PBC, Itch, Pharmaceutical industry, Vaccine, Medical imaging, Dietary supplement, Generic drug, Advanz Pharma

As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.

Key Points: 
  • As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.
  • Upfront consideration for the transaction is $405 million, subject to working capital, closing costs, France reimbursement liability and other adjustments.
  • OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
  • OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.

ProPhase Labs Announces Significant Laboratory Expansion

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星期一, 六月 13, 2022
DNA sequencing, NGS, TK, Whole genome sequencing, Company, Hemostasis, Research, Marketing, Food, Genetic, Immunoassay, OTC, Hematology, Platelet, Genetics, CLIA, RNA, Environment, Nebula Genomics, Failure, COVID-19 testing, Nasdaq, Gene, Urine test strip, Physician, GLOBE, FDM, Bleeding time, Private Securities Litigation Reform Act, RT-PCR, DNA, Laboratory, Media relations, PCR, COVID-19, Prothrombin time, Risk, Prophase, Chromosome, Acquisition, NASDAQ, SEC, Severe acute respiratory syndrome coronavirus 2, Institution, Inherited disorders of trafficking, Heart, Thromboplastin, Dietary supplement, Genomics, WGS, University, Antibiotics, Pharmaceutical industry, Blood product, Vaccine

Garden City, NY, June 13, 2022 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified diagnostics and genomics company, today announced that it has partnered with world-renowned healthcare diagnostics innovators for new clinical chemistry, immunoassay, hematology, hemostasis and urinalysis analyzers as part of its plan to significantly expand its in-house clinical testing capabilities. State-of-the-art clinical testing equipment has been procured and a new lease executed for additional space at the company’s corporate headquarters in Garden City, New York. Plans are also under way to expand the company’s in-house genomics testing offerings.

Key Points: 
  • ProPhase Labs relocated to its current headquarters in January 2021 and built from scratch a 25,000 square foot state-of-the-art CLIA certified laboratory to support the companys growing COVID-19 testing franchise.
  • Ted Karkus, ProPhase Labs Chief Executive Officer, commented, We are very excited to broaden ProPhases testing capabilities at our Garden City headquarters.
  • ProPhase Diagnostics, Inc. (ProPhase Diagnostics), a wholly-owned subsidiary of ProPhase, offers a broad array of clinical diagnostic and testing services at its CLIA certified laboratories including state-of-the-art polymerase chain reaction (PCR) testing for SARS-CoV-2 (COVID-19).
  • ProPhase Precision Medicine, Inc. (ProPhase Medicine), a wholly-owned subsidiary of ProPhase, focuses on genomics testing technologies, a comprehensive method for analyzing entire genomes, including the genes and chromosomes in DNA.

Global Coagulation Testing Lab and POC Market (2022 to 2026) - Analysis of Current and Emerging Technologies and Their Potential Market Applications - ResearchAndMarkets.com

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星期二, 四月 26, 2022
Health, Medical Devices, Cardiology, ACT, Computer, Factor VII, Factor IX, APTT, Thrombin time, Factor XIII, Coagulation, Heparin-induced thrombocytopenia, Fibrinogen, Protein C, The Queen's Award for Enterprise: Innovation (Technology) (2011), Bleeding time, Factor, Activated protein C resistance, Factor X, Prothrombin time, Factor VIII, Prekallikrein, Factor V, Antithrombin, POC, Protein S, Factor XII, Factor XI, Fine chemical, Plasmin

The "2022-2026 Global Coagulation Testing Lab and POC Market: US, Europe, Japan--Supplier Sales and Shares, Volume and Sales Segment Forecasts, Competitive Strategies, Innovative Technologies, Instrumentation Review" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "2022-2026 Global Coagulation Testing Lab and POC Market: US, Europe, Japan--Supplier Sales and Shares, Volume and Sales Segment Forecasts, Competitive Strategies, Innovative Technologies, Instrumentation Review" report has been added to ResearchAndMarkets.com's offering.
  • This comprehensive seven-country report is designed to help current suppliers and potential market entrants identify and evaluate business opportunities emerging in the global coagulation testing market during the next five years.
  • New specific and sensitive markers of coagulation will be increasingly used on automated instrumentation.
  • Coagulation testing will also become more standardized, offering opportunities for quality control products and services.

WebCareHealth provides safe alternative to address national crisis on shortage of Blue Top Collection Tubes used to test coagulation

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星期一, 六月 28, 2021
Blood tests, Prothrombin time, Monitor, Telehealth, Health, Medical monitoring

CoagMgr from the WebCareHealth platform is a unique streamlined, web-based model for managing at-home INR (International Normalized Ratio) patients .

Key Points: 
  • CoagMgr from the WebCareHealth platform is a unique streamlined, web-based model for managing at-home INR (International Normalized Ratio) patients .
  • It is designed so health care providers can work directly with patients to more easily monitor and adjust dosages in real time.
  • "WebCareHealth recognizes the current need for urgent solutions and is committed to relieving this crisis by offering our safe in-home INR testing approach, CoagMgr .
  • Founded in 2014 WCH develops innovative cloud-based software solutions that enable healthcare providers to remotely monitor the health of patients managing chronic illnesses.