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Oral Anticoagulant Articles & Analysis

14 news found

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention with the goal to reduce clot formation while leaving the body’s ability to respond to bleeding intact. ...

ByBayer AG


New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA

New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA

Avoiding worsening renal function is an important clinical consideration beyond stroke prevention when it comes to the selection of an oral anticoagulant in patients with NVAF. The XARENO study was undertaken to investigate the real-world effectiveness and safety of Xarelto compared with VKAs in this vulnerable patient group with NVAF and advanced CKD. ...

ByBayer AG


Bayer progressing well with transformation of pharma business and raises peak sales potential of key growth drivers to over twelve billion euros

Bayer progressing well with transformation of pharma business and raises peak sales potential of key growth drivers to over twelve billion euros

A step-change in growth is expected from oral factor XIa (FXIa) inhibitor asundexian. With the potential to act as distinct option for the prevention of thrombosis and ischemic strokes, asundexian has projected peak sales of more than five billion euros. It is estimated that around 40 percent of eligible patients are either not treated with direct oral ...

ByBayer AG


Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

” “We have had significant advances for our patients requiring anticoagulation with the introduction of the direct oral anticoagulants. But we still have patients who do not get the therapy, or for whom there is a need for alternative treatment options in thrombosis prevention,” said Manesh Patel, Richard S. ...

ByBayer AG


Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation

Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation

The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. ...

ByBayer AG


CytoSorbents to Present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum and Jefferies London Healthcare Conference

CytoSorbents to Present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum and Jefferies London Healthcare Conference

The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit ...

ByCytoSorbents Corporation


CytoSorbents To Expand Direct Sales of CytoSorb to the United Kingdom, the Sixth Largest Medical Device Market in the World

CytoSorbents To Expand Direct Sales of CytoSorb to the United Kingdom, the Sixth Largest Medical Device Market in the World

The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit ...

ByCytoSorbents Corporation


CytoSorbents Receives Approximately $740,000 from the New Jersey Business Tax Certificate Transfer Program

CytoSorbents Receives Approximately $740,000 from the New Jersey Business Tax Certificate Transfer Program

The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit ...

ByCytoSorbents Corporation


U.S. FDA approves Xarelto to treat venous thromboembolism (VTE) and to prevent VTE in children

U.S. FDA approves Xarelto to treat venous thromboembolism (VTE) and to prevent VTE in children

Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age Convenient liquid formulation advances standard of care for children; alleviates administration ...

ByBayer AG


CytoSorbents Appoints Daniel Wendt, MD, PhD, MHBA, FECTS as Vice President, Medical Affairs Cardiovascular

CytoSorbents Appoints Daniel Wendt, MD, PhD, MHBA, FECTS as Vice President, Medical Affairs Cardiovascular

The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit ...

ByCytoSorbents Corporation


CytoSorbents Announces Publication of U.S. CTC Multicenter Registry Results Using CytoSorb in Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO)

CytoSorbents Announces Publication of U.S. CTC Multicenter Registry Results Using CytoSorb in Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO)

The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit ...

ByCytoSorbents Corporation


First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

Following the granting of a second Breakthrough Designation for the removal of apixaban and rivaroxaban, we recently received full FDA approval of our IDE application to conduct the Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) trial, a second, very similar study that will leverage the existing infrastructure of STAR-T. ...

ByCytoSorbents Corporation


CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

” In August 2021, the FDA granted CytoSorbents Breakthrough Device Designation to remove the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the risk of serious bleeding during urgent cardiothoracic surgery, recognizing this major unmet medical need. ...

ByCytoSorbents Corporation


CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, rivaroxaban and apixaban, in a cardiopulmonary bypass circuit ...

ByCytoSorbents Corporation

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