Real-world bleeding risk with ibrutinib

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Ibrutinib (Imbruvica)
Photo courtesy of Janssen
The Bruton tyrosine kinase inhibitor ibrutinib has been linked to a 20-fold increased risk of major bleeding in blood cancer patients taking concomitant antiplatelet and anticoagulation therapy in a clinical setting. Caution should be used when weighing the risks and benefits of ibrutinib for patients already taking antiplatelet or... [Read Article]
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Health Canada approves emicizumab

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Emicizumab (Hemlibra)
Photo from Business Wire
Health Canada has approved emicizumab (Hemlibra®) for use as routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients with factor VIII inhibitors. Emicizumab is a bispecific factor IXa- and factor X-directed antibody. It bridges activated factor IX and factor X to restore the natural function of... [Read Article]
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FA pathway key to DNA repair after CRISPR cutting

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DNA repair
Image by Tom Ellenberger
New research suggests the Fanconi anemia (FA) pathway plays a key role in repairing double-strand breaks (DSBs) created by CRISPR-Cas9 genome editing. Researchers said they found that Cas9-induced single-strand template repair requires the FA pathway, and the protein FANCD2 localizes to Cas9-induced DSBs. The team said this research provides... [Read Article]
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CHMP recommends expanded approval for rivaroxaban

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Prescription drugs
Photo courtesy of the CDC
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for rivaroxaban (Xarelto) 2.5 mg tablets. The recommendation is for rivaroxaban co-administered with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adults with coronary artery disease or symptomatic peripheral... [Read Article]
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Depression, antidepressants linked to VTE

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Prescription drugs
Photo courtesy of the CDC
Depression and the use of antidepressants are each associated with an increased risk of venous thromboembolism (VTE), according to a review and meta-analysis published in Annals of Medicine. The research also showed that each of the various classes of antidepressant medications is associated with an increased risk of... [Read Article]
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Turbulence aids platelet production

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Megakaryocytes in the bone marrow
Turbulence promotes large-scale production of functional platelets from human induced pluripotent stem cells (hiPSCs), according to research published in Cell. Exposure to turbulent energy in a bioreactor stimulated hiPSC-derived megakaryocytes to produce 100 billion platelets. Transfusion of these platelets in 2 animal models promoted blood clotting and prevented bleeding just... [Read Article]
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FDA releases guidance docs on gene therapy

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DNA helix
Image by Spencer Phillips
The US Food and Drug Administration (FDA) has released several draft guidance documents on gene therapy. Three are disease-specific guidances—for hemophilia, rare diseases, and retinal disorders—and 3 are guidances on manufacturing gene therapies. These 6 documents are intended to serve as the building blocks of a modern, comprehensive framework... [Read Article]
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Lower risk of bleeding with apixaban

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Apixaban (Eliquis)
Photo from Pfizer/
Bristol Myers Squibb
Real-world data suggest that apixaban poses a lower risk of bleeding than warfarin, but patients who receive lower doses of apixaban have an increased risk of all-cause mortality. Compared to warfarin, apixaban was associated with a decreased risk of major bleeding, intracranial bleeding, and gastrointestinal bleeding in... [Read Article]
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CHMP recommends rVWF for VWD

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US version of rVWF (Vonvendi)
Photo from Shire
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for vonicog alfa (VEYVONDI), a recombinant von Willebrand factor (rVWF) product. The CHMP is recommending vonicog alfa for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (age... [Read Article]
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CHMP backs approval of caplacizumab

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Vials of drug
Photo by Bill Branson
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of caplacizumab (Cablivi) for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP). Caplacizumab is a humanized bivalent nanobody that inhibits the interaction between von Willebrand factor and platelets. The CHMP’s... [Read Article]
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Survey reveals patient perceptions of ITP

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Poster session at the 23rd
Congress of the European
Hematology Association (EHA)
Photo from EHA
A new survey has revealed patients’ perceptions of immune thrombocytopenia (ITP) and how the condition impacts their quality of life (QOL). Patients reported delays in diagnosis, lack of support, severe fatigue, and impacts on both emotional well-being and their ability... [Read Article]
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Drug is convenient alternative for PNH, doc says

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Session at the 23rd
Congress of the European
Hematology Association (EHA)
Photo from EHA
Results of a phase 3 study suggest the long-acting C5 complement inhibitor ravulizumab produces similar results as eculizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH). Treatment with ravulizumab every 8 weeks proved noninferior to treatment with eculizumab every 2 weeks... [Read Article]
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