The approval of Retacrit was based on a review of evidence that included human pharmacokinetic/pharmacodynamic data and clinical immunogenicity data which demonstrated a high degree of similarity between Retacrit and its reference product.
Andexxa, a recombinant modified human Factor Xa (FXa) protein, was approved under the FDA's Accelerated Approval pathway.
In this meta-analysis of prospective population-based studies, sickle cell trait (SCT) was not associated with any difference in risk of first ischemic stroke.
To examine the occurrence of adverse reactions in this patient population, researchers from John Hopkins University, Baltimore, Maryland, conducted a retrospective analysis of IBD patients who received IV iron infusions between 2010 and 2014 in the commercial claims database, MarketScan.
The safety and efficacy of LentiGlobin were evaluated in 2 independent 2-year clinical studies: HGB-204 (Northstar, N=18), an open-label, single-dose, nonrandomized, multicenter Phase 1/2 study in patients with TDT, and HGB-205, an ongoing open-label, single-dose, nonrandomized, single-center Phase 1/2 study in patients with TDT and severe sickle cell disease.
The trial enrolled 152 patients with hemophilia A who were previously treated, either on-demand or as prophylaxis, with factor VIII therapy.
Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). In addition, there was a low late of thrombotic events and no new safety events were reported.
Safety and efficacy of Vonvendi with or without recombinant factor VIII (FVIII) treatment in elective surgical procedures in patients aged ≥18 years diagnosed with severe von Willebrand disease, was established in the Phase 3 trial.
The recall notification is due to a potential risk of breakage of the glass vials during transport because of a change in the secondary packaging configuration.
Researchers from Beijing University of Chinese Medicine and the Catalan Health Institute, Spain sought to investigate the effects of oral vitamin B12 vs. IM vitamin B12 to determine whether outcomes for vitamin B12 deficient patients would differ based on the formulation.
Using Medicaid claims from 5 states (1999-2010) and Medicare claims for dual-enrollees, study authors analyzed the first concomitant use of clopidogrel and 1 of 10 selected NSAIDs (ibuprofen, celecoxib, naproxen, rofecoxib, meloxicam, diclofenac, indomethacin, valdecoxib, nabumetone, etodolac) after a 1-year baseline period.
ANNEXA-4 is a global, single-arm, open-label clinical trial designed to evaluate andexanet alfa in patients who present with an acute major bleed while receiving apixaban, rivaroxaban, edoxaban or enoxaparin.
The myPKFiT software can be used to generate Advate dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16yrs of age and older and body weight of 45kg or greater.
The primary endpoint was the number of patients who required no platelet transfusion priory to primary invasive procedure and no rescue therapy for bleeding for 7 days post-procedure.
Results found that those who received a subcutaneous administration of 300mg lanadelumab once every 2 weeks had an 87% reduction in mean frequency of HAE attacks.
The researchers found that the MFS/ATR1a-null mice showed unabated aortic root enlargement and remained responsive to losartan, despite being hypotensive and resistant to AngII vasopressor effects.
Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate with an extended half-life, was approved by the Food and Drug Administration (FDA) in May 2017.
Data were included for 2,821 children with 5,014 person-years. The researchers found that 18 percent of children received ≥300 days of antibiotics.
The Food and Drug Administration broadened the existing labeling for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication.
After completion of the initial bevacizumab treatment cycle, there was a significant reduction in epistaxis severity scores and RBC transfusion requirements.
At 90 days, the prevalence of venous thromboembolism varied from 0.3 to 1.37% for all patients and from 0.75 to 3.86% for hospitalized patients.