This material may not be published, broadcast, rewritten, or redistributed. Show Caption Previous Next INDIANAPOLIS — The Indiana National Guard is awaiting new lab results to determine if pinworm has infected soldiers training in Fort Knox, Kentucky and Camp Atterbury, which is near Edinburgh, Indiana. The Centers for Disease Control says a pinworm can lead people to complain about teeth grinding, and insomnia due to disturbed sleep, or even abdominal pain or appendicitis. RTV6 has been receiving emails from the families of soldiers since Monday. All asked to remain anonymous out of fear that their family member could get in trouble if they spoke out. One family has medicine on standby once her child returns home. The parent said a doctors appointment is set up for next week. In a statement posted on Facebook, the National Guard said test results show no confirmed diagnosis of pinworm at Fort Knox or Camp Atterbury. Pinworm is an intestinal infection.
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Portola is seeking conditional approval of IndexXa in the EU through the centralized procedure. With the acceptance of the application, the EMAs Committee for Medicinal Products for Human Use (CHMP) will now begin the centralized review procedure under a standard 210-day review period. An estimated 73,000 patients treated with an oral Factor Xa inhibitor will be hospitalized this year due to major bleeding or because they require urgent surgery in the EU5i. These patients are critically ill and could potentially benefit from a Factor Xa inhibitor antidote, said Bill Lis, chief executive officer of Portola. As there is currently no approved antidote for Factor Xa inhibitors in the EU, we are working diligently to bring IndexXa to patients. The MAA validation is an important milestone toward achieving that goal. Portolas MAA submission is based on data from two Phase 3 ANNEXA studies that evaluated the safety and efficacy of andexanet alfa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers. Results of the ANNEXA studies were published by The New England Journal of Medicine. The MAA also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study. Portola is currently evaluating andexanet alfa in this global, Phase 3b/4 single-arm, open-label study in http://www.aprasw.org/wwwaprasworg9564/2016/08/05/%c2%94-the-study-was-a-collaboration-between-the-psychology-department-at-american-university-in-washington-d/ patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed. The study is enrolling patients in the United States, Canada and the EU. On August 17, 2016, Portola received a Complete Response Letter (CRL) from the U.S.
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