{"id":22821,"date":"2022-01-31T13:30:00","date_gmt":"2022-01-31T18:30:00","guid":{"rendered":"https:\/\/wfh.org\/actualites-des-entreprises-partenaires\/"},"modified":"2026-03-29T15:04:02","modified_gmt":"2026-03-29T19:04:02","slug":"actualites-des-entreprises-partenaires","status":"publish","type":"page","link":"https:\/\/wfh.org\/fr\/partenaires\/actualites-des-entreprises-partenaires\/","title":{"rendered":"Actualit\u00e9s des Entreprises partenaires"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"22821\" class=\"elementor elementor-22821 elementor-22501\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d309f2 elementor-section-full_width elementor-reverse-mobile elementor-section-height-default elementor-section-height-default\" data-id=\"6d309f2\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-235ecc5 elementor-hidden-mobile\" data-id=\"235ecc5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4cd5560 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"4cd5560\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;sticky_offset&quot;:100,&quot;sticky_effects_offset&quot;:100,&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-025b70d\" data-id=\"025b70d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f61b6c elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2f61b6c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/wfh.org\/fr\/partenaires\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-arrow-left\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">PARTENAIRES<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-da996fe\" data-id=\"da996fe\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2847bfb elementor-widget elementor-widget-template\" data-id=\"2847bfb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"section\" data-elementor-id=\"25309\" class=\"elementor elementor-25309 elementor-25306 elementor-25306\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4897f92e elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"4897f92e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-75983c78\" data-id=\"75983c78\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-21504386 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"21504386\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-7ba5d59b\" data-id=\"7ba5d59b\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f85140c elementor-widget elementor-widget-spacer\" data-id=\"4f85140c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-201d71a elementor-widget elementor-widget-heading\" data-id=\"201d71a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Actualit\u00e9s des Entreprises partenaires<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18436e2 elementor-widget elementor-widget-text-editor\" data-id=\"18436e2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Cette section du site Internet de la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) est r\u00e9serv\u00e9e aux laboratoires pharmaceutiques fabricant des m\u00e9dicaments et autres produits traitant les troubles de la coagulation afin de diffuser les communiqu\u00e9s de presse susceptibles d\u2019int\u00e9resser les membres de notre communaut\u00e9.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-79b579f elementor-section-full_width clamp_p elementor-section-height-default elementor-section-height-default\" data-id=\"79b579f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-261730a\" data-id=\"261730a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-0428ecb\" data-id=\"0428ecb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-def450f clamp_p elementor-widget elementor-widget-text-editor\" data-id=\"def450f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La FMH ne cautionne en aucun cas les informations diffus\u00e9es dans la pr\u00e9sente section et ne soutient aucune alternative th\u00e9rapeutique en particulier. Les d\u00e9clarations et les opinions exprim\u00e9es ici ne refl\u00e8tent en aucun cas ni le point de vue, ni la politique de la FMH et ne constituent en aucun cas des recommandations de sa part.<\/p>\n<p><em>Les communiqu\u00e9s de presse des entreprises partenaires sont disponibles uniquement en anglais.<\/em><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc3e9f7 elementor-widget elementor-widget-html\" data-id=\"bc3e9f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>\r\n.tab {\r\n  overflow: auto;\r\n  white-space: nowrap;\r\n  border: 1px solid #ccc;\r\n  background-color: #f1f1f1;\r\n  font-size: 0;\r\n}\r\n\r\n\/* Style the buttons inside the tab *\/\r\n.tab button {\r\n  display: inline-block;\r\n  border: none;\r\n  border-radius: 0;\r\n  color: #ec174c;\r\n  outline: none;\r\n  cursor: pointer;\r\n  padding: 14px 20px;\r\n  transition: 0.3s;\r\n  font-size: clamp(16px, 1.4vw, 18px) !important;\r\n  line-height: clamp(18px, 1.5vw, 20px) !important;\r\n  font-weight: bold;\r\n}\r\n\r\n\/* Change background color of buttons on hover *\/\r\n.tab button:hover {\r\n  background-color: #ddd;\r\n}\r\n\r\n\/* Create an active\/current tablink class *\/\r\n.tab button.active {\r\n  background-color: #ccc;\r\n  background-image: linear-gradient(90deg, var(--e-global-color-secondary) 0%, var(--e-global-color-238b721) 100%);\r\n  color: #ffffff!important;\r\n}\r\n\r\n\/* Style the tab content *\/\r\n.tabcontent {\r\n  display: none;\r\n  padding: 6px 12px;\r\n  border: 1px solid #ccc;\r\n  border-top: none;\r\n}\r\n<\/style>\r\n\r\n\r\n\r\n<div class=\"tab\">\r\n    \r\n   <button class=\"tablinks active\" onclick=\"openPR(event, 'pr2026')\">2026 PRESS RELEASES<\/button>    \r\n  <button class=\"tablinks\" onclick=\"openPR(event, 'pr2025')\">2025<\/button>\r\n  <button class=\"tablinks\" onclick=\"openPR(event, 'pr2024')\">2024<\/button>\r\n  <button class=\"tablinks\" onclick=\"openPR(event, 'pr2023')\">2023<\/button>\r\n  <button class=\"tablinks\" onclick=\"openPR(event, 'pr2022')\">2022<\/button>\r\n  <button class=\"tablinks\" onclick=\"openPR(event, 'pr2021')\">2021<\/button>\r\n  <button class=\"tablinks\" onclick=\"openPR(event, 'pr2020')\">2020<\/button>\r\n<\/div>\r\n\r\n<div id=\"pr2026\" class=\"tabcontent\" style=\"display:block\">\r\n  <p>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"166826\" class=\"elementor elementor-166826\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-248d0215 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"248d0215\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7248fb8c\" data-id=\"7248fb8c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f773593 elementor-widget elementor-widget-text-editor\" data-id=\"2f773593\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Temporary global stockout of etranacogene dezaparvovec-drlb (Hemgenix)<\/strong><\/p><p>March 17, 2026 \u2014 CSL is reporting a a temporary global stockout of etranacogene dezaparvovec-drlb (Hemgenix) gene therapy that will result in delays in treatment for some individuals in countries with established commercial access. This situation is not related to the safety or effectiveness of etranacogene dezaparvovec-drlb. CSL is working with regulatory authorities on strategies to ensure stable ongoing supply of the treatment while preserving high quality standards. <a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2026\/03\/Final_International-HEMGENIX-Supply-Community-Letter-for-Distribution.pdf\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p style=\"font-weight: 400;\"><strong><br \/>The European Commission grant EU marketing authorization for Veyvondi (vonicog alfa) for VWD<\/strong><\/p><p style=\"font-weight: 400;\">January 13, 2026 &#8211; The European Commission has granted EU marketing authorization for Veyvondi (vonicog alfa), a treatment in von Willebrand disease (VWD), expanding its indication to include pediatric patients. Children with VWD face the ongoing risk of spontaneous bleeding, such as frequent nosebleeds, heavy or prolonged menstrual bleeding and easy bruising. <a href=\"https:\/\/www.linkedin.com\/posts\/takeda-pharmaceuticals_we-are-thrilled-to-announce-that-the-european-activity-7416781115824168960-wGfw\/?utm_source=share&amp;utm_medium=member_desktop&amp;rcm=ACoAAAAyQiwBAMBYQ30Jh2f6PP3QbOS3coHgZ1U\" target=\"_blank\" rel=\"noopener\" data-outlook-id=\"866b42f2-9025-44cb-ba2f-ca6e678ea2fc\">LINK<\/a><\/p><hr \/>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/p>\r\n<\/div>\r\n\r\n<div id=\"pr2025\" class=\"tabcontent\">\r\n  <p>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"134706\" class=\"elementor elementor-134706\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-248d0215 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"248d0215\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7248fb8c\" data-id=\"7248fb8c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f773593 elementor-widget elementor-widget-text-editor\" data-id=\"2f773593\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n\n<strong>\nSanofi\u2019s Fitusiran approved in China<\/strong>\nDecember 11, 2025 &#8211; The National Medical Products Administration (NMPA) in China has approved fitusiran for hemophilia. Fitusiran is the first antithrombin-lowering therapy for hemophilia and can offer consistent protection with as few as six injections a year. <a href=\"https:\/\/finance.yahoo.com\/news\/press-release-sanofi-qfitlia-cablivi-060000645.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nData published in the New England Journal of Medicine confirm long-term durability and safety of etranacogene dezaparvovec-drlb\n<\/strong>December 7, 2025 \u2014CSL has announced the five-year (60-month) results from the Phase 3 HOPE-B study, confirming the long-term durability and safety of a one-time infusion of etranacogene dezaparvovec-drlb in adults living with hemophilia B. Published in the New England Journal of Medicine (NEJM) and presented simultaneously at the American Society of Hematology (ASH) Annual Meeting, the data reaffirm etranacogene dezaparvovec-drlb\u2019s consistent performance over time to deliver durable factor IX activity levels, sustained bleed protection compared to prophylaxis treatment, and continued freedom from routine prophylaxis. The treatment remains the only commercially available gene therapy for adults with hemophilia B and can be used in patients with or without AAV5 neutralizing antibodies. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/data-published-in-the-new-england-journal-of-medicine-confirm-the-long-term-durability-and-safety-of-hemgenix-etranacogene-dezaparvovec-drlb-over-five-years-302634803.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nSar Therapeutics Announces Oversubscribed $125 Million Series D Financing<\/strong>\nSeptember 30, 2025 \u2014 Star Therapeutics Announces Oversubscribed $125 Million Series D Financing. Proceeds will go to support the continued clinical advancement of the lead program, VGA039, a first-in-class antibody targeting protein S for the treatment of bleeding disorders, starting with von Willebrand disease (VWD). VGA039 is the first subcutaneous therapy, dosed once monthly, that can address all types of VWD and all types of bleeds. A pivotal Phase 3 trial of VGA039 in VWD patients has been initiated. <a href=\"https:\/\/finance.yahoo.com\/news\/star-therapeutics-announces-oversubscribed-125-103000794.html?guccounter=1&amp;guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNhLw&amp;guce_referrer_sig=AQAAAET0YwX8QKfifpnANaXupPL_w6pZFeTxJtFURH7RSENTv4omt6coP4HHW1UyZFBHjJcL2nMEVivcZHA_ZnF2wSswXX-aQXoKZF_U-KTQ9uWkQtfSTM4LF0uTG9RgJew1_mRtAQ220ud8t5MUc2Vx14VAmfIt6Jh3OFpF202xoXT_\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nU.S. FDA approves expanded indication for von Willebrand factor (Recombinant) for adults and children with von Willebrand disease\n<\/strong>September 5, 2025 \u2014 Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for von Willebrand factor (Recombinant), expanding the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with von Willebrand disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. Von Willebrand factor (Recombinant) was previously approved for on-demand and perioperative use in adults with VWD and routine prophylactic use in adults with severe Type 3 VWD receiving on-demand therapy. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-expanded-use-vonvendi-von-willebrand-disease-including-certain-uses-children?utm_medium=email&amp;utm_source=govdelivery&amp;utm_source=sfmc&amp;utm_medium=email&amp;utm_campaign=FDA+Alert+9.8.2025&amp;utm_term=https%3a%2f%2fwww.fda.gov%2fnews-events%2fpress-announcements%2ffda-approves-expanded-use-vonvendi-von-willebrand-disease-including-certain-uses-children%3futm_medium%3demail%26utm_source%3dgovdelivery&amp;utm_id=479325&amp;sfmc_id=19304377\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nFDA approves concizumab-mtci to prevent or reduce the frequency of bleeding episodes for hemophilia\n<\/strong>July 31, 2025 \u2014 The US Food and Drug Administration (FDA) has approved concizumab-mtci as a once-daily prophylactic subcutaneous injection treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B without inhibitors. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/fda-approves-alhemo-as-once-daily-prophylactic-treatment-to-prevent-or-reduce-the-frequency-of-bleeding-episodes-for-adults-and-children-12-years-of-age-and-older-with-hemophilia-a-or-b-hahb-without-inhibitors-302519177.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nPfizer announces positive topline Phase 3 Results for marstacimab in hemophilia A or B with inhibitors\n<\/strong>June 26, 2025 \u2014 Pfizer Inc. has announced positive topline results from the Phase 3 BASIS study evaluating marstacimab for adults and adolescents living with hemophilia A or B with inhibitors. The study met the primary endpoint and key secondary bleeding endpoints demonstrating the superiority of once-weekly subcutaneous marstacimab injections in improving key bleeding outcomes compared to on-demand treatment in a patient population where less burdensome treatment approaches are needed. <a href=\"https:\/\/www.businesswire.com\/news\/home\/20250626097323\/en\/Pfizer-Announces-Positive-Topline-Phase-3-Results-for-HYMPAVZI-in-Hemophilia-A-or-B-with-Inhibitors\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nNXT007 may have potential to provide hemostatic normalization in people with hemophilia A\n<\/strong>June 23, 2025 \u2014 Roche announced today positive phase I\/II data on NXT007\u2014a next-generation bispecific antibody\u2014in people with hemophilia A, supporting its progression into phase III clinical development. Early data from the NXTAGE study suggest that NXT007 may have the potential to provide hemostatic normalization in people with hemophilia A. This positive phase I\/II data was presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress. <a href=\"https:\/\/www.globenewswire.com\/news-release\/2025\/06\/23\/3103084\/0\/en\/Early-data-suggest-Roche-s-NXT007-may-have-the-potential-to-provide-haemostatic-normalisation-in-people-with-haemophilia-A.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nBelief BioMed and Takeda China jointly announce official approval of Dalnacogene Ponparvovec Injection, China\u2019s first hemophilia B gene therapy\n<\/strong>April 10, 2025 \u2014 The World Federation of Hemophilia (WFH) is currently following a recent gene therapy development in China. Belief BioMed and Takeda China have jointly announced that Dalnacogene Ponparvovec Injection has been officially approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with moderate to severe hemophilia B (congenital coagulation factor IX deficiency) in China. The WFH will keep our community informed as new developments are shared. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/belief-biomed-and-takeda-china-jointly-announced-bbm-h901-dalnacogene-ponparvovec-injection-chinas-first-hemophilia-b-gene-therapy-was-officially-approved-302425572.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\nTo read the ASH Publications article, \u201cEfficacy and Safety of an Engineered, Liver-Tropic Adeno-Associated Virus Vector Expressing Factor IX Padua Administered with Prophylactic Glucocorticoids in Patients with Hemophilia B: A Multi-Center, Single-Arm, Phase 3 Trial\u201d, please <a href=\"https:\/\/ashpublications.org\/blood\/article\/144\/Supplement%201\/3582\/530142\/Efficacy-and-Safety-of-an-Engineered-Liver-Tropic\" target=\"_blank\" rel=\"noopener\">click here<\/a>.\n\n<hr \/>\n\n<strong>\nFitusiran approved as the first therapy in the U.S.A to treat hemophilia A or B with or without inhibitors\n<\/strong>March 28, 2025 \u2014 The US Food and Drug Administration (FDA) has approved Fitusiran, the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-novel-treatment-hemophilia-or-b-or-without-factor-inhibitors\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<strong>\nPfizer stops commercialization of fidanacogene elaparvovec-dzkt gene therapy<br class=\"\" \/><\/strong>February 20, 2025 \u2014 Pfizer will stop global development and commercialization of fidanacogene elaparvovec-dzkt, a gene therapy treatment, because of low demand from patients and physicians. The treatment is a one-time therapy that was approved in in several countries\u2014 including the U.S.A, the E.U, Canada and Japan\u2014for the treatment of adults with moderate to severe hemophilia B. Pfizer will redirect efforts to marstacimab-hncq, an injectable drug that prevents or reduces bleeding episodes in hemophilia A or B patients aged 12 years and older. <a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/pfizer-says-it-will-end-global-development-gene-therapy-beqvez-nikkei-reports-2025-02-20\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a>.\n\n<hr \/>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/p>\r\n<\/div>\r\n\r\n<div id=\"pr2024\" class=\"tabcontent\">\r\n  <p>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"101583\" class=\"elementor elementor-101583\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-524433f8 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"524433f8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-747aaca7\" data-id=\"747aaca7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3c48f25f elementor-widget elementor-widget-text-editor\" data-id=\"3c48f25f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"clamp_p\"><strong>Sangamo Therapeutics to regain full rights to giroctocogene fitelparvovec hemophilia A gene therapy program as Pfizer exits<br class=\"\" \/>December 30, 2024 <\/strong>\u2014 Sangamo Therapeutics, Inc.\u2014a genomic medicine company\u2014announced it will regain full development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for the treatment of adults with moderately severe to severe hemophilia A that it has co-developed with, and licensed to Pfizer Inc., following a decision by Pfizer to terminate the global collaboration and license agreement between the parties. Sangamo intends to explore all options to advance the program, including seeking a potential new collaboration partner. <a href=\"https:\/\/www.businesswire.com\/news\/home\/20241230895593\/en\/Sangamo-Therapeutics-to-Regain-Full-Rights-to-Hemophilia-A-Gene-Therapy-Program-Following-Pfizer%E2%80%99s-Decision-to-Cease-Development-of-Giroctocogene-Fitelparvovec\">LINK<\/a><\/p>\n\n\n<hr \/>\n<p class=\"clamp_p\"><strong>SFDA approves concizumab-mtci for hemophilia A with inhibitors or hemophilia B with inhibitors<br class=\"\" \/>December 20, 2024 <\/strong>\u2014 The U.S. Food and Drug Administration (FDA) has approved concizumab-mtci as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B with inhibitors. Alhemo is injected subcutaneously (under the skin) daily. <a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-drug-prevent-or-reduce-frequency-bleeding-episodes-patients-hemophilia-inhibitors-or\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n\n\n<hr \/>\n<p class=\"clamp_p\"><strong>Spark Therapeutics, a member of the Roche Group, introduces a new FVIII gene therapy variant while discontinuing the phase 3 dirloctocogene samoparvovec gene therapy study<br class=\"\" \/>December 6, 2024 <\/strong>\u2014 Spark Therapeutics has announced the decision to discontinue the phase 3 study of dirloctocogene samoparvovec gene therapy, while introducing an enhanced-function Factor VIII variant, aiming to develop a durable gene therapy product. Building on the capsid technology and scientific insights from the dirloctocogene samoparvovec program, Spark plans to initiate a phase 2b clinical study of the enhanced-function variant in the second half of 2025. The phase 3 dirloctocogene samoparvovec study was stopped before any participants were dosed, and the decision was not related to safety concerns with dirloctocogene samoparvovec.<\/p>\n\n\n<hr \/>\n<p class=\"clamp_p\"><strong>European Commission approves marstacimab treatment for hemophilia A or B<br class=\"\" \/>November 20, 2024 <\/strong>\u2014 The European Commissionhas approved marstacimab\u2014developed by Pfizer\u2014for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and adolescent patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). A notable benefit of marstacimab is that it is delivered subcutaneously once weekly through a pre-filled pen or syringe.\u00a0<a href=\"https:\/\/www.businesswire.com\/news\/home\/20241120965921\/en\/European-Commission-Approves-Pfizer%E2%80%99s-HYMPAVZI%E2%84%A2-marstacimab-for-the-Treatment-of-Adults-and-Adolescents-with-Severe-Hemophilia-A-or-B-Without-Inhibitors\" target=\"_blank\" rel=\"noopener\" >LINK<\/a><\/p>\n\n\n<hr \/>\n<p class=\"clamp_p\"><strong>Centessa Pharmaceuticals announces discontinuation of SerpinPC development<br class=\"\">November 12, 2024 <\/strong>\u2014 Centessa Pharmaceuticals will discontinue the global clinical development of SerpinPC, an investigational serine protease inhibitor (SERPIN) engineered to specifically inhibit Activated Protein C (APC). SerpinPC was observed to have a favourable safety and tolerability profile; however, considering the evolving treatment and market landscape for hemophilia B, including the recent FDA approval of a similar product, Centessa decided to stop any further investment in this program. <a href=\"https:\/\/investors.centessa.com\/news-releases\/news-release-details\/centessa-pharmaceuticals-reports-financial-results-third-quarter\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n\n\n<hr \/>\n<p class=\"clamp_p\"><strong>Spark Therapeutics pauses Phase 3 dirloctocogene samoparvovec gene therapy clinical study<br class=\"\">October 16, 2024 <\/strong>\u2014 The following announcement was received by Spark:\n\u201cAfter careful consideration, Spark Therapeutics, a member of the Roche Group, has elected to pause the Phase 3 dirloctocogene samoparvovec gene therapy clinical study while we evaluate the possibility to further transform outcomes for hemophilia A patients with an adeno-associated virus (AAV) gene therapy. This pause is not related to safety concerns with dirloctocogene samoparvovec. Spark will continue to work with investigators to ensure the necessary long-term follow-up with patients who have received dirloctocogene samoparvovec. Spark is dedicated to developing gene therapies that demonstrate safety, efficacy, durability, and predictability. Spark will provide an update as soon as they are able.\u201d<\/p>\n\n\n<hr \/>\n\n<p class=\"clamp_p\"><strong>FDA approves marstacimab-hncq treatment for hemophilia A or B<br class=\"\">October 11, 2024 <\/strong>\u2014 The U.S. Food and Drug Administration (FDA) has approved marstacimab-hncq\u2014developed by Pfizer\u2014for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). A notable benefit of marstacimab-hncq is that it is delivered subcutaneously once weekly through a pre-filled pen or syringe. <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-treatment-hemophilia-or-b\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n\n<hr \/>\n\n<p class=\"clamp_p\"><strong>Fidanacogene elaparvovec gene therapy approved for Europe<br class=\"\">\nJuly 25, 2024<\/strong> \u2014 The European Commission has approved fidanacogene elaparvovec, an adeno-associated viral (AAV) vector-based gene therapy for the treatment of hemophilia B in Europe. Developed by Pfizer, the treatment is for adults (aged 18 years or older) with moderately severe to severe hemophilia B (congenital Factor IX deficiency) who are negative for neutralizing antibodies to variant AAV serotype Rh74. <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/new-gene-therapy-treatment-haemophilia-b\" target=\"_blank\" rel=\"noopener\">LINK<\/a>\n\n<hr \/>\n\n<p class=\"clamp_p\"><strong>NEJM publishes phase 3 data supporting the use of efanesoctocog alfa for treating children with severe hemophilia A<br class=\"\">\nJuly 18, 2024 <\/strong>\u2014 Full results from the XTEND-Kids phase 3 study published in The New England Journal of Medicine (NEJM) highlights the efficacy, safety, and pharmacokinetic profile of Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein. Efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy, is approved for adults and children with hemophilia A for routine prophylaxis and on-demand treatment to control bleeding episodes as well as for perioperative management (surgery). <a href=\"https:\/\/www.prnewswire.com\/news-releases\/nejm-publishes-altuvoct-phase-3-xtend-kids-results-highlighting-treatment-potential-for-children-with-severe-haemophilia-a-302200371.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n\n<hr \/>\n\n<p class=\"clamp_p\"><strong>U.S. FDA approves gene therapy for hemophilia B<br class=\"\">\nApril 26, 2024 <\/strong>\u2014 Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved fidanacogene elaparvovec-dzkt for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who:\n<ul class=\"clamp_p\">\n \t<li>Currently use factor IX prophylaxis therapy, or<\/li>\n \t<li>Have current or historical life-threatening hemorrhage, or<\/li>\n \t<li>Have repeated, serious spontaneous bleeding episodes, and,<\/li>\n \t<li>Do not have neutralizing antibodies to the adeno-associated virus serotype used<\/li>\n<\/ul>\n<a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/beqvez\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n\n<hr \/>\n<p class=\"clamp_p\"><strong>Fidanacogene elaparvovec gene therapy approved for the treatment of hemophilia B<\/strong><br class=\"\">\n<strong>January 3, 2024 <\/strong>\u2014 Health Canada has approved fidanacogene elaparvovec, an adeno-associated viral (AAV) vector-based gene therapy for the treatment of hemophilia B which has been developed by Pfizer. The treatment is for adults (aged 18 years or older) with moderately severe to severe hemophilia B (congenital Factor IX deficiency) who are negative for neutralizing antibodies to variant AAV serotype Rh74. <a href=\"https:\/\/www.newswire.ca\/news-releases\/health-canada-approves-pfizer-canada-s-gene-therapy-in-hemophilia-b-841249479.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n\n<hr \/>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/p>\r\n<\/div>\r\n\r\n<div id=\"pr2023\" class=\"tabcontent\">\r\n  <p>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"55222\" class=\"elementor elementor-55222\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5e9425d9 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"5e9425d9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-72fe8f48\" data-id=\"72fe8f48\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cf2f82a elementor-widget elementor-widget-text-editor\" data-id=\"cf2f82a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"clamp_p\"><strong>BioMarin Announces First Person Treated Commercially with valoctocogene roxaparvovec-rvox<\/strong><br \/><strong>August 30, 2023 \u2014<\/strong> BioMarin Pharmaceutical Inc. announced today that an individual in Germany with severe hemophilia A was treated with valoctocogene roxaparvovec-rvox, marking the first time that this gene therapy has been given commercially in Europe. <a href=\"https:\/\/can01.safelinks.protection.outlook.com\/?url=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fbiomarin-announces-first-person-treated-commercially-with-roctavian-valoctocogene-roxaparvovec-rvox-for-severe-hemophilia-a-in-europe-301914118.html&amp;data=05%7C01%7Cmsemienchuk%40wfh.org%7Cbcd2822e2dba48f0911308dbaa38124c%7Cac8b0aef17b84870998367a82a6bcc3f%7C0%7C0%7C638290930018208264%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=wFmNOBc7wYqQaEMaE2m7%2B5%2BP6IwjqRL3w1e3aVbb%2FNM%3D&amp;reserved=0\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Roche discontinues hemophilia A gene therapy treatment candidate<br \/>July 28, 2023 \u2014<\/strong> Roche is discontinuing the development of a mid-stage gene therapy candidate which was previously being assessed as a treatment for hemophilia A patients with inhibitors to factor VIII, the company announced Thursday. <a href=\"https:\/\/www.biospace.com\/article\/roche-drops-hemophilia-a-candidate-prepares-for-the-impacts-of-ira\/#:~:text=Roche%20is%20discontinuing%20the%20development,its%20second-quarter%20earnings%20report\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>U.S. Food and Drug Administration Approves BioMarin\u2019s valoctocogene roxaparvovec-rvox, the first gene therapy for adults with severe hemophilia A<\/strong><br \/><strong>June 29, 2023 \u2014<\/strong> BioMarin today announced that the United States Food and Drug Administration (FDA) approved valoctocogene roxaparvovec-rvox gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity &lt; 1 IU\/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The one-time, single-dose infusion is the first approved gene therapy for severe hemophilia A in the U.S. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/us-food-and-drug-administration-approves-biomarins-roctavian-valoctocogene-roxaparvovec-rvox-the-first-and-only-gene-therapy-for-adults-with-severe-hemophilia-a-301867403.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>CSL Behring Announces the first patient has received FDA-Approved etranacogene dezaparvovec-drlb for hemophilia B<br \/><\/strong><strong>June 20, 2023 \u2014 <\/strong>Etranacogene dezaparvovec-drlb (Hemgenix), the first FDA approved gene therapy for hemophilia B, has now been administered for the first time as an approved product to a person with hemophilia B. Hemgenix is also approved for use in the EU and has been granted conditional marketing authorization by the UK&rsquo;s Medicines and Healthcare product Regulatory Agency. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/csl-behring-announces-the-first-patient-has-received-fda-approved-hemgenix-etranacogene-dezaparvovec-drlb-for-hemophilia-b-301854676.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Two fitusiran Phase 3 studies published in The Lancet and The Lancet Haematology highlight potential to address unmet needs across all types of hemophilia.<\/strong><br \/><strong>April 4, 2023 \u2014<\/strong>\u00a0Both Phase 3 studies achieved their primary and secondary endpoints; fitusiran prophylaxis demonstrated significant and clinically meaningful improvements in bleed protection in people with hemophilia with and without inhibitors. <a href=\"https:\/\/www.sanofi.com\/en\/media-room\/press-releases\/2023\/2023-04-04-05-00-00-2640246\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>B<\/strong><strong>ioMarin provides update on FDA review of valoctocogene roxaparvovec gene therapy for adults with severe hemophilia A<br \/><\/strong><strong>March 6, 2023 \u2014<\/strong> BioMarin Pharmaceutical Inc. announced today that it received notice this afternoon from the U.S. Food and Drug Administration (FDA) that the agency has extended review of the company\u2019s Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for adults with severe hemophilia A. The FDA determined that the submission of the three-year data analysis from the ongoing Phase 3 GENEr8-1 study constituted a Major Amendment due to the substantial amount of additional data and set a new PDUFA Target Action Date of June 30, 2023. The company had previously communicated that this data submission could be qualified as a Major Amendment. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/biomarin-provides-update-on-fda-review-of-roctavian-valoctocogene-roxaparvovec-gene-therapy-for-adults-with-severe-hemophilia-a-301763924.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Completed XTEND-Kids Phase 3 Sanofi and Sobi study strengthens potential of Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl for treatment of children &lt;12 years of age with hemophilia A<br \/>March 2, 2023<\/strong> \u2014 The XTEND-Kids phase 3 Sanofi and Sobi study evaluating the safety, efficacy and pharmacokinetics of Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl as once-weekly prophylaxis in previously treated patients &lt;12 years of age with severe hemophilia A met its primary endpoint of safety, with no FVIII inhibitors detected in 74 children, with more than 50 children experiencing at least 50 exposure days, nearly a full year of treatment. The completion of XTEND-Kids represents the final milestone needed for regulatory submission in the EU. <a href=\"https:\/\/www.sanofi.com\/en\/media-room\/press-releases\/2023\/2023-03-02-07-00-00-2618928\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>FDA approves once-weekly Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl a new class of factor VIII therapy for hemophilia A<br \/>February 23, 2023<\/strong> \u2013 Sanofi announces that the U.S. Food and Drug Administration (FDA) has approved Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl, previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. This treatment is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. <a href=\"https:\/\/www.globenewswire.com\/news-release\/2023\/02\/23\/2614759\/0\/en\/Press-Release-FDA-approves-once-weekly-ALTUVIIIO-a-new-class-of-factor-VIII-therapy-for-hemophilia-A-that-offers-significant-bleed-protection.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>.<strong><br \/><\/strong><\/p><hr \/><p class=\"clamp_p\"><strong>NEJM publishes once-weekly efanesoctocog alfa Phase 3 data for people with hemophilia A<br \/>January 25, 2023<\/strong> \u2013 Pivotal study data published in The New England Journal of Medicine (NEJM) highlights the efficacy, safety, and pharmacokinetic profile of efanesoctocog alfa, an investigational treatment for hemophilia A. These data demonstrate that efanesoctocog alfa delivered normal to near-normal factor activity levels (&gt;40%) for the majority of the week with once-weekly dosing. <a href=\"https:\/\/www.sanofi.com\/en\/media-room\/press-releases\/2023\/2023-01-25-22-30-00-2595681\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>BioMarin Announces Stable and Durable Annualized Bleed Control at 3 years for ROCTAVIAN\u2122<br \/>January 8, 2023<\/strong> \u2014 BioMarin Pharmaceutical Inc. today announced positive results from three years of follow up from its ongoing global Phase 3 GENEr8-1 study of ROCTAVIANTM(valoctocogene roxaparvovec), an investigational one-time gene therapy for the treatment of adults with severe hemophilia A. This is the largest and longest global Phase 3 study to date for any gene therapy in hemophilia with 134 participants. <a href=\"https:\/\/investors.biomarin.com\/news\/news-details\/2023\/BioMarin-Announces-Stable-and-Durable-Annualized-Bleed-Control-for-ROCTAVIAN-in-Largest-Phase-3-Gene-Therapy-Study-in-Adults-with-Severe-Hemophilia-A-134-Participant-Study-Met-All-Primary-and-Secondary-Efficacy-Endpoints-at-3-Yea-01-08-2023\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/p>\r\n<\/div>\r\n\r\n<div id=\"pr2022\" class=\"tabcontent\">\r\n  <p>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"50728\" class=\"elementor elementor-50728\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-783e6357 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"783e6357\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5e34af25\" data-id=\"5e34af25\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aaa588e elementor-widget elementor-widget-text-editor\" data-id=\"aaa588e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"clamp_p\"><strong>Pfizer Announces Positive Top-Line Results from Phase 3 Study of Hemophilia B Gene Therapy Candidate<\/strong><br \/><strong>December 29, 2022<\/strong> \u2014 Pfizer Inc. today announced positive top-line results from the Phase 3 BENEGENE-2 study evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. <a href=\"https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer-announces-positive-top-line-results-phase-3-study\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>EMA recommends granting a conditional marketing authorisation in EU for Hemgenix<br \/>December 16, 2022 \u2014<\/strong> The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation in the European Union (EU) for CSL Behring GmbH\u2019s Hemgenix (etranacogene dezaparvovec) for the treatment of severe and moderately severe haemophilia B in adults who do not have factor IX inhibitors (auto-antibodies produced by the immune system which make factor IX medicines less effective). Hemgenix is the first gene therapy to treat haemophilia B. It is delivered as a single infusion. <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-gene-therapy-treat-haemophilia-b\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>CHMP recommends expansion of EU label for emicizumab to include people with moderate hemophilia A<br \/>December 16, 2022 \u2014 <\/strong>Roche announced that the European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the emicizumab European Union (EU) marketing authorisation. If approved, the therapy would also be indicated for the routine prophylaxis of bleeding episodes in people with hemophilia A without factor VIII inhibitors who have moderate disease (FVIII \u22651% and \u2264 5%) with a severe bleeding phenotype. <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/smop\/chmp-post-authorisation-summary-opinion-hemlibra-ii-27_en.pdf\" target=\"_blank\" rel=\"noopener\">LINK<\/a>.<\/p><hr \/><p class=\"clamp_p\"><strong>U.S. Food and Drug Administration approves CSL\u2019s HEMGENIX<sup>\u00ae<\/sup> (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B<\/strong><br class=\"\" \/><strong>November 22, 2022 \u2014 <\/strong>CSL today announced that the U.S. Food and Drug Administration (FDA) approved HEMGENIX<sup>\u00ae<\/sup> (etranacogene dezaparvovec-drlb), the first one-time gene therapy for appropriate adults with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes. <a href=\"https:\/\/www.cslbehring.com\/newsroom\/2022\/fda-hemgenix\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Freeline takes difficult decision to not progress their hemophilia B program into Phase 3 development<\/strong><br class=\"\" \/><strong>November 15, 2022 \u2014 <\/strong>As a result of a previously announced evaluation of its investigational gene therapy program for hemophilia B, Freeline has decided to focus its resources on other programs, and stop investment in further development of it\u2019s hemophilia B program without a partner. <a href=\"https:\/\/freeline.life\/freeline-reports-third-quarter-2022-financial-results-and-corporate-update\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>First Gene Therapy for Adults with Severe Hemophilia A, BioMarin&rsquo;s ROCTAVIAN (valoctocogene roxaparvovec), Approved by European Commission (EC) <\/strong><strong>SAN RAFAEL, Calif.<br \/>Aug. 24, 2022 \u2014 <\/strong>BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). <a href=\"https:\/\/investors.biomarin.com\/news\/news-details\/2022\/First-Gene-Therapy-for-Adults-with-Severe-Hemophilia-A-BioMarins-ROCTAVIAN-valoctocogene-roxaparvovec-Approved-by-European-Commission-EC-08-24-2022\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Monkeypox Virus and Plasma Protein Therapies<\/strong><br class=\"\" \/><strong>27 June 2022 \u2014 <\/strong>PPTA considers that the current MPXV outbreak is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies. This assessment is also shared by other concerned parties (AABB, WHO). <a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/06\/PPTA-GPSC22033a-MPX-virus-position-statement-Jun2022.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Precision BioLogic Launches New Product to Improve Testing for Hemophilia B<\/strong><br class=\"\" \/><strong>MONTREAL \u2013 May 9, 2022 \/CNW\/ \u2014 <\/strong><a href=\"https:\/\/precisionbiologic.com\/\" target=\"_blank\" rel=\"noopener\">Precision BioLogic Inc.<\/a>, a leading developer of hemostasis diagnostic products, is pleased to announce the launch of its new <a href=\"https:\/\/precisionbiologic.com\/products\/diagnostic-kits\/cryocheck-chromogenic-factor-ix\" target=\"_blank\" rel=\"noopener\">CRYOcheck Chromogenic Factor IX<\/a> assay in Canada, the European Union, Australia, and New Zealand following market authorization by Health Canada and respective in-country regulatory authorities. The announcement was made at the World Federation of Hemophilia Congress taking place in Montreal, May 8\u201311, 2022. <a href=\"https:\/\/www.newswire.ca\/news-releases\/precision-biologic-launches-new-product-to-improve-testing-for-hemophilia-b-865413615.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B<\/strong><br class=\"\" \/><strong>MARBURG, GERMANY \u2013 March 28, 2022 \u2014 <\/strong>Global biotherapeutics leader <a href=\"http:\/\/www.cslbehring.com\/\" target=\"_blank\" rel=\"noopener\">CSL Behring<\/a> today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etranacogene dezaparvovec (EtranaDez) under its accelerated assessment procedure. <a href=\"https:\/\/www.cslbehring.com\/newsroom\/2022\/ema-commences-review-of-novel-gene-therapy-candidate-etranadez-for-people-with-hemophilia-b\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>BioMarin Announces Publication in New England Journal of Medicine of One-Year Results from Phase 3 Pivotal Trial with Valoctocogene Roxaparvovec Gene Therapy in Adults with Severe Hemophilia A<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 Mar. 17, 2022 \/PRNewswire\/, Ozelo, M. et al., Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A. N Engl J Med 2022; 386:1013-1025, DOI: 10.1056\/NEJMoa2113708 \u2014 <\/strong>BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced publication of results from the Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A, in the <em>New England Journal of Medicine<\/em> (NEJM). <a href=\"https:\/\/www.prnewswire.com\/news-releases\/biomarin-announces-publication-in-new-england-journal-of-medicine-of-one-year-results-from-phase-3-pivotal-trial-with-valoctocogene-roxaparvovec-gene-therapy-in-adults-with-severe-hemophilia-a-301504817.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>Biomarin gives an update and reports a serious adverse event for its Phase 3 hemophilia A gene therapy study<\/strong><br class=\"\" \/><strong>Feb. 4, 2022 \u2014 <\/strong>An update for the hemophilia community from BioMarin, regarding the ongoing Phase 3 BioMarin hemophilia A gene therapy study, and a serious adverse event deemed, by the Independent Data Safety Monitoring Committee, unrelated to the investigational gene therapy from the phase 1\/2 study. <a href=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/02\/BioMarin-Hemophilia-NORAM-Program-Update-for-Patient-Associations-Feb2022.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p><hr \/><p class=\"clamp_p\"><strong>BioMarin Announces Stable and Durable Annualized Bleed Control in the Largest Phase 3 Gene Therapy Study in Adults with Severe Hemophilia A<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 Jan. 9, 2022 \u2014 <\/strong>BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced positive results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. This is the largest global Phase 3 study to date for any gene therapy in hemophilia, with 134 participants.\u00a0<a href=\"https:\/\/www.prnewswire.com\/news-releases\/biomarin-announces-stable-and-durable-annualized-bleed-control-in-the-largest-phase-3-gene-therapy-study-in-adults-with-severe-hemophilia-a-134-participant-study-met-all-primary-and-secondary-efficacy-endpoints-at-two-year-analys-301456772.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/p>\r\n<\/div>\r\n\r\n<div id=\"pr2021\" class=\"tabcontent\">\r\n  <p class=\"clamp_p\"><strong>Sigilon Therapeutics Announces Strategic Reprioritization\r\n<\/strong><br class=\"\" \/><strong>CAMBRIDGE, Mass. \u2013 Dec. 13, 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>Sigilon Therapeutics, Inc. (NASDAQ: SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform, today announced a strategic reprioritization to enable the Company to focus on MPS-1 and diabetes.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/Sigilon-Therapeutics-Announces-Strategic-Reprioritization-Dec2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Sigilon Therapeutics Announces Update on SIG-001 Phase 1\/2 Study in Hemophilia A<\/strong><br class=\"\" \/><strong>CAMBRIDGE, Mass. \u2013 Nov. 29, 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>Sigilon Therapeutics, Inc. (NASDAQ:SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform, today reported that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1\/2 study of SIG-001 in severe or moderately severe hemophilia A.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/Sigilon-Therapeutics-Announces-Update-on-SIG-001-Phase-1-2-Study-in-Hemophilia-A-Nov2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>FDA places the Pfizer\/Sangamo Therapeutics phase 3 AFFINE haemophilia A gene therapy study on clinical hold<\/strong><br class=\"\" \/><strong>5 novembre 2021 \u2014<\/strong> On Tuesday, November 4, the U.S. Food and Drug Administration (FDA) placed the Pfizer\/Sangamo haemophilia A gene therapy programme, including the pivotal phase 3 AFFINE study ( <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04370054\" target=\"_blank\" rel=\"noopener\">NCT04370054<\/a> ), with giroctocogene fitelparvovec (SB-525 or PF-07055480), on clinical hold until the review of a proposed protocol amendment. ( <a href=\"https:\/\/investor.sangamo.com\/news-releases\/news-release-details\/sangamo-therapeutics-reports-recent-business-and-clinical\" target=\"_blank\" rel=\"noopener\">Sangamo news release<\/a> ). <a href=\"https:\/\/news.wfh.org\/wp-content\/uploads\/FDA-places-AFFINE-haemophilia-on-clinical-hold-1.pdf\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Spark Therapeutics\u2019 SPK-8011 Suggests Stable and Durable Factor VIII Expression in Largest Phase 1\/2 Gene Therapy Study in Hemophilia A to Date\r\n<\/strong><br class=\"\" \/><strong>PHILADELPHIA \u2013 21 juillet 2021 \u2014<\/strong> Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced updated data from the ongoing Phase 1\/2 clinical trial of investigational SPK-8011 in hemophilia A during the International Society of Thrombosis and Hemostasis (ISTH) 2021 Virtual Congress (July 17-21). <a href=\"https:\/\/sparktx.com\/press_releases\/spark-therapeutics-spk-8011-suggests-stable-and-durable-factor-viii-expression-in-largest-phase-1-2-gene-therapy-study-in-hemophilia-a-to-date\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>European Medicines Agency Validates BioMarin's Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A\r\n<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 15 juillet 2021 (PRNewswire) \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. With today's validation the MAA review can now commence. A CHMP opinion is anticipated in the first half of 2022. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/european-medicines-agency-validates-biomarins-marketing-authorization-application-for-valoctocogene-roxaparvovec-to-treat-severe-hemophilia-a-301334635.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update\r\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 22 juin 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced positive 52-week clinical data on all patients from its pivotal, Phase III HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe and moderately severe hemophilia B. These are the first clinical data to be reported from a Phase III gene therapy study in hemophilia B and, with 54 patients, the largest set of hemophilia B patients receiving a single gene therapy investigational product to date.\u00a0<a href=\"https:\/\/www.globenewswire.com\/en\/news-release\/2021\/06\/22\/2251227\/0\/en\/uniQure-Announces-Positive-52-Week-Clinical-Data-from-HOPE-B-Pivotal-Trial-of-Etranacogene-Dezaparvovec-Gene-Therapy-in-Patients-with-Hemophilia-B-and-Provides-Regulatory-Update.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>European Medicines Agency Grants BioMarin's Request for Accelerated Assessment of Valoctocogene Roxaparvovec for Treatment of Severe Hemophilia A\r\n<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 24 mai 2021 (PRNewswire) \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) has granted its request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe hemophilia A. Accelerated assessment reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). A CHMP opinion is expected in the first half of 2022. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/european-medicines-agency-grants-biomarins-request-for-accelerated-assessment-of-valoctocogene-roxaparvovec-for-treatment-of-severe-hemophilia-a-301297531.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure\r\n<\/strong><br class=\"\" \/><strong>KING OF PRUSSIA, PA, USA \u2013 6 mai 2021 \u2014<\/strong> Global biotherapeutics leader CSL Behring today announced the closing of its global Commercialization and License agreement with uniQure (NASDAQ: QURE) for etranacogene dezaparvovec (AMT-061), a novel gene therapy for the treatment of hemophilia B. CSL Behring has been recognized as a global hematology leader for decades. The acquisition complements both CSL Behring\u2019s cell and gene therapy scientific platform and its hematology product portfolio, which include other treatments for hemophilia B as well as therapies for treating hemophilia A, von Willebrand disease, thrombosis, and other life-threatening conditions. <a href=\"https:\/\/www.cslbehring.com\/newsroom\/2021\/cslbehring-to-commercialize-amt-061\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>uniQure announces closing of commercialization and license agreement with CSL Behring\r\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 6 mai 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for the global licensing agreement with CSL Behring for etranacogene dezaparvovec, an investigational gene therapy for patients with hemophilia B, expired on 5 mai 2021, and the agreement became fully effective today, 6 mai 2021. The agreement was contingent on completion of review under antitrust laws in the United States, Australia, and the United Kingdom. The antitrust review process is now complete in all three countries.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/uniQure-announces-closing-of-commercialization-and-license-agreement-with-CSL-Behring-May2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program\r\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 26 avril 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Company\u2019s hemophilia B gene therapy program after determining the Company satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/uniQure-Announces-FDA-Removes-Clinical-Hold-on-Hemophilia-B-Gene-Therapy-Program-April2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>uniQure Announces Findings from Reported Case of Hepatocellular Carcinoma (HCC) in Hemophilia B Gene Therapy Program\r\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 29 mars 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today the results of a comprehensive investigation into the case of hepatocellular carcinoma (HCC) diagnosed in one patient in the HOPE-B pivotal trial of etranacogene dezaparvovec. The results of the investigation found that it is highly unlikely the HCC was caused by etranacogene dezaparvovec.\u00a0<a href=\"https:\/\/www.globenewswire.com\/news-release\/2021\/03\/29\/2200653\/0\/en\/uniQure-Announces-Findings-from-Reported-Case-of-Hepatocellular-Carcinoma-HCC-in-Hemophilia-B-Gene-Therapy-Program.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Takeda Announces Strategic Partnership to Accelerate the Development of Enzyre\u2019s Diagnostic Technology Platform That Aims to Improve the Standard of Care for Patients with Bleeding Disorders\r\n<\/strong><br class=\"\" \/><strong>OSAKA, JAPAN \u2013 4 mars 2021 \u2014 <\/strong>Takeda Pharmaceutical Company Limited (TSE:\u00a04502\/NYSE:TAK) (\u201cTakeda\u201d) today announced it has entered into a strategic partnership with Enzyre to accelerate the development of Enzyre\u2019s proprietary platform Enzypad to enable patients to test their blood coagulation in a home setting. The partnership builds on an existing research collaboration agreement with Enzyre signed in December 2019 and close collaboration over the last five years.\u00a0<a href=\"https:\/\/www.takeda.com\/newsroom\/statements\/2021\/takeda-announces-strategic-partnership-to-accelerate-the-development-of-enzyres-diagnostic-technology-platform-that-aims-to-improve-the-standard-of-care-for-patients-with-bleeding-disorders\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Data at EAHAD 2021 Highlight Value of Takeda\u2019s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements\r\n<\/strong><br class=\"\" \/><strong>OSAKA, JAPAN \u2013 3 f\u00e9vrier 2021 \u2014 <\/strong>Takeda Pharmaceutical Company Limited (TSE: 4502\/NYSE:TAK) (\u201cTakeda\u201d) today announced that 14 abstracts from the company\u2019s Hematology portfolio and pipeline are being presented as electronic posters at the Virtual European Association for Haemophilia and Allied Disorders Congress (EAHAD 2021). Data include multiple abstracts reinforcing the long-term efficacy and safety of Takeda\u2019s hematology portfolio in clinical practice, supporting the value of these treatments in a real world setting. <a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/Takeda-Data-at-EAHAD2021-February2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>BioMarin Announces Positive Phase 3 Gene Therapy Trial Results in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set<\/strong><br class=\"\" \/><strong>SAN RAFAEL, U.S.A. \u2013 10 janvier 2021 \u2014 <\/strong>BioMarin Pharmaceutical Inc. today announced positive topline results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/biomarin-announces-positive-phase-3-gene-therapy-trial-results-in-adults-with-severe-hemophilia-a-study-met-all-primary-and-secondary-efficacy-endpoints-in-one-year-data-set-301204797.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n<\/div>\r\n\r\n<div id=\"pr2020\" class=\"tabcontent\">\r\n  <p class=\"clamp_p\"><strong>UniQure Reports Development of Hepatocellular Carcinoma in a Gene Therapy Clinical Trial Participant\r\n<\/strong><br class=\"\" \/><strong>Lexington, MA and Amsterdam, the Netherlands \u2013 21 d\u00e9cembre 2020 (BUSINESS WIRE) \u2014 <\/strong>UniQure, which is running a Phase 3 AAV5-Factor IX gene therapy study, reported today a case of hepatocellular carcinoma (HCC) in a trial participant1. HCC is a tumor that arises in the liver. <a href=\"https:\/\/news.wfh.org\/wp-content\/uploads\/2020-12-21-uniQure-Press-Release.pdf\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Pfizer Doses First Participant in Phase 3 Study Evaluating anti-TFPI Investigational Therapy, Marstacimab, for People With Severe Hemophilia A and B With or Without Inhibitors<\/strong><br class=\"\" \/><strong>NEW YORK, U.S.A. \u2013 23 novembre 2020 (BUSINESS WIRE) \u2014 <\/strong>Pfizer Inc. (NYSE: PFE) today announced that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor (anti-TFPI) being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors. <a href=\"https:\/\/www.businesswire.com\/news\/home\/20201123005602\/en\/Pfizer-Doses-Participant-Phase-3-Study-Evaluating\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>uniQure Announces Positive Top-Line Data from the HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B<\/strong><br class=\"\" \/><strong>LEXINGTON, Ma. \u2013 19 novembre 2020 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced positive top-line data from its pivotal, Phase III HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe and moderately severe hemophilia B. This is the first data set to be reported from a Phase III gene therapy study in hemophilia B and, with 54 patients, the largest set of patients receiving a single gene therapy investigational product to be reported to date. These clinical data were published today as a late-breaking abstract, one of only six accepted for presentation at the 62nd Annual Meeting of the American Society of Hematology (ASH) and will be featured as an oral presentation in the conference on 8 d\u00e9cembre 2020.  <a href=\"https:\/\/www.globenewswire.com\/en\/news-release\/2020\/11\/19\/2130233\/0\/en\/uniQure-Announces-Positive-Top-Line-Data-from-the-HOPE-B-Pivotal-Trial-of-Etranacogene-Dezaparvovec-Gene-Therapy-in-Patients-with-Hemophilia-B.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a>.<\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Takeda to Present Rare Bleeding Disorders Research at Thrombosis & Hemostasis Summit of North America (THSNA) 2020<\/strong><br class=\"\" \/><strong>CAMBRIDGE, Ma. and OSAKA, JAPAN \u2013 27 octobre 2020 \u2014 <\/strong>Takeda Pharmaceutical Company Limited (TSE: 4502\/NYSE:TAK) (\u201cTakeda\u201d), today presented four abstracts at the Thrombosis and Hemostasis Summit of North America (THSNA), highlighting Takeda\u2019s commitment to advancing personalized care in people living with bleeding disorders. <a href=\"https:\/\/www.takeda.com\/en-us\/newsroom\/news-releases\/2020\/takeda-to-present-rare-bleeding-disorders-research-2020\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>rHEALTH\u2019s FVIII Point-of-Care Device Awarded $1.5M Direct-to-\r\nPhase II Grant from the NIH<\/strong><br class=\"\" \/><strong>BEDFORD, Ma. \u2013 8 octobre 2020 \u2014<\/strong>\r\nrHEALTH LLC, a <em>Diagnose Yourself, Anywhere<\/em>\u2122 company, today announced that its technology is the subject of the award from the National Institute of Health (NIH). The award is to rHEALTH\u2019s affiliate, the DNA Medicine Institute (DMI), which has granted rHEALTH commercial rights to the technology. The focus of the grant is to further develop the company\u2019s fingerstick-based point-of-care technology for monitoring both FVIII and emicizumab. <a href=\"http:\/\/www1.wfh.org\/docs\/website\/en\/news\/rHEALTH-FVIII-Point-of-Care-Devic-Direct-to-Phase-II-Grant-from-the-NIH-October2020.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>An update from Roche on the evolution of Hemlibra post-approval data communications<\/strong><br class=\"\" \/><strong>23 septembre 2020 \u2014<\/strong> At Roche we recognise and appreciate the interest that the haemophilia community has in regards to Hemlibra (emicizumab), specifically around the subject of its long-term efficacy and safety, both now and in the future. We understand that the subject of long-term safety for haemophilia treatments is an important topic also for the community, and at Roche we will continue to listen to the needs of the community and aspire to provide information that leads to better clinical decision making and patient care. <a href=\"http:\/\/www1.wfh.org\/docs\/website\/en\/news\/Roche-Emicizumab-Comms-Transition-Announcement-Letter-September2020.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>New England Journal of Medicine publishes positive final results from phase 1\/2a study of BIVV001 in people with severe haemophilia A<\/strong><br class=\"\" \/><strong>Stockholm & Paris \u2013 10 septembre 2020 \u2014<\/strong> <em><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2002699\" target=\"_blank\" rel=\"noopener\">The New England Journal of Medicine<\/a><\/em> today published positive final results from the phase 1\/2a trial evaluating the safety, tolerability and pharmacokinetics of BIVV001 (rFVIIIFc-VWF-XTEN) in adult patients with severe haemophilia A. BIVV001 is an investigational factor VIII therapy designed to provide higher bleed protection in a once-weekly prophylactic treatment regimen. Sobi (STO:SOBI) and Sanofi collaborate on the development and commercialization of BIVV001. <a href=\"https:\/\/www.sobi.com\/en\/press-releases\/new-england-journal-medicine-publishes-positive-final-results-phase-12a-study\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 19 ao\u00fbt 2020 \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A on 18 ao\u00fbt 2020. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/biomarin-receives-complete-response-letter-crl-from-fda-for-valoctocogene-roxaparvovec-gene-therapy-for-severe-hemophilia-a-301114587.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Precision BioLogic Inc. announces CRYOcheck\u2122 Chromogenic Factor VIII Assay Cleared for Sale in U.S<\/strong><br class=\"\" \/><strong>HALIFAX \u2013 20 juillet 2020 \u2014<\/strong> Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of its new CRYO<em>check<\/em> Chromogenic Factor VIII assay in the U.S. This clearance follows authorizations received from regulatory authorities in Canada, the European Union, Australia, and New Zealand where the assay launched earlier this year. <a href=\"http:\/\/www1.wfh.org\/docs\/website\/en\/news\/PrecisionBioLogic-CRYOcheck-Chromogenic-Factor-VIII-Cleared-for-Sale-in-US-July2020.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Takeda Provides Updates on Its Pharmacokinetic-guided Prophylaxis Studies at ISTH 2020, Reinforcing Its Commitment to Advancing Personalized Care for People with Bleeding Disorders<\/strong><br class=\"\" \/><strong>OSAKA, JAPAN \u2013 12 juillet 2020 \u2014<\/strong> Takeda Pharmaceutical Company Limited (\u201cTakeda\u201d) (TSE: 4502\/NYSE:TAK) today announced that 13 abstracts are being presented from the company\u2019s Hematology portfolio and pipeline at the International Society on Thrombosis and Haemostasis 2020 Virtual Congress (ISTH 2020). Among the data, Takeda spotlighted four abstracts to highlight its commitment to advancing personalized care through pharmacokinetic (PK)-guided prophylaxis in people living with hemophilia or von Willebrand Disease (VWD) \u2013 including scientific updates in patients with hemophilia A from the Phase 3 PROPEL and Phase 3b CONTINUATION studies investigating potential benefits of personalized TAK-660 (rurioctocog alfa pegol) prophylaxis. Two population studies into the PK\/pharmacodynamic (PD) profiles of recombinant von Willebrand factor (rVWF), which provide data to assist in the optimization of rVWF personalized dosing strategies, were also presented. <a href=\"https:\/\/www.takeda.com\/newsroom\/newsreleases\/2020\/takeda-provides-updates-on-its-pharmacokinetic-guided-prophylaxis-studies-at-isth-2020-reinforcing-its-commitment-to-advancing-personalized-care-for-people-with-bleeding-disorders\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>Spark Therapeutics Announces Updated Data on SPK-8011 from Phase 1\/2 Clinical Trial in Hemophilia A at ISTH 2020 Virtual Congress<\/strong><br class=\"\" \/><strong>PHILADELPHIA, Pa. \u2013 12 juillet 2020 \u2014<\/strong> Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced updated data from three dose cohorts of the ongoing Phase 1\/2 clinical trial of investigational SPK-8011 in hemophilia A. These data were presented at the International Society of Thrombosis and Hemostasis (ISTH) 2020 Virtual Congress by Principal Investigator Lindsey A. George, M.D., The Perelman School of Medicine, University of Pennsylvania and Children\u2019s Hospital of Philadelphia. <a href=\"https:\/\/sparktx.com\/press_releases\/isth2020\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>CSL Behring Agrees to Acquire Novel Late-Stage Gene Therapy Candidate for Hemophilia B Patients from uniQure\r\n<\/strong><br class=\"\" \/><strong>KING OF PRUSSIA, Pa. \u2013 24 juin 2020 \u2014<\/strong> Global biotherapeutics leader CSL Behring announced today that it has agreed to acquire exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy program, AMT-061 (etranacogene dezaparvovec), for the treatment of hemophilia B from uniQure (NASDAQ: QURE), a leading gene therapy company. The AMT-061 program, currently in Phase 3 clinical trials, could be one of the first gene therapies to provide potentially long-term benefits to patients with hemophilia B. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/csl-behring-agrees-to-acquire-novel-late-stage-gene-therapy-candidate-for-hemophilia-b-patients-from-uniqure-301083302.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\r\n\r\n\r\n<hr \/>\r\n<p class=\"clamp_p\"><strong>BioMarin Provides Highlights of 4 Years of Clinical Data from Ongoing Phase 1\/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 31 mai 2020 \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today an update to its previously reported results of an open-label Phase 1\/2 study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A. The data have been submitted as a late-breaking abstract to the World Federation of Hemophilia (WFH) Virtual Summit to be held June 14-19, 2020. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/biomarin-provides-highlights-of-4-years-of-clinical-data-from-ongoing-phase-12-study-of-valoctocogene-roxaparvovec-gene-therapy-for-severe-hemophilia-a-301068247.html\" target=\"blank\">LINK<\/a><\/p>\r\n<\/div>\r\n\r\n<script>\r\nfunction openPR(evt, year) {\r\n  var i, tabcontent, tablinks;\r\n  tabcontent = document.getElementsByClassName(\"tabcontent\");\r\n  for (i = 0; i < tabcontent.length; i++) {\r\n    tabcontent[i].style.display = \"none\";\r\n  }\r\n  tablinks = document.getElementsByClassName(\"tablinks\");\r\n  for (i = 0; i < tablinks.length; i++) {\r\n    tablinks[i].className = tablinks[i].className.replace(\" active\", \"\");\r\n  }\r\n  document.getElementById(year).style.display = \"block\";\r\n  evt.currentTarget.className += \" active\";\r\n}\r\n<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-209932a elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile elementor-tabs-view-horizontal elementor-widget elementor-widget-tabs\" data-id=\"209932a\" data-element_type=\"widget\" data-e-type=\"widget\" id=\"m-tabs\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-3411\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-3411\" aria-expanded=\"false\">2021<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-3412\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-3412\" aria-expanded=\"false\">2020<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-3411\" aria-expanded=\"false\">2021<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-3411\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-3411\" tabindex=\"0\" hidden=\"false\"><p class=\"clamp_p\"><strong>Sigilon Therapeutics Announces Strategic Reprioritization<br \/>\n<\/strong><br class=\"\" \/><strong>CAMBRIDGE, Mass. \u2013 Dec. 13, 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>Sigilon Therapeutics, Inc. (NASDAQ: SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform, today announced a strategic reprioritization to enable the Company to focus on MPS-1 and diabetes.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/Sigilon-Therapeutics-Announces-Strategic-Reprioritization-Dec2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Sigilon Therapeutics Announces Update on SIG-001 Phase 1\/2 Study in Hemophilia A<\/strong><br class=\"\" \/><strong>CAMBRIDGE, Mass. \u2013 Nov. 29, 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>Sigilon Therapeutics, Inc. (NASDAQ:SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform, today reported that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1\/2 study of SIG-001 in severe or moderately severe hemophilia A.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/Sigilon-Therapeutics-Announces-Update-on-SIG-001-Phase-1-2-Study-in-Hemophilia-A-Nov2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>FDA places the Pfizer\/Sangamo Therapeutics phase 3 AFFINE haemophilia A gene therapy study on clinical hold<\/strong><br class=\"\" \/><strong>5 novembre 2021 \u2014<\/strong> On Tuesday, November 4, the U.S. Food and Drug Administration (FDA) placed the Pfizer\/Sangamo haemophilia A gene therapy programme, including the pivotal phase 3 AFFINE study ( <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04370054\" target=\"_blank\" rel=\"noopener\">NCT04370054<\/a> ), with giroctocogene fitelparvovec (SB-525 or PF-07055480), on clinical hold until the review of a proposed protocol amendment. ( <a href=\"https:\/\/investor.sangamo.com\/news-releases\/news-release-details\/sangamo-therapeutics-reports-recent-business-and-clinical\" target=\"_blank\" rel=\"noopener\">Sangamo news release<\/a> ). <a href=\"https:\/\/news.wfh.org\/wp-content\/uploads\/FDA-places-AFFINE-haemophilia-on-clinical-hold-1.pdf\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Spark Therapeutics\u2019 SPK-8011 Suggests Stable and Durable Factor VIII Expression in Largest Phase 1\/2 Gene Therapy Study in Hemophilia A to Date<br \/>\n<\/strong><br class=\"\" \/><strong>PHILADELPHIA \u2013 21 juillet 2021 \u2014<\/strong> Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced updated data from the ongoing Phase 1\/2 clinical trial of investigational SPK-8011 in hemophilia A during the International Society of Thrombosis and Hemostasis (ISTH) 2021 Virtual Congress (July 17-21). <a href=\"https:\/\/sparktx.com\/press_releases\/spark-therapeutics-spk-8011-suggests-stable-and-durable-factor-viii-expression-in-largest-phase-1-2-gene-therapy-study-in-hemophilia-a-to-date\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>European Medicines Agency Validates BioMarin&rsquo;s Marketing Authorization Application for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A<br \/>\n<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 15 juillet 2021 (PRNewswire) \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) validated the Company&rsquo;s Marketing Authorization Application (MAA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. With today&rsquo;s validation the MAA review can now commence. A CHMP opinion is anticipated in the first half of 2022. <a href=\"https:\/\/investors.biomarin.com\/2021-07-15-European-Medicines-Agency-Validates-BioMarins-Marketing-Authorization-Application-for-Valoctocogene-Roxaparvovec-to-Treat-Severe-Hemophilia-A\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update<br \/>\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 22 juin 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced positive 52-week clinical data on all patients from its pivotal, Phase III HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe and moderately severe hemophilia B. These are the first clinical data to be reported from a Phase III gene therapy study in hemophilia B and, with 54 patients, the largest set of hemophilia B patients receiving a single gene therapy investigational product to date.\u00a0<a href=\"https:\/\/tools.eurolandir.com\/tools\/Pressreleases\/GetPressRelease\/?ID=3926165&amp;lang=en-GB&amp;companycode=nl-qure&amp;v=\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>European Medicines Agency Grants BioMarin&rsquo;s Request for Accelerated Assessment of Valoctocogene Roxaparvovec for Treatment of Severe Hemophilia A<br \/>\n<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 24 mai 2021 (PRNewswire) \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the European Medicines Agency (EMA) has granted its request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe hemophilia A. Accelerated assessment reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). A CHMP opinion is expected in the first half of 2022. <a href=\"https:\/\/investors.biomarin.com\/2021-05-24-European-Medicines-Agency-Grants-BioMarins-Request-for-Accelerated-Assessment-of-Valoctocogene-Roxaparvovec-for-Treatment-of-Severe-Hemophilia-A\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure<br \/>\n<\/strong><br class=\"\" \/><strong>KING OF PRUSSIA, PA, USA \u2013 6 mai 2021 \u2014<\/strong> Global biotherapeutics leader CSL Behring today announced the closing of its global Commercialization and License agreement with uniQure (NASDAQ: QURE) for etranacogene dezaparvovec (AMT-061), a novel gene therapy for the treatment of hemophilia B. CSL Behring has been recognized as a global hematology leader for decades. The acquisition complements both CSL Behring\u2019s cell and gene therapy scientific platform and its hematology product portfolio, which include other treatments for hemophilia B as well as therapies for treating hemophilia A, von Willebrand disease, thrombosis, and other life-threatening conditions. <a href=\"https:\/\/www.cslbehring.com\/newsroom\/2021\/cslbehring-to-commercialize-amt-061\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>uniQure announces closing of commercialization and license agreement with CSL Behring<br \/>\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 6 mai 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for the global licensing agreement with CSL Behring for etranacogene dezaparvovec, an investigational gene therapy for patients with hemophilia B, expired on 5 mai 2021, and the agreement became fully effective today, 6 mai 2021. The agreement was contingent on completion of review under antitrust laws in the United States, Australia, and the United Kingdom. The antitrust review process is now complete in all three countries.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/uniQure-announces-closing-of-commercialization-and-license-agreement-with-CSL-Behring-May2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program<br \/>\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 26 avril 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Company\u2019s hemophilia B gene therapy program after determining the Company satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial.\u00a0<a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/uniQure-Announces-FDA-Removes-Clinical-Hold-on-Hemophilia-B-Gene-Therapy-Program-April2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>uniQure Announces Findings from Reported Case of Hepatocellular Carcinoma (HCC) in Hemophilia B Gene Therapy Program<br \/>\n<\/strong><br class=\"\" \/><strong>LEXINGTON, Mass. and AMSTERDAM, The Netherlands \u2013 29 mars 2021 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today the results of a comprehensive investigation into the case of hepatocellular carcinoma (HCC) diagnosed in one patient in the HOPE-B pivotal trial of etranacogene dezaparvovec. The results of the investigation found that it is highly unlikely the HCC was caused by etranacogene dezaparvovec.\u00a0<a href=\"https:\/\/tools.eurolandir.com\/tools\/Pressreleases\/GetPressRelease\/?ID=3890956&amp;lang=en-GB&amp;companycode=nl-qure&amp;v=ticker\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Takeda Announces Strategic Partnership to Accelerate the Development of Enzyre\u2019s Diagnostic Technology Platform That Aims to Improve the Standard of Care for Patients with Bleeding Disorders<br \/>\n<\/strong><br class=\"\" \/><strong>OSAKA, JAPAN \u2013 4 mars 2021 \u2014 <\/strong>Takeda Pharmaceutical Company Limited (TSE:\u00a04502\/NYSE:TAK) (\u201cTakeda\u201d) today announced it has entered into a strategic partnership with Enzyre to accelerate the development of Enzyre\u2019s proprietary platform Enzypad to enable patients to test their blood coagulation in a home setting. The partnership builds on an existing research collaboration agreement with Enzyre signed in December 2019 and close collaboration over the last five years.\u00a0<a href=\"https:\/\/www.takeda.com\/newsroom\/statements\/2021\/takeda-announces-strategic-partnership-to-accelerate-the-development-of-enzyres-diagnostic-technology-platform-that-aims-to-improve-the-standard-of-care-for-patients-with-bleeding-disorders\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Data at EAHAD 2021 Highlight Value of Takeda\u2019s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements<br \/>\n<\/strong><br class=\"\" \/><strong>OSAKA, JAPAN \u2013 3 f\u00e9vrier 2021 \u2014 <\/strong>Takeda Pharmaceutical Company Limited (TSE: 4502\/NYSE:TAK) (\u201cTakeda\u201d) today announced that 14 abstracts from the company\u2019s Hematology portfolio and pipeline are being presented as electronic posters at the Virtual European Association for Haemophilia and Allied Disorders Congress (EAHAD 2021). Data include multiple abstracts reinforcing the long-term efficacy and safety of Takeda\u2019s hematology portfolio in clinical practice, supporting the value of these treatments in a real world setting. <a href=\"https:\/\/www1.wfh.org\/docs\/website\/en\/news\/Takeda-Data-at-EAHAD2021-February2021.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>BioMarin Announces Positive Phase 3 Gene Therapy Trial Results in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set<\/strong><br class=\"\" \/><strong>SAN RAFAEL, U.S.A. \u2013 10 janvier 2021 \u2014 <\/strong>BioMarin Pharmaceutical Inc. today announced positive topline results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. <a href=\"https:\/\/investors.biomarin.com\/2021-01-10-BioMarin-Announces-Positive-Phase-3-Gene-Therapy-Trial-Results-in-Adults-with-Severe-Hemophilia-A-Study-Met-All-Primary-and-Secondary-Efficacy-Endpoints-in-One-Year-Data-Set\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-3412\" aria-expanded=\"false\">2020<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-3412\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-3412\" tabindex=\"0\" hidden=\"hidden\"><p class=\"clamp_p\"><strong>UniQure Reports Development of Hepatocellular Carcinoma in a Gene Therapy Clinical Trial Participant<br \/>\n<\/strong><br class=\"\" \/><strong>Lexington, MA and Amsterdam, the Netherlands \u2013 21 d\u00e9cembre 2020 (BUSINESS WIRE) \u2014 <\/strong>UniQure, which is running a Phase 3 AAV5-Factor IX gene therapy study, reported today a case of hepatocellular carcinoma (HCC) in a trial participant1. HCC is a tumor that arises in the liver. <a href=\"https:\/\/news.wfh.org\/wp-content\/uploads\/2020-12-21-uniQure-Press-Release.pdf\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Pfizer Doses First Participant in Phase 3 Study Evaluating anti-TFPI Investigational Therapy, Marstacimab, for People With Severe Hemophilia A and B With or Without Inhibitors<\/strong><br class=\"\" \/><strong>NEW YORK, U.S.A. \u2013 23 novembre 2020 (BUSINESS WIRE) \u2014 <\/strong>Pfizer Inc. (NYSE: PFE) today announced that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor (anti-TFPI) being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors. <a href=\"https:\/\/www.businesswire.com\/news\/home\/20201123005602\/en\/Pfizer-Doses-Participant-Phase-3-Study-Evaluating\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>uniQure Announces Positive Top-Line Data from the HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B<\/strong><br class=\"\" \/><strong>LEXINGTON, Ma. \u2013 19 novembre 2020 (GLOBE NEWSWIRE) \u2014 <\/strong>uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced positive top-line data from its pivotal, Phase III HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe and moderately severe hemophilia B. This is the first data set to be reported from a Phase III gene therapy study in hemophilia B and, with 54 patients, the largest set of patients receiving a single gene therapy investigational product to be reported to date. These clinical data were published today as a late-breaking abstract, one of only six accepted for presentation at the 62nd Annual Meeting of the American Society of Hematology (ASH) and will be featured as an oral presentation in the conference on 8 d\u00e9cembre 2020. The abstract is available <a href=\"http:\/\/www.uniqure.com\/investors-newsroom\/ASH%202020_HOPE%20Ph%203%20LATE%20BREAKER_SUBMITTED_Colored%20title.pdf\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Takeda to Present Rare Bleeding Disorders Research at Thrombosis &amp; Hemostasis Summit of North America (THSNA) 2020<\/strong><br class=\"\" \/><strong>CAMBRIDGE, Ma. and OSAKA, JAPAN \u2013 27 octobre 2020 \u2014 <\/strong>Takeda Pharmaceutical Company Limited (TSE: 4502\/NYSE:TAK) (\u201cTakeda\u201d), today presented four abstracts at the Thrombosis and Hemostasis Summit of North America (THSNA), highlighting Takeda\u2019s commitment to advancing personalized care in people living with bleeding disorders. <a href=\"https:\/\/www.takeda.com\/en-us\/newsroom\/news-releases\/2020\/takeda-to-present-rare-bleeding-disorders-research-2020\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>rHEALTH\u2019s FVIII Point-of-Care Device Awarded $1.5M Direct-to-<br \/>\nPhase II Grant from the NIH<\/strong><br class=\"\" \/><strong>BEDFORD, Ma. \u2013 8 octobre 2020 \u2014<\/strong><br \/>\nrHEALTH LLC, a <em>Diagnose Yourself, Anywhere<\/em>\u2122 company, today announced that its technology is the subject of the award from the National Institute of Health (NIH). The award is to rHEALTH\u2019s affiliate, the DNA Medicine Institute (DMI), which has granted rHEALTH commercial rights to the technology. The focus of the grant is to further develop the company\u2019s fingerstick-based point-of-care technology for monitoring both FVIII and emicizumab. <a href=\"http:\/\/www1.wfh.org\/docs\/website\/en\/news\/rHEALTH-FVIII-Point-of-Care-Devic-Direct-to-Phase-II-Grant-from-the-NIH-October2020.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>An update from Roche on the evolution of Hemlibra post-approval data communications<\/strong><br class=\"\" \/><strong>23 septembre 2020 \u2014<\/strong> At Roche we recognise and appreciate the interest that the haemophilia community has in regards to Hemlibra (emicizumab), specifically around the subject of its long-term efficacy and safety, both now and in the future. We understand that the subject of long-term safety for haemophilia treatments is an important topic also for the community, and at Roche we will continue to listen to the needs of the community and aspire to provide information that leads to better clinical decision making and patient care. <a href=\"http:\/\/www1.wfh.org\/docs\/website\/en\/news\/Roche-Emicizumab-Comms-Transition-Announcement-Letter-September2020.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>New England Journal of Medicine publishes positive final results from phase 1\/2a study of BIVV001 in people with severe haemophilia A<\/strong><br class=\"\" \/><strong>Stockholm &amp; Paris \u2013 10 septembre 2020 \u2014<\/strong> <em><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2002699\" target=\"_blank\" rel=\"noopener\">The New England Journal of Medicine<\/a><\/em> today published positive final results from the phase 1\/2a trial evaluating the safety, tolerability and pharmacokinetics of BIVV001 (rFVIIIFc-VWF-XTEN) in adult patients with severe haemophilia A. BIVV001 is an investigational factor VIII therapy designed to provide higher bleed protection in a once-weekly prophylactic treatment regimen. Sobi (STO:SOBI) and Sanofi collaborate on the development and commercialization of BIVV001. <a href=\"https:\/\/www.sobi.com\/en\/press-releases\/new-england-journal-medicine-publishes-positive-final-results-phase-12a-study\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 19 ao\u00fbt 2020 \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company&rsquo;s Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A on 18 ao\u00fbt 2020. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. <a href=\"https:\/\/investors.biomarin.com\/2020-08-19-BioMarin-Receives-Complete-Response-Letter-CRL-from-FDA-for-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Severe-Hemophilia-A\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Precision BioLogic Inc. announces CRYOcheck\u2122 Chromogenic Factor VIII Assay Cleared for Sale in U.S<\/strong><br class=\"\" \/><strong>HALIFAX \u2013 20 juillet 2020 \u2014<\/strong> Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of its new CRYO<em>check<\/em> Chromogenic Factor VIII assay in the U.S. This clearance follows authorizations received from regulatory authorities in Canada, the European Union, Australia, and New Zealand where the assay launched earlier this year. <a href=\"http:\/\/www1.wfh.org\/docs\/website\/en\/news\/PrecisionBioLogic-CRYOcheck-Chromogenic-Factor-VIII-Cleared-for-Sale-in-US-July2020.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Takeda Provides Updates on Its Pharmacokinetic-guided Prophylaxis Studies at ISTH 2020, Reinforcing Its Commitment to Advancing Personalized Care for People with Bleeding Disorders<\/strong><br class=\"\" \/><strong>OSAKA, JAPAN \u2013 12 juillet 2020 \u2014<\/strong> Takeda Pharmaceutical Company Limited (\u201cTakeda\u201d) (TSE: 4502\/NYSE:TAK) today announced that 13 abstracts are being presented from the company\u2019s Hematology portfolio and pipeline at the International Society on Thrombosis and Haemostasis 2020 Virtual Congress (ISTH 2020). Among the data, Takeda spotlighted four abstracts to highlight its commitment to advancing personalized care through pharmacokinetic (PK)-guided prophylaxis in people living with hemophilia or von Willebrand Disease (VWD) \u2013 including scientific updates in patients with hemophilia A from the Phase 3 PROPEL and Phase 3b CONTINUATION studies investigating potential benefits of personalized TAK-660 (rurioctocog alfa pegol) prophylaxis. Two population studies into the PK\/pharmacodynamic (PD) profiles of recombinant von Willebrand factor (rVWF), which provide data to assist in the optimization of rVWF personalized dosing strategies, were also presented. <a href=\"https:\/\/www.takeda.com\/newsroom\/newsreleases\/2020\/takeda-provides-updates-on-its-pharmacokinetic-guided-prophylaxis-studies-at-isth-2020-reinforcing-its-commitment-to-advancing-personalized-care-for-people-with-bleeding-disorders\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>Spark Therapeutics Announces Updated Data on SPK-8011 from Phase 1\/2 Clinical Trial in Hemophilia A at ISTH 2020 Virtual Congress<\/strong><br class=\"\" \/><strong>PHILADELPHIA, Pa. \u2013 12 juillet 2020 \u2014<\/strong> Spark Therapeutics, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced updated data from three dose cohorts of the ongoing Phase 1\/2 clinical trial of investigational SPK-8011 in hemophilia A. These data were presented at the International Society of Thrombosis and Hemostasis (ISTH) 2020 Virtual Congress by Principal Investigator Lindsey A. George, M.D., The Perelman School of Medicine, University of Pennsylvania and Children\u2019s Hospital of Philadelphia. <a href=\"https:\/\/sparktx.com\/press_releases\/isth2020\/\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>CSL Behring Agrees to Acquire Novel Late-Stage Gene Therapy Candidate for Hemophilia B Patients from uniQure<br \/>\n<\/strong><br class=\"\" \/><strong>KING OF PRUSSIA, Pa. \u2013 24 juin 2020 \u2014<\/strong> Global biotherapeutics leader CSL Behring announced today that it has agreed to acquire exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy program, AMT-061 (etranacogene dezaparvovec), for the treatment of hemophilia B from uniQure (NASDAQ: QURE), a leading gene therapy company. The AMT-061 program, currently in Phase 3 clinical trials, could be one of the first gene therapies to provide potentially long-term benefits to patients with hemophilia B. <a href=\"https:\/\/www.prnewswire.com\/news-releases\/csl-behring-agrees-to-acquire-novel-late-stage-gene-therapy-candidate-for-hemophilia-b-patients-from-uniqure-301083302.html\" target=\"_blank\" rel=\"noopener\">LINK<\/a><\/p>\n<p><\/p>\n<hr \/>\n<p><\/p>\n<p class=\"clamp_p\"><strong>BioMarin Provides Highlights of 4 Years of Clinical Data from Ongoing Phase 1\/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A<\/strong><br class=\"\" \/><strong>SAN RAFAEL, Calif. \u2013 31 mai 2020 \u2014<\/strong> BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today an update to its previously reported results of an open-label Phase 1\/2 study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A. The data have been submitted as a late-breaking abstract to the World Federation of Hemophilia (WFH) Virtual Summit to be held June 14-19, 2020. <a href=\"https:\/\/investors.biomarin.com\/2020-05-31-BioMarin-Provides-Highlights-of-4-Years-of-Clinical-Data-from-Ongoing-Phase-1-2-Study-of-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Severe-Hemophilia-A\" target=\"blank\">LINK<\/a><\/p>\n<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f4b0a4b elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"f4b0a4b\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-39144a1\" data-id=\"39144a1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5439dd3 elementor-widget elementor-widget-template\" data-id=\"5439dd3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"page\" data-elementor-id=\"25647\" class=\"elementor elementor-25647 elementor-15864 elementor-15864\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0a1e965 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"0a1e965\" data-element_type=\"section\" data-e-type=\"section\" id=\"didyouknow\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a503e06\" data-id=\"a503e06\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1c884f6 elementor-section-full_width elementor-section-content-space-between elementor-section-height-default elementor-section-height-default\" data-id=\"1c884f6\" data-element_type=\"section\" data-e-type=\"section\" id=\"didyouknowsection\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-9fa7084 didyouknowcolumn\" data-id=\"9fa7084\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-97b2942 elementor-widget elementor-widget-heading\" data-id=\"97b2942\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Le saviez-vous\u202f?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45e8528 elementor-widget elementor-widget-toolset-view\" data-id=\"45e8528\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toolset-view.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n\n\n<div id=\"wpv-view-layout-16225\" class=\"js-wpv-view-layout js-wpv-layout-responsive js-wpv-view-layout-16225\" data-viewnumber=\"16225\" 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data-permalink=\"\/fr\/wp-json\/wp\/v2\/pages\/22821?wpv_view_count=16225\">\n\n\t\n\t\n\t\n\t\t<div class=\"tip-body\">\n\n<p>L&rsquo;initiative pour les pays les moins avanc\u00e9s de la FMH vise \u00e0 combler les lacunes dans l\u2019offre de soins des personnes atteintes de troubles de la coagulation en apportant un soutien, une expertise et une formation aux pays o\u00f9 le niveau de soins est minimal.<\/p>\n\n<\/div>\n<div class=\"tip-link\">\n  <a href=\"https:\/\/wfh.org\/fr\/identification-et-diagnostic\/\" target=\"new\" rel=\"noopener\">Tout savoir sur ce sujet<\/a>\n<\/div>\n\t\n\t\n\t\n\t\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-4afb142 didyouknowcolumn\" data-id=\"4afb142\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e65ed04 elementor-widget elementor-widget-heading\" data-id=\"e65ed04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">\u00c9v\u00e9nements \u00e0 venir<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d53508c elementor-widget elementor-widget-html\" data-id=\"d53508c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div\n\t class=\"tribe-common tribe-events tribe-events-view tribe-events-view--list tribe-events-view--shortcode tribe-events-view--shortcode-aa4c05e6\" 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tribe-common-a11y-hidden\"\n\tdata-js=\"tribe-events-view-link\"\n\taria-description=\"Cliquer pour s\u00e9lectionner la date du jour\"\n>\n\tAujourd\u2019hui<\/a>\n\n\t<div class=\"tribe-events-c-top-bar__datepicker\">\n\t<button\n\t\tclass=\"tribe-common-c-btn__clear tribe-common-h3 tribe-common-h--alt tribe-events-c-top-bar__datepicker-button\"\n\t\tdata-js=\"tribe-events-top-bar-datepicker-button\"\n\t\ttype=\"button\"\n\t\taria-description=\"Cliquer pour basculer le s\u00e9lectionneur de dates\"\n\t>\n\t\t<time\n\t\t\tdatetime=\"2026-04-08\"\n\t\t\tclass=\"tribe-events-c-top-bar__datepicker-time\"\n\t\t>\n\t\t\t\t\t\t\t<span class=\"tribe-events-c-top-bar__datepicker-mobile\">\n\t\t\t\t\t\u00c0 venir\t\t\t\t<\/span>\n\t\t\t\t<span class=\"tribe-events-c-top-bar__datepicker-desktop tribe-common-a11y-hidden\">\n\t\t\t\t\t\u00c0 venir\t\t\t\t<\/span>\n\t\t\t\t\t<\/time>\n\t\t\t\t<svg\n\t class=\"tribe-common-c-svgicon tribe-common-c-svgicon--caret-down tribe-events-c-top-bar__datepicker-button-icon-svg\" \taria-hidden=\"true\"\n\tviewBox=\"0 0 10 7\"\n\txmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n>\n\t<path fill-rule=\"evenodd\" clip-rule=\"evenodd\" d=\"M1.008.609L5 4.6 8.992.61l.958.958L5 6.517.05 1.566l.958-.958z\" class=\"tribe-common-c-svgicon__svg-fill\"\/>\n<\/svg>\n\t<\/button>\n\t<label\n\t\tclass=\"tribe-events-c-top-bar__datepicker-label tribe-common-a11y-visual-hide\"\n\t\tfor=\"tribe-events-top-bar-date\"\n\t>\n\t\tS\u00e9lectionnez une date.\t<\/label>\n\t<input\n\t\ttype=\"text\"\n\t\tclass=\"tribe-events-c-top-bar__datepicker-input tribe-common-a11y-visual-hide\"\n\t\tdata-js=\"tribe-events-top-bar-date\"\n\t\tid=\"tribe-events-top-bar-date\"\n\t\tname=\"tribe-events-views[tribe-bar-date]\"\n\t\tvalue=\"4\/8\/2026\"\n\t\ttabindex=\"-1\"\n\t\tautocomplete=\"off\"\n\t\treadonly=\"readonly\"\n\t\/>\n\t<div class=\"tribe-events-c-top-bar__datepicker-container\" data-js=\"tribe-events-top-bar-datepicker-container\"><\/div>\n\t<template class=\"tribe-events-c-top-bar__datepicker-template-prev-icon\">\n\t\t<svg\n\t class=\"tribe-common-c-svgicon tribe-common-c-svgicon--caret-left tribe-events-c-top-bar__datepicker-nav-icon-svg\" \taria-hidden=\"true\"\n\tviewBox=\"0 0 10 16\"\n\txmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n>\n\t<path d=\"M9.7 14.4l-1.5 1.5L.3 8 8.2.1l1.5 1.5L3.3 8l6.4 6.4z\"\/>\n<\/svg>\n\t<\/template>\n\t<template class=\"tribe-events-c-top-bar__datepicker-template-next-icon\">\n\t\t<svg\n\t class=\"tribe-common-c-svgicon tribe-common-c-svgicon--caret-right tribe-events-c-top-bar__datepicker-nav-icon-svg\" \taria-hidden=\"true\"\n\tviewBox=\"0 0 10 16\"\n\txmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n>\n\t<path d=\"M.3 1.6L1.8.1 9.7 8l-7.9 7.9-1.5-1.5L6.7 8 .3 1.6z\"\/>\n<\/svg>\n\t<\/template>\n<\/div>\n\n\t\n\t<div class=\"tribe-events-c-top-bar__actions tribe-common-a11y-hidden\">\n\t<\/div>\n\n<\/div>\n<\/header>\n\n\t\t\n\t\t<ul\n\t\t\tclass=\"tribe-events-calendar-list\"\n\t\t\taria-label=\"\n\t\t\tList of \u00c9v\u00e8nements\t\t\t\"\n\t\t>\n\n\t\t\t\t\t\t\t\n\t\t\t\t<li class=\"tribe-events-calendar-list__month-separator\">\n\t<h3>\n\t\t<time\n\t\t\tclass=\"tribe-events-calendar-list__month-separator-text tribe-common-h7 tribe-common-h6--min-medium tribe-common-h--alt\"\n\t\t>\n\t\t\tavril 2026\t\t<\/time>\n\t<\/h3>\n<\/li>\n\n\t\t\t\t<li  class=\"tribe-common-g-row tribe-events-calendar-list__event-row\" >\n\n\t<div  class=\"tribe-events-calendar-list__event-date-tag tribe-common-g-col post-159163 tribe_events type-tribe_events status-publish has-post-thumbnail hentry\"  >\n\t<time class=\"tribe-events-calendar-list__event-date-tag-datetime\" datetime=\"2026-04-17\" aria-hidden=\"true\">\n\t\t<span class=\"tribe-events-calendar-list__event-date-tag-weekday\">\n\t\t\tven\t\t<\/span>\n\t\t<span class=\"tribe-events-calendar-list__event-date-tag-daynum tribe-common-h5 tribe-common-h4--min-medium\">\n\t\t\t17\t\t<\/span>\n\t<\/time>\n<\/div>\n\n\t<div class=\"tribe-events-calendar-list__event-wrapper tribe-common-g-col\">\n\t\t<article  class=\"tribe-events-calendar-list__event tribe-common-g-row tribe-common-g-row--gutters post-159163 tribe_events type-tribe_events status-publish has-post-thumbnail hentry\" >\n\t\t\t<div class=\"tribe-events-calendar-list__event-featured-image-wrapper tribe-common-g-col\">\n\t<img\n\t\tclass=\"tribe-events-calendar-list__event-featured-image\"\n\t\tsrc=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/10\/9727-WHD_2026-1200x627-FR-1.jpg\"\n\t\t\t\t\tsrcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/10\/9727-WHD_2026-1200x627-FR-1.jpg 1200w, https:\/\/wfh.org\/wp-content\/uploads\/2025\/10\/9727-WHD_2026-1200x627-FR-1-192x100.jpg 192w, https:\/\/wfh.org\/wp-content\/uploads\/2025\/10\/9727-WHD_2026-1200x627-FR-1-768x402.jpg 768w\"\n\t\t\t\t\t\t\talt=\"\"\n\t\t\t\t\t\t\ttitle=\"9727-WHD_2026-1200&#215;627-FR\"\n\t\t\t\tclass=\"tribe-events-calendar-list__event-featured-image\"\n\t\t\t\t\twidth=\"1200\"\n\t\t\theight=\"628\"\n\t\t\t\/>\n<\/div>\n\n\t\t\t<div class=\"tribe-events-calendar-list__event-details tribe-common-g-col\">\n\n\t\t\t\t<header class=\"tribe-events-calendar-list__event-header\">\n\t\t\t\t\t<h4 class=\"tribe-events-calendar-list__event-title tribe-common-h6 tribe-common-h4--min-medium\">\n\t<a\n\t\thref=\"https:\/\/wfh.org\/fr\/calendar-event\/journee-mondiale-de-lhemophilie-2026\/\"\n\t\ttitle=\"Journ\u00e9e mondiale de l\u2019h\u00e9mophilie 2026\"\n\t\trel=\"bookmark\"\n\t\tclass=\"tribe-events-calendar-list__event-title-link tribe-common-anchor-thin\"\n\t>\n\t\tJourn\u00e9e mondiale de l\u2019h\u00e9mophilie 2026\t<\/a>\n<\/h4>\n\t\t\t\t\t<div class=\"tribe-events-calendar-list__event-datetime-wrapper tribe-common-b2\">\n\t\t<time class=\"tribe-events-calendar-list__event-datetime\" datetime=\"2026-04-17\">\n\t\t<span class=\"tribe-event-date-start\">avril 17<\/span>\t<\/time>\n\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t<div class=\"tribe-events-calendar-list__event-description tribe-common-b2 tribe-common-a11y-hidden\">\n\t<p style=\"padding-bottom: 1rem\">Le 17 avril 2026, la communaut\u00e9 mondiale des troubles h\u00e9r\u00e9ditaires de la coagulation se r\u00e9unira \u00e0 l\u2019occasion de la Journ\u00e9e mondiale de l\u2019h\u00e9mophilie afin de sensibiliser le public \u00e0 tous les troubles h\u00e9r\u00e9ditaires de la coagulation. Le th\u00e8me de cette ann\u00e9e, \u00ab Diagnostiquer : premi\u00e8re \u00e9tape du soin \u00bb, souligne l\u2019importance cruciale du diagnostic, premi\u00e8re \u00e9tape essentielle du traitement et des soins.<\/p>\n<div>\n<a href=\"https:\/\/wfh.org\/fr\/journee-mondiale-de-lhemophilie\/\" target=\"_blank\" rel=\"noopener\"><\/p>\n<p><button style=\"background-color: #f58020;border-radius: 50px;border-width: 0;color: #fff;cursor: pointer;font-family: 'Avenir Heavy', Arial, sans-serif;font-size: 1.1rem;font-weight: normal;padding: 6px 25px\">En savoir plus<\/button> <\/p>\n<p><\/a>\n<\/div>\n<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/article>\n\t<\/div>\n\n<\/li>\n\n\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t<li  class=\"tribe-common-g-row tribe-events-calendar-list__event-row\" >\n\n\t<div  class=\"tribe-events-calendar-list__event-date-tag tribe-common-g-col post-141528 tribe_events type-tribe_events status-publish has-post-thumbnail hentry\"  >\n\t<time class=\"tribe-events-calendar-list__event-date-tag-datetime\" datetime=\"2026-04-19\" aria-hidden=\"true\">\n\t\t<span class=\"tribe-events-calendar-list__event-date-tag-weekday\">\n\t\t\tdim\t\t<\/span>\n\t\t<span class=\"tribe-events-calendar-list__event-date-tag-daynum tribe-common-h5 tribe-common-h4--min-medium\">\n\t\t\t19\t\t<\/span>\n\t<\/time>\n<\/div>\n\n\t<div class=\"tribe-events-calendar-list__event-wrapper tribe-common-g-col\">\n\t\t<article  class=\"tribe-events-calendar-list__event tribe-common-g-row tribe-common-g-row--gutters post-141528 tribe_events type-tribe_events status-publish has-post-thumbnail hentry\" >\n\t\t\t<div class=\"tribe-events-calendar-list__event-featured-image-wrapper tribe-common-g-col\">\n\t<img\n\t\tclass=\"tribe-events-calendar-list__event-featured-image\"\n\t\tsrc=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/04\/CoE-Visuals-Reg-Now-Fr.jpg\"\n\t\t\t\t\tsrcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2025\/04\/CoE-Visuals-Reg-Now-Fr.jpg 1200w, https:\/\/wfh.org\/wp-content\/uploads\/2025\/04\/CoE-Visuals-Reg-Now-Fr-192x100.jpg 192w, https:\/\/wfh.org\/wp-content\/uploads\/2025\/04\/CoE-Visuals-Reg-Now-Fr-768x401.jpg 768w\"\n\t\t\t\t\t\t\talt=\"\"\n\t\t\t\t\t\t\ttitle=\"CoE Visuals &#8211; Reg Now Fr\"\n\t\t\t\tclass=\"tribe-events-calendar-list__event-featured-image\"\n\t\t\t\t\twidth=\"1200\"\n\t\t\theight=\"627\"\n\t\t\t\/>\n<\/div>\n\n\t\t\t<div class=\"tribe-events-calendar-list__event-details tribe-common-g-col\">\n\n\t\t\t\t<header class=\"tribe-events-calendar-list__event-header\">\n\t\t\t\t\t<h4 class=\"tribe-events-calendar-list__event-title tribe-common-h6 tribe-common-h4--min-medium\">\n\t<a\n\t\thref=\"https:\/\/wfh.org\/fr\/calendar-event\/congres-mondial-2026-de-la-fmh\/\"\n\t\ttitle=\"Congr\u00e8s mondial 2026 de la FMH\"\n\t\trel=\"bookmark\"\n\t\tclass=\"tribe-events-calendar-list__event-title-link tribe-common-anchor-thin\"\n\t>\n\t\tCongr\u00e8s mondial 2026 de la FMH\t<\/a>\n<\/h4>\n\t\t\t\t\t<div class=\"tribe-events-calendar-list__event-datetime-wrapper tribe-common-b2\">\n\t\t<time class=\"tribe-events-calendar-list__event-datetime\" datetime=\"2026-04-19\">\n\t\t<span class=\"tribe-event-date-start\">avril 19<\/span> - <span class=\"tribe-event-date-end\">avril 22<\/span>\t<\/time>\n\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t<div class=\"tribe-events-calendar-list__event-description tribe-common-b2 tribe-common-a11y-hidden\">\n\t<p style=\"padding-bottom: 1rem\">La F\u00e9d\u00e9ration mondiale de l'h\u00e9mophilie (FMH) est heureuse d'accueillir la communaut\u00e9 mondiale des troubles de la coagulation au Congr\u00e8s mondial 2026 de la FMH \u00e0 Kuala Lumpur, en Malaisie.<\/p>\n<div class=\"btn-wrapper\"><a href=\"https:\/\/wfh.org\/fr\/congres\/\" target=\"_blank\" rel=\"noopener\"><br \/>\n<button style=\"background-color: #1B75BA;border-radius: 50px;border-width: 0;color: #fff;cursor: pointer;font-family: 'Avenir Heavy', Arial, sans-serif;font-size: 1.1rem;font-weight: normal;padding: 6px 25px\">En savoir plus<\/button><br \/>\n<\/a><a href=\"https:\/\/icsevents.eventsair.com\/wfh2026\/reg\/Site\/Register\" target=\"_blank\" rel=\"noopener\"><br \/>\n<button style=\"background-color: #ED2024;border-radius: 50px;border-width: 0;color: #fff;cursor: pointer;font-family: 'Avenir Heavy', Arial, sans-serif;font-size: 1.1rem;font-weight: normal;padding: 6px 25px\">S'inscrire maintenant<\/button><br \/>\n<\/a><\/p>\n<\/div>\n<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/article>\n\t<\/div>\n\n<\/li>\n\n\t\t\t\t\t\t\t\n\t\t\t\t<li class=\"tribe-events-calendar-list__month-separator\">\n\t<h3>\n\t\t<time\n\t\t\tclass=\"tribe-events-calendar-list__month-separator-text tribe-common-h7 tribe-common-h6--min-medium tribe-common-h--alt\"\n\t\t>\n\t\t\tmai 2026\t\t<\/time>\n\t<\/h3>\n<\/li>\n\n\t\t\t\t<li  class=\"tribe-common-g-row tribe-events-calendar-list__event-row\" >\n\n\t<div  class=\"tribe-events-calendar-list__event-date-tag tribe-common-g-col post-174997 tribe_events type-tribe_events status-publish has-post-thumbnail hentry\"  >\n\t<time class=\"tribe-events-calendar-list__event-date-tag-datetime\" datetime=\"2026-05-17\" aria-hidden=\"true\">\n\t\t<span class=\"tribe-events-calendar-list__event-date-tag-weekday\">\n\t\t\tdim\t\t<\/span>\n\t\t<span class=\"tribe-events-calendar-list__event-date-tag-daynum tribe-common-h5 tribe-common-h4--min-medium\">\n\t\t\t17\t\t<\/span>\n\t<\/time>\n<\/div>\n\n\t<div class=\"tribe-events-calendar-list__event-wrapper tribe-common-g-col\">\n\t\t<article  class=\"tribe-events-calendar-list__event tribe-common-g-row tribe-common-g-row--gutters post-174997 tribe_events type-tribe_events status-publish has-post-thumbnail hentry\" >\n\t\t\t<div class=\"tribe-events-calendar-list__event-featured-image-wrapper tribe-common-g-col\">\n\t<img\n\t\tclass=\"tribe-events-calendar-list__event-featured-image\"\n\t\tsrc=\"https:\/\/wfh.org\/wp-content\/uploads\/2026\/03\/Article-header-LinkedIn-X-FR.jpg\"\n\t\t\t\t\tsrcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2026\/03\/Article-header-LinkedIn-X-FR.jpg 1200w, https:\/\/wfh.org\/wp-content\/uploads\/2026\/03\/Article-header-LinkedIn-X-FR-192x100.jpg 192w, https:\/\/wfh.org\/wp-content\/uploads\/2026\/03\/Article-header-LinkedIn-X-FR-768x401.jpg 768w\"\n\t\t\t\t\t\t\talt=\"\"\n\t\t\t\t\t\t\ttitle=\"Article header, LinkedIn, X &#8211; FR\"\n\t\t\t\tclass=\"tribe-events-calendar-list__event-featured-image\"\n\t\t\t\t\twidth=\"1200\"\n\t\t\theight=\"627\"\n\t\t\t\/>\n<\/div>\n\n\t\t\t<div class=\"tribe-events-calendar-list__event-details tribe-common-g-col\">\n\n\t\t\t\t<header class=\"tribe-events-calendar-list__event-header\">\n\t\t\t\t\t<h4 class=\"tribe-events-calendar-list__event-title tribe-common-h6 tribe-common-h4--min-medium\">\n\t<a\n\t\thref=\"https:\/\/wfh.org\/fr\/calendar-event\/evenement-parallele-a-lams-faire-progresser-lequite-en-sante-pour-les-troubles-de-la-coagulation\/\"\n\t\ttitle=\"\u00c9v\u00e9nement parall\u00e8le \u00e0 l\u2019AMS\u202f: faire progresser l\u2019\u00e9quit\u00e9 en sant\u00e9 pour les troubles de la coagulation\"\n\t\trel=\"bookmark\"\n\t\tclass=\"tribe-events-calendar-list__event-title-link tribe-common-anchor-thin\"\n\t>\n\t\t\u00c9v\u00e9nement parall\u00e8le \u00e0 l\u2019AMS\u202f: faire progresser l\u2019\u00e9quit\u00e9 en sant\u00e9 pour les troubles de la coagulation\t<\/a>\n<\/h4>\n\t\t\t\t\t<div class=\"tribe-events-calendar-list__event-datetime-wrapper tribe-common-b2\">\n\t\t<time class=\"tribe-events-calendar-list__event-datetime\" datetime=\"2026-05-17\">\n\t\t<span class=\"tribe-event-date-start\">mai 17 @ 18h00<\/span> - <span class=\"tribe-event-time\">20h00<\/span>\t<\/time>\n\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t<div class=\"tribe-events-calendar-list__event-description tribe-common-b2 tribe-common-a11y-hidden\">\n\t<p style=\"padding-bottom: 1rem\">Rejoignez-nous le 17 mai pour un \u00e9v\u00e9nement parall\u00e8le intitul\u00e9 \u00ab\u202fFaire progresser l'\u00e9quit\u00e9 en sant\u00e9 pour les troubles de la coagulation\u202f\u00bb lors de la 79e Assembl\u00e9e mondiale de la sant\u00e9 (AMS). Cet \u00e9v\u00e9nement est organis\u00e9 en vue de l\u2019adoption de la r\u00e9solution de l\u2019AMS, men\u00e9e par les \u00c9tats membres, entre le 18 et le 23 mai 2026. Il servira de plateforme de sensibilisation et sera l\u2019occasion d\u2019impliquer les diff\u00e9rents acteurs internationaux de la sant\u00e9 au sujet des obstacles majeurs et des strat\u00e9gies efficaces en mati\u00e8re d\u2019\u00e9quit\u00e9 en sant\u00e9 pour les personnes atteintes d\u2019un trouble h\u00e9r\u00e9ditaire de la coagulation. <\/p>\n<div>\n<a href=\"https:\/\/forms.office.com\/Pages\/ResponsePage.aspx?id=7wqLrLgXcEiZg2eoKmvMP_tNuZpcc3dHv6lfmq7px3FUODJORkVXUUVVSElFWTRRRlg2Tk9GQk9BTC4u\" target=\"_blank\" rel=\"noopener\"><\/p>\n<p><button style=\"background-color: #ed174c;border-radius: 50px;border-width: 0;color: #fff;cursor: pointer;font-family: 'Avenir Heavy', Arial, sans-serif;font-size: 1.1rem;font-weight: normal;padding: 6px 25px\">S'inscrire maintenant<\/button> <\/p>\n<p><\/a>\n<\/div>\n<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/article>\n\t<\/div>\n\n<\/li>\n\n\t\t\t\n\t\t<\/ul>\n\n\t\t<nav class=\"tribe-events-calendar-list-nav tribe-events-c-nav\" aria-label=\"Bottom \u00e9v\u00e8nements list pagination\">\n\t<ul class=\"tribe-events-c-nav__list\">\n\t\t<li class=\"tribe-events-c-nav__list-item tribe-events-c-nav__list-item--prev\">\n\t<a\n\t\thref=\"https:\/\/wfh.org\/fr\/calendar-events\/liste\/?rest_route=%2Fwp%2Fv2%2Fpages%2F22821&#038;shortcode=aa4c05e6&#038;eventDisplay=past\"\n\t\trel=\"prev\"\n\t\tclass=\"tribe-events-c-nav__prev tribe-common-b2 tribe-common-b1--min-medium\"\n\t\tdata-js=\"tribe-events-view-link\"\n\t\taria-label=\"\u00c9v\u00e8nements pr\u00e9c\u00e9dents\"\n\t\ttitle=\"\u00c9v\u00e8nements pr\u00e9c\u00e9dents\"\n\t>\n\t\t<svg\n\t class=\"tribe-common-c-svgicon tribe-common-c-svgicon--caret-left tribe-events-c-nav__prev-icon-svg\" \taria-hidden=\"true\"\n\tviewBox=\"0 0 10 16\"\n\txmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n>\n\t<path d=\"M9.7 14.4l-1.5 1.5L.3 8 8.2.1l1.5 1.5L3.3 8l6.4 6.4z\"\/>\n<\/svg>\n\t\t<span class=\"tribe-events-c-nav__prev-label\">\n\t\t\t<span class=\"tribe-events-c-nav__prev-label-plural tribe-common-a11y-visual-hide\">\u00c9v\u00e8nements<\/span> pr\u00e9c\u00e9dents\t\t<\/span>\n\t<\/a>\n<\/li>\n\n\t\t<li class=\"tribe-events-c-nav__list-item tribe-events-c-nav__list-item--today\">\n\t<a\n\t\thref=\"https:\/\/wfh.org\/fr\/calendar-events\/liste\/?hide_subsequent_recurrences=1&#038;rest_route=%2Fwp%2Fv2%2Fpages%2F22821&#038;shortcode=aa4c05e6\"\n\t\tclass=\"tribe-events-c-nav__today tribe-common-b2\"\n\t\tdata-js=\"tribe-events-view-link\"\n\t\taria-label=\"Cliquer pour s\u00e9lectionner la date du jour\"\n\t\ttitle=\"Cliquer pour s\u00e9lectionner la date du jour\"\n\t>\n\t\tAujourd\u2019hui\t<\/a>\n<\/li>\n\n\t\t<li class=\"tribe-events-c-nav__list-item tribe-events-c-nav__list-item--next\">\n\t<button\n\t\tclass=\"tribe-events-c-nav__next tribe-common-b2 tribe-common-b1--min-medium\"\n\t\taria-label=\"\u00c9v\u00e8nements suivants\"\n\t\ttitle=\"\u00c9v\u00e8nements suivants\"\n\t\tdisabled\n\t>\n\t\t<span 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calendrier\t\t\t<\/button>\n\t\t\t<svg\n\t class=\"tribe-common-c-svgicon tribe-common-c-svgicon--caret-down tribe-events-c-subscribe-dropdown__button-icon\" \taria-hidden=\"true\"\n\tviewBox=\"0 0 10 7\"\n\txmlns=\"http:\/\/www.w3.org\/2000\/svg\"\n>\n\t<path fill-rule=\"evenodd\" clip-rule=\"evenodd\" d=\"M1.008.609L5 4.6 8.992.61l.958.958L5 6.517.05 1.566l.958-.958z\" class=\"tribe-common-c-svgicon__svg-fill\"\/>\n<\/svg>\n\t\t<\/div>\n\t\t<div id=\"tribe-events-c-subscribe-dropdown-content\" class=\"tribe-events-c-subscribe-dropdown__content\">\n\t\t\t<ul class=\"tribe-events-c-subscribe-dropdown__list\">\n\t\t\t\t\t\t\t\t\t\n<li class=\"tribe-events-c-subscribe-dropdown__list-item 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l\u2019h\u00e9mophilie (FMH) est r\u00e9serv\u00e9e aux laboratoires pharmaceutiques fabricant des m\u00e9dicaments et autres produits traitant les [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":19564,"parent":23956,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"inline_featured_image":false,"footnotes":""},"search-category":[],"class_list":["post-22821","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Actualit\u00e9s des Entreprises partenaires | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"description\" content=\"See where you as a manufacturer can post press releases of interest to the global bleeding disorder community.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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