Actualités des Entreprises partenaires

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Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress
BASEL - July 9, 2019—Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for Hemlibra® (emicizumab) across multiple pivotal studies in people with haemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on 6-10 July in Melbourne, Australia. In total, Roche presented 21 abstracts from its haemophilia programme, including five oral presentations. Further data from the four pivotal HAVEN clinical trials were presented, demonstrating the long-term safety, efficacy and quality of life benefit of Hemlibra in people with haemophilia A with and without factor VIII inhibitors. Roche also presented the first interim analysis from the phase IIIb STASEY study, reinforcing the safety profile of Hemlibra in adults and adolescents (aged 12 years or older) with haemophilia A with factor VIII inhibitors seen in the HAVEN 1 clinical trial. LINK


Takeda Unveil New Data from the PROPEL Study at ISTH 2019, Reinforcing the Potential Benefit for Personalized Prophylaxis with ADYNOVATE in Severe Hemophilia A
CAMBRIDGE, MA, and OSAKA, JAPAN - July 8, 2019—Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”), R&D-driven, global biopharmaceutical company with a leadership position in rare diseases, has today announced updated results from its phase IIIb/IV clinical trial for ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] at the 27th Annual International Society on Thrombosis and Haemostasis Congress (ISTH), in Melbourne, Australia. The PROPEL study is a PROspective, randomized, multi-center study comparing the safety and efficacy of ADYNOVATE following PK-guided prophylaxis targeting two different Factor Eight (FVIII) trough activity Levels in subjects with severe hemophilia A. PDF


Sanofi Genzyme presented positive Data from Completed Phase 1/2a study of BIVV001 at ISTH 2019
CAMBRIDGE, MA - July 7, 2019—Positive data from the completed Phase 1/2a EXTEN-A study of BIVV001 (rFVIIIFc-VWF-XTEN) showed a single 65 IU/kg dose of BIVV001 achieved average factor activity levels of 17% at seven days post infusion and significantly extended the halflife of factor VIII to 43 hours. These data were presented today at an oral session of the XXVII Congress of the International Society on Thrombosis and Haemostasis (ISTH 2019) taking place in Melbourne, Australia. PDF


The World Federation of Hemophilia (WFH) welcomes Bayer to the WFH Humanitarian Aid Program
MONTREAL - May 23, 2019—The WFH Humanitarian Aid Program aims to improve the lack of access to care and treatment for people with inherited bleeding disorders in developing countries, and is a critically important endeavour for the bleeding disorders community. Today, the World Federation of Hemophilia (WFH) and WFH USA are proud to announce that Bayer has joined the WFH Humanitarian Aid Program. PDF


World Hemophilia Day: Sanofi Genzyme Donation Impacts Patients Across the Globe
April 17, 2019—Nearly 17,000 patients in 40 developing countries have received treatment since donations began in 2015. On World Hemophilia Day April 17th, the global bleeding disorders community unites to raise awareness and understanding of hemophilia and areas of unmet needs for patients. Hemophilia is a rare, genetic bleeding disorder in which the ability of a person’s blood to clot is impaired, which can lead to bleeding episodes that can cause pain, irreversible joint damage, and life-threatening hemorrhages. Hemophilia most often occurs in boys, and there is currently no cure. PDF


European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
BASEL -  March 14, 2019—Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. Hemlibra can be used in all age groups, and can also now be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors. PDF


Precision BioLogic’s CRYOcheckTM Factor VIII Inhibitor Kit Cleared for Sale in U.S.
HALIFAX -  March 13, 2019—Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce FDA 510(k) clearance and the launch of its CRYOcheck Factor VIII Inhibitor Kit in the U.S. This clearance follows approvals received from regulatory authorities in Canada, the European Union, Australia, and New Zealand, where the kit launched in February of this year. PDF


Roche enters into definitive merger agreement to acquire Spark Therapeutics
BASEL -  February 25, 2019—Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) today announced that they have entered into a definitive merger agreement for Roche to fully acquire Spark Therapeutics at a price of US$ 114.50 per share in an all-cash transaction. PDF


Precision BioLogic Launches Product to Improve Inhibitor Testing for People with Hemophilia A
HALIFAX -  February 11, 2019—Precision BioLogic Inc., a leading developer of hemostasis diagnostic products, is pleased to announce the availability of its new CRYOcheck Factor VIII Inhibitor Kit in Canada, the European Union, Australia, and New Zealand following market authorization by Health Canada and respective in-country regulatory authorities last month. PDF


Roche joins the World Federation of Hemophilia Humanitarian Aid Program
BASEL -  February 6, 2019—Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has joined the World Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment for people with inherited bleeding disorders in developing countries. PDF


CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
BASEL -  February 5, 2019—Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra®(emicizumab) for routine prophylaxis of bleeding episodes in adults and children with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. The CHMP has also recommended that Hemlibra can be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors. PDF


CSL Behring Extends Support of World Federation of Hemophilia Programs
MONTREAL and KING OF PRUSSIA -  February 4, 2019—The World Federation of Hemophilia (WFH) and global biotherapeutics leader CSL Behring today announced that the company has renewed its commitment as a Visionary Corporate Partner with WFH for another 3 years. CSL Behring was the first biotherapeutics leader to make a multiyear promise to WFH, an international not-for-profit organization that works to improve the lives of people with hemophilia and other inherited bleeding disorders. PDF

BIVV001 Phase 1/2a Data Presented at ASH Underscore Potential for Once Weekly Dosing with Sustained High Factor Levels in Hemophilia A
SAN DIEGO, CALIF. -  December 3, 2018—Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, today presented new data from the EXTEN-A Phase 1/2a trial of BIVV001 (rFVIIIFc-VWF-XTEN) showing that a single 65 IU/kg dose of BIVV001 extended the half-life of factor VIII to an unprecedented 44 hours with high factor activity levels and was generally well tolerated. The data were presented in an oral session at the 60th Annual Meeting of the American Society of Hematology (ASH). PDF


At ASH, Extended Half-Life Therapies ELOCTATE® and ALPROLIX® Demonstrate Proven Efficacy and Well-Characterized Safety over Four Years 
SAN DIEGO, CALIF. - December 1, 2018—Bioverativ Inc., a Sanofi company, and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced the final results of ASPIRE and B-YOND, the most comprehensive long-term studies of extended half-life factor therapies in hemophilia. The data from both studies confirm the established safety and sustained efficacy of ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, and ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] over four years of treatment in previously treated adult, adolescent, and pediatric patients with severe hemophilia A and B, respectively. These results were presented at the 60th Annual Meeting of the American Society of Hematology (ASH). PDF


Bayer receives positive CHMP opinion for its hemophilia A treatment BAY94-9027
BERLIN, September 21, 2018—Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended BAY94-9027 for the marketing authorization for treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia A. PDF


Bayer’s Jivi® approved in Japan for hemophilia A 
BERLIN, September 21, 2018—Bayer announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Jivi® (BAY94-9027) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. PDF


Bayer receives US approval for modern hemophilia A treatment Jivi® with a step-wise prophylaxis dosing regimen 
BERLIN, August 30, 2018—Bayer announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older in the U.S. PDF


Working to Improve Hemophilia A Testing: Precision BioLogic presents new data at the 64th Annual SSC meeting 
HALIFAX, July 19, 2018—Precision BioLogic today unveiled data from a study using a new kit for a Modified Nijmegen-Bethesda Assay (MNBA) at the International Society on Thrombosis and Haemostasis’ Scientific and Standardization Committee (SSC) meeting in Dublin. PDF


Bioverativ Presents Preliminary Phase 1/2a Data on BIVV001, the First Factor VIII Therapy to Break Through the VWF Half-life Ceiling in Hemophilia A
WALTHAM, Mass. – May 21, 2018 - Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, today presented initial clinical data for BIVV001 (rFVIIIFc-VWF-XTEN), a novel and investigational von Willebrand factor (VWF)-independent factor VIII therapy for people with hemophilia A. PDF
Bioverativ Highlights the Impact of Humanitarian Aid in Hemophilia 
WALTHAM, Mass. , April 17, 2018 — Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, joins the global hemophilia community in recognizing World Hemophilia Day 2018. To honor this year’s theme, Sharing Knowledge Makes Us Stronger, Bioverativ is sharing the stories of people with hemophilia in the developing world and highlighting the life-changing impact treatment can make. PDF
Precision BioLogic Lights It Up Red in Support of World Hemophilia Day
HALIFAX, April 17, 2018 — Precision BioLogic is pleased to support the World Federation of Hemophilia (WFH) and World Hemophilia Day. In recognition of World Hemophilia Day 2018, Precision BioLogic is lighting its offices up in red and encouraging everyone to visit the WFH eLearning Platform to learn more about hemophilia and other bleeding disorders. PDF
Grifols donates over 25 million international units of blood clotting factor in 2017 – Part of an eight-year commitment to WFH; Changing the lives of people with hemophilia in 47 countries with limited access to treatment
Barcelona, Spain (April 16, 2018) — Today, Grifols, S.A. (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS) announced it has donated over 25 million international units(IU) of blood clotting factor medicines over the last year.This donation is part of Grifols’ commitment to provide a minimum of 200M IU to the World Federation of Hemophilia (WFH) Humanitarian Aid Program over eight years starting in 2014. An estimated 400,000 people around the world have hemophilia, yet only 25% receive adequate treatment. PDF

Precision BioLogic Presents New Approach to Standardize and Improve Inhibitor Testing for People with Hemophilia A
HALIFAX, March 13, 2018 – Precision BioLogic, in collaboration with Roche and Genentech, a member of the Roche Group, unveiled data from the study of a new kit for a modified Nijmegen-Bethesda Assay (MNBA) at the Thrombosis & Hemostasis Societies of North America (THSNA) summit in San Diego, California last week. Recognizing the need to standardize and improve Factor VIII (FVIII) inhibitor testing for people with hemophilia A, the companies collaborated on the development of the new MNBA kit and the recent study. PDF

New Data Show Extended Prophylactic Dosing with ALPROLIX® Provides Safe and Effective Protection in People with Severe Hemophilia B
ATLANTA – December 11, 2017 – Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) today announced the results of a new, post-hoc longitudinal analysis demonstrating that individualized dosing with extended half-life therapy, ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], every 14 or more days may be a potential option for people with severe hemophilia B who seek the benefits of protection from a prophylactic therapy with reduced treatment burden. PDF


Study Shows Weekly Prophylactic Treatment with ELOCTATE® Resulted in Bleed Protection and Target Joint Resolution in People with Hemophilia A 
ATLANTA– December 10, 2017 – Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) today announce the results of a new, post-hoc, longitudinal analysis of the pivotal Phase 3 A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its extended half-life therapy ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, has the potential to provide improved bleed protection over episodic treatment, resolve target joints and reduce the treatment burden associated with more frequent dosing intervals. PDF


ALPROLIX® Demonstrates Higher Tissue Distribution and Retention in Joints Compared to Other Factor IX Molecules in a Preclinical Imaging Study
ATLANTA – December 9, 2017 – Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced findings from a novel imaging study investigating extravascular distribution of factor IX therapies, including its leading extended half-life therapy, ALPROLIX® [Antihemophilic Factor IX (Recombinant), Fc Fusion Protein]. PDF


FDA approves Roche’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors
Basel, 16 November 2017 – Roche today announced that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. PDF


Interim Data Published in Haemophilia Show Improvements in Long-Term Joint Health for Hemophilia A Patients Following Prophylactic Treatment with ELOCTATE®
WALTHAM, Mass. & STOCKHOLM, Sweden – 31 October 2017 – Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) today announced the publication of interim results from a longitudinal study of joint health in patients treated prophylactically with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, for treatment of hemophilia A. PDF


Bioverativ and Bicycle Therapeutics enter into strategic research collaboration to develop therapies for hemophilia and sickle cell disease
WALTHAM, Mass. and CAMBRIDGE, U.K., 6 September 2017 – Bioverativ Inc. (NASDAQ: BIVV), a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, and Bicycle Therapeutics Ltd., a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, today announced a research collaboration focused on the discovery, development and commercialization of innovative therapies for hemophilia and sickle cell disease. PDF


Roche announces positive interim results for emicizumab in phase III study of children with haemophilia A
Basel, 17 April 2017 - Roche announced today interim results from the phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with haemophilia A and inhibitors to factor VIII. PDF


Grifols Donates 140 Million International Units of Blood Clotting Factors to the World Federation of Hemophilia Humanitarian Aid Program
17 April 2017 – Today, Grifols, announced that it will donate a minimum of 140 million international units (IU) of blood clotting factor medicines (Factor VIII) to the World Federation of Hemophilia (WFH) Humanitarian Aid Program over the next five (5) years. This announcement is a continuation of the Company’s three-year commitment from 2014, bringing the total humanitarian aid commitment to more than 200M IU of Factor VIII over eight years. PDF


Improving Access to Lifesaving Treatments for Bleeding Disorders in the Developing World 
10 April 2017 –
The World Federation of Hemophilia (WFH) and global biotherapeutics leader CSL Behring announced today that CSL Behring has shipped more than 4 million international units (IUs) of its medicines to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program in recognition of World Hemophilia Day. PDF


Bioverativ Launches as Global Biotechnology Company Dedicated to Meaningful Progress in Hemophilia 
Waltham, Mass. – 1 February 2017 – Today, Bioverativ Inc. (NASDAQ: BIVVV) launches as an independent, global biotechnology company focused on the discovery, development, and commercialization of innovative therapies for hemophilia and other rare blood disorders. PDF

Novo Nordisk to present 28 abstracts at the World Federation of Hemophilia Congress 
Bagsværd, Denmark, 11 July 2016 – Novo Nordisk announced today that data from 28 abstracts will be shared at the upcoming WFH Congress in Orlando, Florida, from 24 to 28 July. The WFH Congress is the largest international meeting for the global bleeding disorders community, taking place every second year. PDF


U.S. FDA Approves CSL Behring’s AFSTYLA®--The First and Only Recombinant Factor VIII Single Chain Therapy for Hemophilia A
KING OF PRUSSIA, Pa., 26 May 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. PDF


European Commission Approves IDELVION®  –  CSL Behring’s Novel Hemophilia B Treatment with Up to 14-day Dosing Intervals 
MARBURG, Germany – 11 May 2016 – CSL Behring announced today that the European Commission has approved IDELVION® [albutrepenonacog alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). PDF


CSL Behring Marks World Hemophilia Day by Donating IUs of Its Specialty Biotherapeutics for Bleeding Disorders to World Federation of Hemophilia 
MONTREAL and KING OF PRUSSIA, Pa. – 13 April 2016 – “Treatment for All is the Vision for All” is the WFH global message for World Hemophilia Day this year (April 17, 2016). The WFH and global biotherapeutics leader CSL Behring announced today that CSL Behring has shipped more than 1.5 million international units (IUs) of its specialty biotherapeutics to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program and other WFH programs. PDF


U.S. FDA Approves CSL Behring’s IDELVION® - The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals
KING OF PRUSSIA, Pa. – 4 March 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B. PDF


CSL Behring’s Long-acting rIX-FP for Hemophilia B - IDELVION® - Receives Positive Opinion from European Medicines Agency CHMP
MARBURG, Germany – 29 February 2016 – Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for IDELVION® (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) for patients with hemophilia B. PDF