Tag Archives: bleeding disorders

May, 2018

4 May
FDA Approves Portola’s Andexxa, the First and Only Antidote for the Reversal of Factor Xa Inhibitors

SOUTH SAN FRANCISCO, Calif., May 03, 2018 (GLOBE NEWSWIRE) — Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due …
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15 December
FDA Lifts Clinical Hold on Alnylam’s Hemophilia Drug Candidate Fitusiran

CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension (OLE) study …
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5 December
Shire’s Vonvendi Succeeds in Late-Stage Study in Patients with Von Willebrand Disease

Lexington, Mass. – December 2, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving individuals with rare diseases and other highly specialized conditions, today announced topline results from a Phase 3 clinical trial of VONVENDITM [von Willebrand factor (Recombinant)] to treat bleeds in elective …
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28 November
UT Austin Engineers Develop First-Ever Capsule to Treat Hemophilia

In the near future, hemophiliacs could be able to treat their disease by simply swallowing a capsule. Thanks to a breakthrough led by researchers in the Cockrell School of Engineering at The University of Texas at Austin, treatment for hemophilia can now be administered via a biodegradable system, a capsule, …
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7 March
CSL’s Idelvion Approved for Treatment of Hemophilia B

KING OF PRUSSIA, Pa. — 04 March 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, CSL Behring’s long-acting recombinant albumin fusion protein, delivers on the company’s promise to develop and …
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14 April
CSL Behring Marks World Hemophilia Day by with Significant Contributions to the World Federation of Hemophilia

In recognition of World Hemophilia Day, held on April 17, CSL Behring announced that it is donating ten million international units (IUs) of bleeding disorder protein therapies and contributing a significant financial contribution to the World Federation of Hemophilia (WFH). CSL Behring said that it has once again committed to …
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17 March
Hemophilia: Not Just a Male Disease

There’s a good reason that hemophilia is linked to men in the minds of most people. Far more men than women are born with this bleeding disorder; but bleeding disorders do affect women too. Here’s the catch: with hemophilia often assumed as a “male” disease, when a woman does have …
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17 March
CSL Behring’s Kcentra Shows Superiority to Plasma in Late-Stage Study

Results from CSL Behring’s late-stage study showing Kcentra’s superiority to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, warfarin) therapy in adult patients needing an urgent surgery or invasive procedure were published in The Lancet. CSL’s Kcentra is the first and …
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