News

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New human fibrinogen concentrate available

FibCLOT, a new human fibrinogen concentrate is now available in the UK, offering increased therapeutic choices for patients affected by congenital fibrino...

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Emicizumab meets study endpoint

22 December 2016 Prophylaxis with emicizumab reduced the number of bleeds over time compared with no prophylaxis in the HAVEN 1 study, which recruited ...

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Elocta and Alprolix gain NHS reimbursement across the UK

21 September 2016 NHS England has confirmed reimbursement of Elocta® (efmoroctocog alfa) and Alprolix® (efrenonocog alfa) for the treatment of haemophilia ...

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Emicizumab data looks encouraging

29 July 2016 Emicizumab, the humanized bispecific monoclonal antibody, in development by Roche/Genentech, continues to look promising for people with s...

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EMA discounts increased inhibitor risk with Kogenate and Helixate

13 May 2016 Currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhib...

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First longer-acting FVIII moves a step closer

28 September 2015 The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the ma...Once approved, Elocta will likely be the first prolonged half-life treatment option available for people with haemophilia A in the UK and Ireland.

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EMA validates Alprolix (rFIXFc) marketing authorisation application

26 June 2015 The European Medicines Agency (EMA) has accepted Swedish Orphan Biovitrum AB (Sobi) and Biogen’s Marketing Authorisation Application for Alproli...

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Sobi launches movie-maker app

Children living with haemophilia sometimes have a hard time talking about their condition or describing the implications the disease has on their life. Sob...

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Bayer recruits children to long-acting trial

Bayer HealthCare has started to enroll children in an international phase III trial to evaluate its investigational compound BAY 94-9027 for the treatment ...

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Another one bites the dust

Bad news for Bayer this week. The company has just announced the discontinuation of a Phase II/III trial evaluating the efficacy and safety of BAY 86-6150 ...

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Baxter to Initiate Late-Stage Trial of Longer Acting Advate

Baxter in the US has submitted an Investigational New Drug (IND) application for its investigational haemophilia A treatment BAX 855 with the US Food and D...

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B-LONG results positive for Biogen/SOBI

Wednesday 26 September 2013: Top-line results from the late-stage B-LONG trial suggest that Biogen/SOBIs’ long-lasting recombinant Factor IX Fc fusion prot...

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New kid on the block looks promising

Pro Bono Bio Group plc has successfully concluded its pre-clinical trials in haemophilia patients using the world's first long acting blood Factors VIIa, V...

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EMA Calls for Further Research on Personalized Approaches to Treating Hemophilia

The European Medicines Agency (EMA) has released a new reflection paper on the risks of adverse immune system reactions in hemophilia patients treated with...

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League table reveals how many NHS patients take part in clinical research

The National Institute for Health Research Clinical Research Network has this week published its annual league table, revealing how many patients are takin...

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Children to be seen (and heard) at EMA paediatric committee

Scrip reports that the European Medicines Agency is planning to allow children to participate in its paediatrics committee (PDCO) meetings to get their fee...

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Inspiration files new FIX in US

Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001,...

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First patient screened in CSL Behring global phase I/III study of recombinant single-chain factor VIII

CSL Behring has screened the first patient in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial prog...

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Inspiration initiates second trial of porcine FVIII

Inspiration Biopharmaceuticals, Inc. has announced the initiation of patient enrolment in the second of two pivotal studies in its OBI-1 Accur8 clinical tr...

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Another gene therapy milestone?

Amsterdam Molecular Therapeutics has announced that the European Medicines Agency (EMA) has granted orphan designation for its gene therapy program for the...

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FEIBA prophylaxis tops on-demand treatment for joint bleeds

Prophylaxis with FEIBA (anti-inhibitor coagulant complex, AICC) significantly and safely decreased the frequency of joint and other bleeding events compare...

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Bio-engineered Protein Shows Promise as New Hemophilia Therapy

A genetically engineered clotting factor that controlled hemophilia in an animal study offers a novel potential treatment for human hemophilia and a broad ...

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Baxter Initiates Phase III Trial of Investigational BAX 111 for the Treatment of von Willebrand Disease

Baxter International Inc. has announced initiation of a Phase III clinical trial to evaluate the safety and effectiveness of BAX 111, Baxter's investigatio...

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Inspiration's $35m payday

The EMA has accepted Inspiration Biopharmaceuticals' marketing app for its new treatment for hemophilia B, triggering a $35 million milestone payment from ...

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Crucial Directives Must be Revised to Protect Patients' Interests and Improve Access to Treatment

The current revision of two European Directives that are crucial to successful research into blood-related diseases must ensure the safety of patients and ...

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Prenatal test extends choice for pregnant women

Pregnant women who carry the haemophilia gene could benefit from a non-invasive prenatal diagnostic test that analyses fetal DNA circulating in the mother’...

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Health reports in UK newspapers "not evidence based"

We may joke about how you can't trust what you read in the press, but inaccurate newspaper reports related to health risk can have real consequences for pa...

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More parents take their kids to A&E

Parents of children with common medical problems are increasingly taking their children to hospital emergency departments rather than waiting to see the GP...

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Most children with head injuries are seen in hospitals not equipped to treat them

More than four fifths of children who turn up at emergency departments with head injuries in the UK are seen in hospitals which would have to transfer them...

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DDAVP “safe in pregnancy”

Desmopressin (DDAVP) appears to be a safe and effective measure for the prevention or treatment of bleeding episodes in pregnant women with bleeding disord...




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