Draft NICE decision rejects Respreeza for incurable, genetic disorder

27 September 2018 - NICE has published draft guidelines rejecting NHS use of CSL Behring’s Respreeza for treating emphysema in ...

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Aronora's new blood clot treatment receives FDA fast track designation

26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...

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Bayer receives positive CHMP opinion for its haemophilia A treatment BAY94-9027

21 September 2018 - The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical ...

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Highlights from the 17-20 September CHMP meeting

21 September 2018 - CHMP elects new chair and recommends thirteen medicines for approval. ...

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Shire granted EU marketing authorization for Veyvondi [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease

12 September 2018 - Marketing authorisation will enable patient access to Veyvondi throughout Europe. ...

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FDA approves Grifols new GamaSTAN (immunoglobulin [human]) to treat patients exposed to hepatitis A and measles

4 September 2018 - New formulation is manufactured using Grifols' sophisticated caprylate chromatography process according to the highest quality and safety ...

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Bayer receives US approval for modern haemophilia A treatment Jivi with a step-wise prophylaxis dosing regimen

30 August 2018 - Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and ...

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ICER releases draft evidence report on long-term treatments for prevention of hereditary angioedema attacks

23 August 2018 - Public comment period now open until 20 September; requests to make oral comment during public meeting also ...

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ADMA Biologics receives PDUFA date for Bivigam regulatory submission

26 July 2018 - Prior approval supplement to amend the biologics license application for Bivigam is supported by data and documentation ...

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RFP - supply of recombinant factor VIII, recombinant factor IX and bypassing agents for the treatment of haemophilia

23 July 2018 - PHARMAC invites proposals for the supply of Recombinant Factor VIII, Recombinant Factor IX and bypassing agents (Recombinant ...

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CHMP recommends EU marketing authorisation for Veyvondi [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease

2 July 2018 - Veyvondi is currently only approved in the US for adults with VWD. ...

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Shire announces FDA approval for label expansion of Cinryze (C1 esterase inhibitor [human]) for prevention of attacks in paediatric hereditary angioedema patients

21 June 2018 - Shire is the only drug developer to complete a paediatric study for the prophylactic treatment of hereditary ...

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Octapharma announces approval of new Nuwiq product strengths in Europe, increasing dosing flexibility for patients with haemophilia A

18 June 2018 - Octapharma announced today that the EMA has approved an extension of marketing authorisation for its human cell ...

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Idelvion newly approved 3,500 IU vial to provide convenience to patients using larger volumes

31 May 2018 - New vial option delivers on CSL Behring’s promise to enhance current treatments and provide more alternatives to ...

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FDA accepts supplemental biologics license application and grants priority review for prophylactic and paediatric use for Bio Products Laboratory's Coagadex (coagulation factor X, human) for treatment of hereditary factor X deficiency

23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency. ...

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