Roche reveals new safety data for haemophilia treatment Hemlibra
No new safety signals identified with longer-term Hemlibra treatment in adult and adolescent patients
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Tag: haemophilia A
BioMarin resubmits haemophilia A gene therapy to the EMA
Company initially withdrew a marketing authorisation application for the gene therapy last year
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EU review extended for BioMarin’s gene therapy Valrox
The EMA has asked for full data from an ongoing Phase III study of the treatment in patients with severe haemophilia A
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Novo Nordisk resumes late-stage haemophilia trials
Clinical trial programme resumes after safety concerns
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EC extends license for Roche/Chugai’s Hemlibra
The European Commission has approved Roche and Chugai Pharma UK’s Hemlibra for the prevention of bleeding episodes in people with severe haemophilia A without factor VIII inhibitors, expanding the drug’s treatment scope.
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EU gives Bayer’s Jivi the green light
Bayer has received EU approval for its hemophilia A treatment, Jivi.
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Use of Roche’s haemophilia A therapy Hemlibra expanded in the US
Roche’s Hemlibra has been approved in the US for routine prophylaxis of bleeding episodes patients with haemophilia A without factor VIII inhibitors.
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Bayer wins US nod for Jivi
US regulators have approved Bayer’s Jivi (formerly BAY94-9027), a longer-acting Factor VIII therapy designed to reduce the number of infusions necessary to prevent bleeds in patients with Haemophilia A.
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Novo files N8-GP in the US and EU
Novo Nordisk has filed regulatory applications in the US and European Union seeking approval to market N8-GP for the treatment of haemophilia
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Roche’s emicizumab cleared for early access in the UK
Roche’s emicizumab in being included in the UK’s Early Access to Medicines Scheme for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors.
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Roche’s Hemlibra reduces bleeds in haemophilia A patients
Roche’s Hemlibra has hit key targets in a Phase III trial assessing its effectiveness in preventing bleeds in adults and adolescents with haemophilia A without inhibitors to factor VIII.
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Roche bags new approvals for Hemlibra, Gazyva
US regulators have issued a green light for Roche’s haemophilia A therapy Hemlibra and also expanded the scope of Gazyva to include untreated advanced follicular lymphoma.
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