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Luxturna (voretigene neparvovec), first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene recommended for authorisation by EMA

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children suffering from inherited retinal dystrophy caused by RPE65 gene mutations, a…

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New medicine to treat infections in adults: Vabomere, a combination of an antibiotic and new beta-lactamase inhibitor, addresses bacterial resistance.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults: Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection…

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Nerlynx, neratinib, a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery.

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. It is intended for use only in breast…

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Vyxeos (daunorubicin and cytarabine) Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia

Jazz Pharmaceuticals plc has announced that the European Commission approved Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is an advanced liposomal formulation…

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