Spark Therapeutics Inc’s gene therapy for the treatment of inherited retinal dystrophy has received the unanimous backing of an advisory committee of the US Food and Drug Administration ahead of the agency’s decision on marketing in early 2018.
The General Affairs Council of the European Union is expected to decide on a new location for the European Medicines Agency on 20 November following the UK’s decision to leave the union, known as Brexit. The EMA is currently based in London.
The European Medicines Agency has recommended two new cancer drugs for approval in Europe, each with an entirely different mechanisms of action. The first is a PARP inhibitor for ovarian cancer and the second, a photodynamic therapy for prostate cancer.
Novo Nordisk A/S has reached an agreement with the US government and several states to pay $58.65 million to settle claims of mis-communication over the risks of Victoza, its glucagon-like peptide-1 (GLP-1) drug for Type 2 diabetes. The settlement was announced on 5 September.
The US Food and Drug Administration has given its approval to Novartis’ gene therapy for the treatment of paediatric and young adult acute lymphoblastic leukaemia (ALL), Kymriah (tisagenlecleucel). It is the first decision of its kind for a technology that has achieved remissions for a significant number of very ill patients.
The US Food and Drug Administration has taken steps to curb the activities of unlicensed stem cell clinics while preparing for the roll-out in the autumn of a new regulatory framework for developers of cell and tissue-engineered products.
Bayer AG’s proposed $66 billion acquisition of Monsanto Co has hit a roadblock following a decision by the European Commission to investigate whether the new group could reduce competition for pesticides, seeds and genetically-engineered plant traits.
The US Food and Drug Administration has approved Besponsa (inotuzumab ozogamicin), an antibody-drug conjugate, to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Imbruvica (ibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor developed by Pharmacyclics LLC, has received a further approval in the US – this time to treat adult patients with chronic graft versus host disease (cGVHD).
The US Food and Drug Administration has approved Idhifa (enasidenib), a new targeted therapy from Celgene Corp for treating patients with relapsed or refractory acute myeloid leukaemia (AML). Also approved is a diagnostic that can detect a specific genetic mutation.