The US Food and Drug Administration has granted an accelerated approval to Calquence (acalabrutinib), a new kinase inhibitor for the treatment of adults with mantle cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma.
An agreement on the full mutual recognition of pharmaceutical factory inspections was reached on 1 November when the US Food and Drug Administration and the European Commission confirmed that they can now accept one another’s standards.
The US Food and Drug Administration has approved a second gene therapy to treat cancer, giving a further boost to developers of the new technologies. The approval is for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell therapy to treat adults with certain types of large B-cell lymphoma.
Sales of antibiotic drugs for the treatment of animals has declined in Europe against a backdrop of appeals from public health authorities to curb their use in food-producing species. Overuse of these drugs is linked to a rise in bacterial resistance to existing medicines.
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.