AstraZeneca Plc has received an accelerated approval in the US for its checkpoint antibody Imfinzi (durvalumab), which is expected to be the cornerstone of a prospective portfolio of immune oncology products targeting a variety of cancers.
Novartis has secured US approval for a new kinase inhibitor, Rydapt (midostaurin), to treat patients with FLT3-mutated acute myeloid leukaemia (AML) in combination with chemotherapy. The approval also covers a diagnostic designed to detect the mutation.
The European Medicines Agency has issued a positive opinion for the antisense oligonucleotide medicine Spinraza (nusinersen) to treat patients with spinal muscular atrophy, a rare genetic disease that causes muscle weakness and a progressive loss of movement.
Vernalis Plc has had its application for the cough-cold medicine CCP-07 turned back by the US Food and Drug Administration, with the result that the product will not reach the US market as quickly as planned.
The US Food and Drug Administration has turned back an application from Eli Lilly and Company for baricitinib, a candidate treatment for rheumatoid arthritis, saying that more data is needed to determine the most appropriate doses of the drug for use in patients.
The European Medicines Agency EMA) has formalised its ongoing relationship with universities in order to tap into research that could lead to new medicines and provide regulatory guidance to academic entrepreneurs.
Novartis has become the second developer to have a candidate chimeric antigen receptor T (CAR T) cell therapy for cancer accepted by the US Food and Drug Administration for review. If successful, the two applications will mark a new era in cancer therapy.
A monoclonal antibody developed by Genentech (Roche) for multiple sclerosis (MS) has been approved for marketing in the US, the first therapy to show a delay in disability for those with progressive forms of the disease. In clinical trials, Ocrevus performed better than Rebif, the standard of care.
The US Food and Drug Administration has approved a new drug for women with ovarian cancer whose disease has recurred despite treatment with platinum-based chemotherapy. The drug, Zejula (niraparib), is a poly ADP-ribose polymerase (PARP) inhibitor.
Novo Nordisk A/S has received a positive opinion from the European Medicines Agency (EMA) for its new treatment for haemophilia B, a genetic disorder caused by missing or defective factor IX, a blood clotting protein.