Latest From Maureen Kenny
There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.
The UK Thalassaemia Society says that HTA body NICE fails to properly incorporate patient experiences into its decision making and that its patient engagement processes need reform. The marketing of Zynteglo, the gene therapy from bluebird bio for which the group is advocating, has just been temporarily suspended.
Bristol Myers Squibb says it is common for cell and gene therapies to revert to the standard timetable as ide-cel follows liso-cel in losing its accelerated assessment status at the European Medicines Agency. Separately, the company has discontinued development of orva-cel, a CAR-T cell therapy that was earlier in the development pipeline.
Switzerland's medicines agency says it wants to see more data on AZD1222 before it can approve the vaccine. Also, a rolling review of Novavax's NVX-CoV2373, yet another COVID‑19 vaccine, is under way at the European Medicines Agency.
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
Global Blood Therapeutics' EU marketing application for Oxbryta (voxelotor) will undergo standard review once it is filed after the company failed to secure fast-track status for the sickle cell disease treatment. Only one product was granted accelerated assessment in October and November.