Latest From Maureen Kenny
Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.
One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.
EU trade expert Hervé Jouanjean considers the reasoning behind the EU’s vaccine procurement approach and Italy's decision to block exports of AstraZeneca's COVID-19 vaccine.
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.