Latest From Maureen Kenny
A number of advanced therapies are likely to be approved in the EU this year.
European drug reviewers are not convinced that AstraZeneca and Amgen's investigational treatment for severe asthma, tezepelumab, should be fast-tracked through the EU evaluation system once the companies file for approval.
Calliditas Therapeutics' lead product candidate Nefecon will be fast-tracked at the EMA once the marketing application is filed. Takeda and Bayer are hoping for the same success with aribavir and copanlisib respectively.
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.