Latest From Maureen Kenny
Rolling reviews are now in progress at the European Medicines Agency for four COVID-19 vaccines and for four potential COVID-19 treatments.
PTC Therapeutics is one of many companies in the life sciences sector whose regulatory targets have been adversely affected by the coronavirus pandemic.
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.