EniferAs the first Nordic company seeking Novel Food approval for a mycoprotein ingredient, Finnish Enifer has filed a authorisation application for it brand PEKILO to the EU food watchdog EFSA.
Tag Archive for: EMA
Bavarian Nordic A/SDanish vaccine maker Bavarian Nordic A/S has submitted data to the EMA that support label extension of its mpox vaccine imvanex indication to include adolescents 12 to 17 years of age.
The European Commission has fully upheld the complaint by PharmaMar SA due to conflicts of interest of leading EMA experts in the (non-)authorisation of Aplidin.
EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.
Born with the aim of harmonising the application, evaluation, and supervision process of clinical trials conducted in EU countries, there is much room for improvement for the Clinical Trial Information System CTIS, particularly with regard to SMEs and translational researchers.
In 2016, PharmaMar filed a European marketing authorisation application for Aplidin as a treatment for patients with multiple myeloma. After the European Medicines Agency rejected the MAA twice, which was accepted in Australia with the same data, PharmaMar sued the EC. European Biotechnology spoke with PharmaMars Chairman José María Fernández Sousa-Faro.