SIFI Among EU Fast-Track Hopefuls With ‘World’s First’ Drug For Parasitic Eye Infection
EU Filing For Akantior Planned In Q2
SIFI is set to learn whether the European Medicines Agency will agree that its planned EU marketing application for Akantior merits an accelerated assessment, as is Janssen for its combination treatment for prostate cancer.
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Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.
AstraZeneca and Merck & Co’s latest results put them far ahead of competitors in prostate cancer in reaching patient regardless of their mutational status.