Amylyx Pharmaceuticals (Nasdaq:AML) has received Health Canada approval for Albrioza (AMX0035). The FDA is anticipated to decide on Albrioza, which consists of sodium phenylbutyrate and ursodoxicoltaurine, by September 29, 2022. Amylyx is the first new therapy for ALS to win approval in Canada since 2018. The approval also is the first global regulatory approval for…
Medicago and GSK win approval from Health Canada for adjuvanted plant-based COVID-19 vaccine
GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine. Known as Covifenz, the vaccine makes use of plant-based virus-like…
Health Canada authorizes AstraZeneca’s COVID-19 vaccine
Health Canada today authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University — the third vaccine for the novel coronavirus authorized in Canada. “This is very encouraging news. It means more people vaccinated, and sooner. Because for AstraZeneca, just like we were for Pfizer and Moderna, we are ready to get doses rolling,” said…