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Latest From Apotex Inc.
Biogen has been granted new US patents for Tecfidera after generics already launched. It's unclear how Biogen will proceed but management could shed more light on the matter during the first quarter call.
Apotex fell again in its bid to prove that a key patent in Canada shielding Janssen’s Zytiga (abiraterone acetate) treatment for prostate cancer was obvious. However, the company had already succeeded in obtaining a marketing authorization in a separate action.
The European Medicines Agency is expected to decide soon whether Amarin’s fish oil pill, Vascepa, should win pan-EU marketing approval for reducing cardiovascular risk.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
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