Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market
Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.
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AstraZeneca paid $95m to Swedish Orphan Biovitrum for the voucher, which it could use to expedite the FDA review of roxadustat or trastuzumab deruxtecan.
A worst-case Brexit scenario – a disorderly one – has become more likely, making an already white-knuckled life sciences industry step up its preparations.