AstraZeneca Buys Priority Review Voucher With Two Big Filings On The Horizon
AstraZeneca paid $95m to Swedish Orphan Biovitrum for the voucher, which it could use to expedite the FDA review of roxadustat or trastuzumab deruxtecan.
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Rare Pediatric Disease Designations May Be Unavailable After July As Program Renewal Remains Uncertain
Without new legislation, US FDA said that designations, which are required to receive priority review vouchers, cannot be assured if requested after July. While the window for designations formally closes at the end of September when the authorization of the program expires, the agency is telling sponsors that it needs 60 days before that to review any requests. If a product does get a designation, it would need to secure approval by 30 September 2022 to gain a priority review voucher.
Ruud Dobber oversees AstraZeneca’s biopharmaceuticals division, which generates some 40% of group total revenues. He tells Scrip to “Watch this space.”
Buying two vaccines for rabies and tick-borne encephalitis complements the recently approved smallpox and monkeypox vaccine Jynneos. Now the Danish firm needs to start selling them.