AstraZeneca to Buy US FDA Priority Review Voucher for $95 Million
22 August 2019 - 4:58PM
Dow Jones News
By Ian Walker
AstraZeneca PLC (AZN.LN) said Thursday that it has agreed to buy
a U.S. Food and Drug Administration priority review voucher for $95
million from a subsidiary of Swedish Orphan Biovitrum AB
(SOBI.SK).
A PRV enables the holder to a FDA priority review of a single
new drug application or biologics license application, reducing the
target review time and potentially lead to an expedited
approval.
The pharmaceutical giant said the acquisition is subject to
clearance under the Hart-Scott Rodino Antitrust Improvements
Act.
Write to Ian Walker at ian.walker@wsj.com
(END) Dow Jones Newswires
August 22, 2019 02:43 ET (06:43 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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