US pandemic flu vaccines approved as supplemental BLAs
This article was originally published in Scrip
The US FDA approved the four pandemic flu (2009 H1N1 influenza virus) vaccines yesterday as supplemental biologics license applications (sBLAs). These feature virus strain changes to the manufacturers' conventional seasonal influenza vaccines, in a regulatory process that has similarities to the "mock-up" route being followed in Europe.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.