Swedish Orphan Biovitrum AB
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Latest From Swedish Orphan Biovitrum AB
The French firm’s Q4 sales missed consensus due to a slow-down in its vaccine franchise, while analyst concern regarding a pivotal readout for blockbuster product Dupixent in COPD increased.
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
Immix collaborates with Israeli research institutions on BCMA-targeted CAR-T therapy. NeoImmuneTech/NIAID alliance could pave way for “animal rule” approval in acute radiation syndrome.
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