The FDA granted an expected, though long-awaited, approval to the COVID-19 vaccine. Also, Korean regulators have begun a review of Russian vaccine CoviVac, while Bavarian Nordic has initiated a Phase II study of its vaccine booster candidate and received a commitment for up to DKK 800m from the Danish government.
The US Food and Drug Administration’s full approval of Pfizer Inc./BioNTech SE’s COVID-19 vaccine BNT162b2, now Comirnaty, has expanded the companies’ options for marketing it.
As expected, the FDA granted approval for Comirnaty, the brand name that the companies have used in Europe for months,...
Pfizer/BioNTech and Moderna rapidly adapted Comirnaty and Spikevax for the 2024-2025 season to address the KP.2 variant after the US FDA had advised them to target JN.1 in June.
The companies said their combination mRNA vaccine showed protection against SARS-CoV-2 and influenza A, but not influenza B.
The UK giant’s COVID-19 prophylactic sipavibart could soon reach Europe and competition is sparse.
When life hands a biotech company the equivalent of good grapes, the expectations are for its products to be the equivalent of fine wine. Before that Moderna looks likely to make lemonade.
As clinical trials grow more complex, execution pressures are changing where and how evidence is collected.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
