Pfizer and BioNTech sent in Phase I data for a third dose of BNT162b2 to support future licensure, Gritstone bio will work with CEPI to develop its second-generation vaccine in South Africa and other areas, and Roche Genentech expects a shortage of the drug Actemra to last for several weeks amid a surge in cases.
Authorization for a third dose for immunocompromised patients may have been an initial step toward booster shots of the COVID-19 vaccines, but Pfizer Inc./BioNTech SE have taken a bigger step in submitting the first clinical trial data to the US Food and Drug Administration for approval of a third shot of BNT162b2.
The companies said 16 August that they submitted Phase I safety and immunogenicity data for a third, 30mcg shot of...
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.
