India has waived the need for local clinical trials for COVID-19 vaccines already approved in certain other countries, while the WHO has added a Chinese vaccine to its emergency use list. Meanwhile, South Korea issues new guidance for local vaccine trials and Japan gives more money to COVAX.
In an unprecedented concession to COVID-19 vaccine makers like Pfizer Inc. and Moderna, Inc., the Indian government has waived a requirement for bridging trials even after these vaccines are granted an accelerated approval.
Pfizer in particular has been insistent on not conducting bridging trials and has, in addition, been seeking indemnity from the...
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.
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.
