Updates from the holiday season include a Phase III failure for Pfizer's MRSA vaccine, AbbVie's submission of upadacitinib for rheumatoid arthritis and several year-end US approvals and FDA actions.
Braeburn Pharmaceuticals Inc. said on Dec. 23 that the US FDA approved its buprenorphine depot injection Brixadi for patients undergoing treatment for moderate to severe opioid use disorder (OUD), but it was a tentative approval that delays the launch and yields additional competitive ground to Indivior PLC's Sublocade (buprenorphine extended-release).
The agency issued a complete response letter (CRL) for Brixadi (CAM2038) in January, requesting more information – though not another...
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
GSK will assume full control of mRNA shots in infectious disease, allowing CureVac to cut costs and pivot its research to oncology.
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.
