Novartis may very well have the first CAR-T therapy approved in the US, beating its rival Kite Pharma to the finish line, since the FDA has accepted the Swiss big pharma's BLA for priority review. Kite says it will complete its rolling BLA submission in a different indication by the end of March.
Novartis AG shot ahead of Kite Pharma Inc. in the race to get the first chimeric antigen receptor T cell (CAR-T) therapy approved in the US for hematological malignancies, announcing on March 29 that its biologic license application (BLA) for CTL019 (tisagenlecleucel-T) has been accepted by the FDA for priority review.
Kite, meanwhile, remains on track to complete its rolling BLA submission for axicabtagene ciloleucel (KTE-C19; axi-cel) by the end of...
The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.
In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
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.
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