Anadys Pharmaceuticals, Inc.
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Latest From Anadys Pharmaceuticals, Inc.
J&J’s Carvykti Claims Broadest CAR-T Label In Multiple Myeloma
The second-line indication comes with safety labeling recently approved for BCMA-targeted CAR-T competitor Abecma, particularly around increased early mortality and secondary malignancies.
Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data
Labeling describes early death imbalance that delayed approval of Bristol Myers Squibb’s CAR-T therapy for more than three months after its user fee goal, but does not add to boxed warning; J&J’s Carvykti is due for imminent US FDA action on its own early-stage myeloma bid.
BMS’s Abecma Shakes Up Myeloma With Earlier-Line Approval From FDA
The US FDA approved Abecma for multiple myeloma after two prior lines of therapy, while the agency was also expected to imminently decide on earlier-line approval for J&J/Legend’s Carvykti.
Padagis Hit With Immediate Suit After Filing First ANDA For US Zoryve Cream
Tipped to bring in sales of $500m or more by 2030, Arcutis Biotherapeutics’ Zoryve 0.3% cream has become the target of an ANDA filed by Padagis, a partner of Sol-Gel Technologies. The originator responded with an immediate suit to shut down any potential generic launch in the near term.
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