Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Biologics manufacturing to expand the Aragen platform by offering “gene to GMP” solution
The companies plan to start a pivotal Phase 3 trial in the coming months
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity
Good momentum in commercial CDMO business
The two-part production system is proven to yield high-quality proteins from GS-CHO cell lines, a prevalent mammalian host cell for protein production
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The positive safety review from the DSMB enables the trial to move forward as planned, with an estimated completion date in December 2023
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