The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective January 1, 2023
Under the terms of the agreement, Biogen will make an upfront payment of US $ 8 million to Xbrane
The companies will continue with their exclusive agreements, including commercialization of their current portfolio
The extended collaboration will provide services relating to small molecules for both Forbion and BGV portfolio companies active in the biopharmaceutical space
This test analyses samples in VTM directly without the need for RNA extraction step
Biogen paid Ionis a US $ 60 million one-time upfront payment
Collaboration aims to develop innovative machine learning and artificial intelligence solutions for personalized and earlier treatment in neurology
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
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