Deals Shaping The Medical Industry, November 2014
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Long Road For Daiichi Sankyo’s Quizartinib Gets Longer As FDA Extends Review Time
The drug could nevertheless find itself in a competitive position if approved for frontline FLT3-ITD acute myeloid leukemia, especially as competitor Astellas’s Xospata has repeatedly stumbled.
Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier
To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.