J&J’s Spravato Gets EU Okay For Drug-Resistant Depression
Nasal Spray Completes Approval Process Unscathed
Concerns that written interventions might delay the expected EU approval of the novel ketamine-based antidepressant have come to naught.
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The EMA has received written interventions from third parties relating to its CHMP opinion that the controversial antidepressant should receive EU approval.
The two companies can now market their HER-2 targeting antibody-drug conjugate in its second tumor type as they look to expand beyond breast cancer.
The Danish company pockets $40m as the lead asset in the potential multi-billion dollar deal with AbbVie for bi-specific antibodies progresses into Phase III, and while it looks to build up its commercial infrastructure.