Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa
The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
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ALKS 3831, which combines olanzapine with the mu opioid receptor antagonist samidorphan, was associated with less weight gain compared to olanzapine alone but showed no benefit on metabolic parameters; in advisory committee briefing documents, agency raises theoretical safety concerns about drug’s opioid antagonistic effects in real-world settings.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Public Company Edition: iTeos, Annexon, Nurix and Inozyme went public on 23 July and now CureVac has added its name to the IPO queue for what could be a large offering. Also, BioNTech raises $511.5m as COVID-19 vaccine progresses and PTC gets $650m from sale of risdiplam royalties.