Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections
Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.
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Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.
Public Company Edition: Lilly’s COVID-19 antibody partner AbCellera launched one of the biggest IPOs of 2020, bringing in $483m. Also, two more SPACs went public; Sinovac, Biocryst and Kura Oncology arranged large financings; and Viatris plans post-merger layoffs.