Keeping Track: Tauvid, Oriahnn, Artesunate Clear US FDA, Along With Trio Of Pediatric Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.
Positive data from a second Phase III trial will support regulatory filings for linzagolix in the US and Europe, but the GnRH agonist is behind two rival drugs: AbbVie's elagolix and Myovant's relugolix.
Fresenius Kabi’s biosimilar pegfilgrastim rival to Neulasta has been accepted for review by the European Medicines Agency. The firm believes the “milestone” application will pave the way for a 2021 launch.