Topical Cocaine Provides US FDA With First Case Of ‘Dueling’ 505(b)(2) NDAs
Lannett and Genus’s battle parses the distinction between NMEs and NCEs and the meaning of US Hatch-Waxman exclusivity.
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Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.