Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles
A Regulatory Case-Study
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.
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Keeping Track: Longer US FDA Reviews For Tislelizumab, Toripalimab, Olipudase; Perrigo Wants OC To Go OTC
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.