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Latest From Adolor Corporation
Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles
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.
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
Takeda Moves Takhzyro Toward Dominant Position In Pediatric HAE
The company announced data from the Phase III SPRING study of Takhzyro in children aged 2-11; there is no approved long-term prophylactic therapy for children under 6.
4D Pharma Is Latest Biotech Casualty After Creditor Calls Time
The UK biotech looks to have reached the end of the road, despite some encouraging signs from its microbiome-based pipeline.