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.
With a US complete response letter for urea cycle disorder therapy ACER-001, rare disease specialty company Acer Therapeutics Inc. holds CRLs for both of the 505(b)(2) new drug applications it has filed – a reminder of the regulatory challenges that can remain for “de-risked” drug candidates with clinical experience in other fields and formulations.
Acer Therapeutics is focused on finding “drugs that were misunderstood” in their original development programs but could have a new...
Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy
Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.
In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.
