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...
New report by global law firm Taylor Wessing and Bayes Business School forecasts a steadily increasing volume of major life sciences M&A in the coming five years, but highlights concerns over cybersecurity and unrealistic valuations. Taylor Wessing partner Andrew Edge spoke to In Vivo.
The Chinese appetite for GLP-1s is noticeable. While the market opportunity for western pharma is huge, so are the strategic market access challenges, though not unsurmountable, L.E.K. Consulting told In Vivo.
Many assets do not meet their pre-launch predictions, either exceeding or falling short of their forecast sales. In this article, In Vivo highlights several historic examples and the factors that influenced their unexpected performance.
