Post by Erik Clausen
Strategic Communications Leader | Corporate Reputation, Brand Storytelling & Executive Visibility | Helping Healthcare & Biopharma Brands Build Trust and Influence | Agency Entrepreneur + Executive | Proud Ally
The FDA has fortunately reversed its position yet again and will accept existing trial data for an accelerated review of UniQure's gene therapy for Huntington's disease. The FDA indicated late last year that the available data were insufficient to support a filing, with one senior regulator describing UniQure's therapy as a "failed product." While the reversal is a boon for those seeking treatments and the companies developing them, it further underscores regulatory volatility and the ongoing difficulty the industry has in trusting FDA guidance. [as I wrote about a few months ago in the linked article below] #Biotech #GeneTherapy #RareDisease #FDA #DrugDevelopment #uniqure
