“Orphan drug development can often be more profitable, entail lower risk and result in faster time to approval than non-orphan therapeutics. Our strategy involves leveraging the 505(b)(2) pathway which we believe will lower cost and allow for a faster approval process by allowing us to bypass Phase 1 trials and immediately initiate Phase 2 clinical trials. It also potentially mitigates risk from a CMC, safety and clinical development standpoint, and offers greater flexibility from the FDA.”
Dr. Jonathan Kaufman, CEO of Lipella Pharmaceuticals
“We are excited to have been granted Orphan Drug Designation for two candidates targeting serious rare diseases that have a significant impact on patients’ lives and currently have no approved treatment. Our goal is to deliver safe and effective treatments as quickly as possible to the patients who need them most,” said Dr. Kaufman.
Dr. Kaufman discusses the strength of the company’s clinical pipeline, which has expanded significantly over the past 12 months
Lipella Pharmaceuticals: Expanded Clinical Pipeline Targets Significant Unmet Need - Prism MarketView
BioStem Technologies, a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived allografts for advanced wound care, is working to change lives for the better with its innovative technology and products.
Read More
