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Product Development Using the NDA 505(B)(2) Pathway
A 505(b)(2) application is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This approach can lead to approval in a fraction of the time and cost required by traditional paths. For 505(b)(2) in particular, early assessment and preparation are key to identifying needs and avoiding redundancies to set the path to a profitable product. Pre-investigational new drug (PIND) meetings serve as a prudent step in this process and can guide development strategies that reduce time to market and can all but eliminate the possibility of clinical holds.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
