The drug’s journey towards clinical validation has seen significant progress, with approval for Phase I clinical trials in both the US and Korea. SN Bioscience is now poised to submit investigational new drug (IND) applications for Phase II trials in the US and Europe, following encouraging results in pancreatic cancer animal models.
Furthermore, SNB-101’s designation as an orphan drug by the US FDA underscores its potential as a therapeutic breakthrough. This designation provides exclusive marketing rights, tax credits, trial design assistance, and exemption from review application fees, offering significant incentives for its accelerated clinical development.
Despite these advancements, the pharmaceutical landscape faces legislative debates surrounding drug pricing and innovation. US lawmakers in the House of Representatives are deliberating changes to the Inflation Reduction Act (IRA), particularly focusing on the bipartisan Optimizing Research Progress Hope And New (ORPHAN) Cures Act and Maintaining Investments in New Innovation (MINI) Act.
The ORPHAN Cures Act proposes exemptions for orphan drugs exclusively approved for rare diseases, aiming to streamline negotiations. Conversely, the MINI Act seeks to delay negotiations for certain “advanced drug products.” However, concerns have been raised regarding the potential impact of these amendments on innovation within the pharmaceutical industry.
While some argue that the IRA may stifle innovation, others contend that the legislation will ensure access to affordable cures while preserving innovation. The ongoing debate highlights the complexities surrounding drug pricing and regulatory frameworks, with stakeholders advocating for policies that balance access, affordability, and innovation.
As SN Bioscience advances the clinical development of SNB-101, its potential to revolutionize cancer treatment underscores the importance of fostering an environment conducive to innovation within the pharmaceutical industry. Amidst legislative discussions, the pursuit of groundbreaking therapies like SNB-101 remains pivotal in addressing unmet medical needs and improving patient outcomes.
https://www.pharmaceutical-business-review.com/news/sn-bioscience-fda-orphan-drug/
https://endpts.com/house-committee-debates-ira-changes-that-would-impact-orphan-drugs-and-other-areas/
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