Oncology Products with Purpose
Shorla Oncology’s innovative oncology pipeline addresses drug shortages and treatments inadequate for the target population by reinventing & rethinking existing oncology medications with the goal of improving the lives of patients around the globe.
Our development strategy of rethinking approved pharmaceuticals primarily through the 505 (b)(2) regulatory pathway provides a focused strategy that can dramatically reduce clinical burden, cost & risk while maximizing speed to market.
At Shorla Oncology we have built a flexible go-to-market strategy, enabling us to commercialize our oncology portfolio in a cost-efficient manner coupling in-house expertise and market leading external commercial partners. With this highly adaptable team & infrastructure we can remain flexible and assess the optimal commercialization strategy on a case-by-case basis to maximize the return on investment for our oncology portfolio.
Shorla Oncology have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (‘FDA’) on our oncology drug SH-105. The FDA’s prompt and definitive response confirms our clinical and regulatory strategy and aligns with our plan to accelerate the filing of our New Drug Application (‘NDA’). Having recently completed a successful type C meeting with the Food and Drug Administration (FDA), development is on track for NDA submission later this year
Shorla Oncology have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (FDA) on our third oncology drug SH-110. This proprietary product will have a significant benefit to patients suffering from brain cancer ultimately reducing treatment burden and providing a palatable age appropriate treatment. The clinical trial to support NDA filing will commence later this year.
The SH-111 filing is currently undergoing review by FDA. SH-111 is a life changing treatment that is often in shortage and the company looks forward to working closely with FDA to bring this much needed product to market in 2022.