Interview with Hanna-Riikka Kärkkäinen Head of Quality and Regulatory Affairs at Aurealis Therapeutics | Professional career, AUP-16 PRIME designation, FDA Advice & more

What was the journey that took Hanna-Riikka Kärkkäinen to her current role as Head of Quality and Regulatory Affairs? What does having the PRIME designation for AUP-16 mean? What was the result of the FDA Advice that Aurealis had with respect of AUP-16? How are the preparations to take AUP-16 to the world moving forward? […]

Half of the Patients Successfully Recruited and Randomized in Aurealis Therapeutics DIAMEND AUP-16 Phase-2 Study

Zug, Switzerland and Kuopio, Finland, March 11, 2024. Aurealis Therapeutics, a Swiss-Nordic clinical-stage company developing scalable and low COGS multi-target cell and gene therapies, announced today the successful recruitment and randomization of half of the patients expected to participate in its DIAMEND AUP-16 Phase-2 clinical trial on Diabetic Foot Ulcers (DFUs). AUP-16 is Aurealis Therapeutics’ […]

Aurealis Therapeutics Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support and Accelerated Assessment of AUP-16 in Non-healing Diabetic Foot Ulcers

Priority medicines (PRIME) is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach […]