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

April 18, 2024

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...

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

March 11, 2024

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...

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

February 27, 2024

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...

Interview with Haritha Samaranayake CMO of Aurealis Therapeutics | Professional journey, AUP-16 clinical trials in DFU & development plans for oncology

January 31, 2024

Watch full interview on YouTube What was the journey that took Haritha Samaranayake to his current role as CMO? What are the current advances in the clinical trials of Diabetic...

Aurealis Therapeutics Partner Xbiome Receives IND Approval from China’s National Medical Products Administration for the Phase 2 Study with AUP-16 in Diabetic Foot Ulcers

November 29, 2023

Xbiome announced that its Phase 2 study with AUP-16 (AUP1602-C) in diabetic foot ulcer has officially obtained IND approval from the National Medical Products Administration (NMPA) and the study can...

AUP-16: More cost-effective than the current Standard Of Care at healing Diabetic Foot Ulcers revealed at ISPOR Europe 2023

November 24, 2023

Aurealis Therapeutics, a Swiss-Finnish clinical-stage synthetic biology company developing bacteria-based multi-target cell and gene therapies for chronic wounds and cancer, participated in ISPOR Europe Health Economics and Market Access conference...

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