Non-profit organisations the EspeRare Foundation, based in Switzerland, and US-based n-Lorem Foundation on Wednesday announced a strategic collaboration to expand access in Europe to n-Lorem's antisense oligonucleotide (ASO) therapies for patients with rare genetic diseases.
The collaboration aims to address the regulatory, operational, and diagnostic barriers that limit access to personalised genetic medicines outside the United States. The partnership will initially focus on pursuing treatment of a small number of nano-rare patients in Switzerland, with the goal of establishing a scalable model to support subsequent expansion across the European Union.
EspeRare will work with n-Lorem to support the identification of European patients who may benefit from n-Lorem's individualised ASO therapies that are already being used to treat nano-rare patients safely under FDA authorisation and to help enable the regulatory and clinical pathways required for treatment within Swiss and European academic medical centres.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval