News

Tuesday, 26. September 2023 | Filed under Company News

Dopavision Reports Successful Completion of Enrollment for MyopiaX-1 Trial

– MyopiaX-1 trial to generate first clinical evidence with MyopiaX®, a novel therapeutic approach to manage myopia progression

– First data readout expected in Q1/ 2024 with study completion planned for September 2024

Dopavision, a clinical-stage company developing innovative solutions for the management of myopia, today announced the successful completion of enrollment in its MyopiaX-1 trial (NCT04967287). MyopiaX-1 is a randomized, active-controlled trial to evaluate the safety, tolerability, and clinical outcomes of MyopiaX® in pediatric participants with myopia. Read more…

Monday, 25. September 2023 | Filed under Company News

Cellbox Solutions Submits Device Master File (DMF) to the U.S. FDA

— Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector

— Cellbox customers can now reference the DMF, simplifying and accelerating their regulatory approval process for cell therapy production processes involving the Cellbox Technology

Hamburg, Germany, September 25, 2023 – Cellbox Solutions GmbH, a leading provider of warm chain logistics solutions for the research, development and shipment of cell-based therapies and cellular diagnostics, today announced that is has successfully submitted a Device Master File (DMF) for its Cellbox Live Shipment Technology  to the U.S. Food and Drug Administration’s (FDA). Read more…

Tuesday, 19. September 2023 | Filed under Company News

1ST Biotherapeutics Announces Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate FB849 in Combination With KEYTRUDA® (pembrolizumab)

                    

1ST Biotherapeutics, Inc., a clinical-stage biotechnology company focused on the development of novel small molecule therapeutics in neurodegenerative diseases, immuno-oncology, and rare diseases, today announced a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA, to evaluate FB849 in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase I/II clinical trial for the treatment of patients with advanced solid tumors.

Read more…