Archive: 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…
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…
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.
ImmunOs Therapeutics Appoints Dr. Constanze Guenther as Senior Vice President, CMC and Technical Development
– Former Novartis Executive Director brings significant expertise in manufacturing, operations, and technical development
ImmunOs Therapeutics AG, a biopharmaceutical company leveraging its HLA-based technology platform to develop first-in-class therapeutics for the treatment of cancer and inflammatory diseases, today announced the appointment of Dr. Constanze Guenther as Senior Vice President, CMC and Technical Development.