Clinical Trial Authorisation

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. According to the plans, initial applications for the lowest-risk Phase III and IV trials will be processed by the MHRA within 14 days instead of the statutory 30 […]

BlueRock Therapeutics has been granted Fast Track designation by the US Food and Drug Administration (FDA) for DA01 for advanced Parkinson’s disease (PD). DA01, BlueRock’s pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase I study. “Receiving Fast Track Designation from the FDA is an important step, which will help us further […]

Moderna has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older. Stéphane Bancel, Chief Executive Officer of Moderna, said: “We look forward to working with the FDA […]

Avacta, the developer of Affimer biotherapeutics and reagents, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK for a Phase I study of its lead pre|CISION pro-drug, AVA6000 pro-doxorubicin. In AVA6000, doxorubicin has been modified with Avacta’s pre|CISION chemistry, which renders the modified […]