The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Clinical Trial Authorisation to a potential preventative therapy for Cytokine Release Syndrome (CRS). The TOPICAL trial will investigate Poolbeg Pharma’s therapy, POLB 001, in approximately 30 relapsed/refractory multiple myeloma patients receiving the approved bispecific antibody teclistamab. Previous research showed POLB 001, if approved,… Read More
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… Read More
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,… Read More
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… Read More
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… Read More
