FDA issues draft guidance for implementing decentralized clinical trials The U.S. Food and Drug Administration (FDA) on Tuesday said that it is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.Read More
Specialized printer may help vaccines reach more people Researchers have developed a specialized printer to generate vaccine-filled microneedle skin patches that can be stored long-term without refrigeration. Their research, published Monday in Nature Biotechnology, may eventually bring more vaccines to more people.Read More
Emergency brake keeps bladder cells from turning cancerous Fred Hutchinson Cancer Center scientists discovered an emergency brake that bladder cells use to ward off tumors even when cancer-promoting genes are turned on. In a study published April 20 in Cancer Cell, the scientists halted human bladder tumor growth in mice, suggesting the brake could be a target for future bladder cancer therapies.Read More
FDA approves cell therapy treatment for transplantation in blood cancer patients The U.S. Food and Drug Administration (FDA) on Monday approved the product Omisirge, a cell therapy treatment, for transplantation in blood cancer patients. The phase III trial results, published October 21, 2021, in the journal Blood, found the efficacy of Omisirge transplantation superior to standard umbilical cord blood transplantation.Read More
Researchers find new target for drug-resistant ovarian cancer Researchers working in a preclinical study have verified a new target for recurrent drug-resistant ovarian cancer and provided data to support a treatment approach now in clinical trials. The findings were presented on Sunday, during the American Association for Cancer Research (AACR) 2023 annual meeting.Read More