Tag Archive for: clinical trials

Diversity and inclusion are important pillars of the healthcare industry, especially within the clinical research space. To ensure the best overall patient care, it is critical to have an appropriate representation of the populations being researched. Understanding why and how minority populations are underrepresented allows pharmaceutical sponsors and CROs to outline actionable steps to create more diverse and equitable trials.

The introduction of technology interoperability regulations and advancements in artificial intelligence, implementing technology tools can significantly reduce the burden at every level of organization operations. It can also improve the success rates of clinical trials and accelerate the development of new treatment options for the patients who need them. 

Last May, a 13-year-old girl was the world’s first patient to receive base-edited T cells for her incurable T cell leukemia. Since then, two more children have been treated and results were published in The New England Journal of Medicine on Wednesday.  

“There could be around 10 total regulatory decisions this year on cell and gene therapies, including up to five decisions on gene therapies for rare genetic diseases alone,” said Stephen Majors, director of public affairs at the Alliance for Regenerative Medicine.

In a wave of advanced technology and decentralized clinical trials, sponsors have turned to electronic tools such as electronic clinical outcome assessments (eCOAs) to capture patient reported outcomes data.

Astellas Pharma will license and further develop a gene therapy from Kate Therapeutics aimed at addressing XLMTM amid safety concerns about its own experimental XLMTM treatment.

Top-line results from a Phase IIa study showed that Glyscend Therapeutics’ lead candidate GLY-200 demonstrated promising safety and efficacy in patients with Type 2 diabetes, the company announced Wednesday.

U.S. drugmaker Pfizer Inc. said on Tuesday late-stage study data for its experimental hemophilia therapy showed superiority to the current standard of care treatment in reducing bleeding rates in patients.

The newly created role demonstrates commitment to improve diversity in clinical trials and commercialization across organization.

Viking Therapeutics Inc said on Tuesday its experimental drug met the main goal of a mid-stage trial to treat patients with a type of fatty liver disease, sending its shares about 6% higher in early trade.