cell therapy

As 2024 drew to a close, the cell and gene therapy sector has witnessed a string of recent approvals and some positive clinical trial data such as Mesoblast’s Ryoncil receiving FDA authorization for pediatric graft-versus-host disease in December, Adaptimmune’s Tecelra gaining approval for synovial sarcoma in August, and the landmark clearance of Casgevy (Exagamglogene Autotemcel)…

The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” This 40-page document, while not legally binding, offers insights into best practices for common questions received by the Office of Therapeutic Products (OTP). While each question is answered in brief, the…

Immunotherapies, including cellular immunotherapies, have dramatically impacted the treatment of cancer. Recent advances in the field, such as autologous (patient-derived) chimeric antigen receptor (CAR)-T cell therapies, have yielded remarkable results in relatively rare blood-based cancers. These results have driven an explosion in the research and development of different cellular products, including both autologous and allogeneic…

In an exclusive interview with Drug Discovery & Development, Astellas Pharma CEO Naoki Okamura and Chief Scientific Officer Yoshitsugu (Yoshi) Shitaka shared details about its new $90 million, 154,000-square-foot biotech facility in South San Francisco. The new Astellas facility will serve as a central hub for Astellas’ Bay Area employees and be pivotal for the…

Oncology may continue be one of the hottest sectors across the pharma sector, but other therapeutic areas are catching up in terms of innovation and investment. While oncology and hematology jointly accounted for about one-third of the new FDA approvals in 2023, investors are increasingly betting on precision medicine, advanced drug delivery systems and the use of…

As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other…

Less than a week after announcing that it has secured $255 million in Series C funding, South San Francisco-based startup Cellares has revealed that Bristol Myers Squibb has joined its Technology Adoption Partnership (TAP) program. To date, the company has raised more than $355 million in total financing. As part of the TAP program, Bristol…

Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But…

In recent years, the cell and gene therapy market has grown at a rapid clip. The momentum is likely to continue. According to Vision Research Reports, the global cell and gene therapy market size could hit around $42.56 billion by 2030, growing at a CAGR of 39% from 2022 to 2030. The burgeoning demand in…

The startup Cellares has a mission to enable industrial-scale cell therapy manufacturing with its Cell Shuttle, which it dubs a “factory in a box.” The germ for the idea traces back to market research that South San Francisco, California-based Cellares co-founder and CEO Fabian Gerlinghaus focused on in a prior role. While attending industry conferences,…

The cell therapy industry is in the early stages of growth and development, with only a few having secured regulatory approval. This approval comes with regulatory requirements that ensure safety, including patient outcomes data collection for up to 15 years post-infusion. While daunting, the strings attached to these first-generation therapy approvals help understand safety and…