Tagged with cell

China Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

United Kingdom The recent FDA decision to investigate the serious risk of patients developing new cancers after treatment with CAR-T therapies may have created some bad press around cell and gene therapies, but AstraZeneca has continued to consolidate its ambitions in the area with the acquisition of China-based cell therapy biotech, Gracell…

United Kingdom Since its creation over 20 years ago, the National Institute for Health and Care Excellence (NICE), the Health Technology Assessment (HTA) body for England and Wales, has forged a solid reputation as one of the world’s foremost HTA authorities. Speaking at the recent FT Global Pharma and Biotech Summit, NICE…

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Global Dr Vivienne Marshall, senior director of the Center for Advanced Therapies at the South Texas Blood & Tissue Center, part of BioBridge Global, outlines some of the major barriers to wider adoption of cell and gene therapies: complexity, variability, and the lack of robust standards. Dr Marshall also highlights the…

Belgium Encircled by heavyweight life sciences powerhouses of the likes of Germany, France and Switzerland, plucky Belgium nonetheless continues to astonish and project considerable influence when it comes to its abilities to develop, manufacture and sell medicines.   Despite representing only a mid-size marketplace from an in-country commercial perspective, the comparatively…

UAE CSL Behring – which specalises in plasma-derived, and recombination therapeutic products – has undergone significant expansion in the Middle East and Africa (MEA) region in recent years under Hassan Herrou. He explains why building partnerships with the relevant authorities as well as patient associations is vital to fostering access in…

Global The Alliance for Regenerative Medicine (ARM) brands itself as the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. ARM’s latest sector snapshot details the cell and gene therapy approvals list for 2022, as well as the number of…

Belgium Perhaps to the surprise of many, Belgium is the world’s second-largest producer of vaccines, behind only the US, and – capitalising on its years of experience in the field – played a vital role in the development, production, and distribution of COVID-19 vaccines over the past three years. An ecosystem…

Belgium Back home in Belgium after a stellar stint in Big Pharma, Dr Paul Stoffels* is now looking to reshape the future of cancer care with the biotech he helped co-found in 1999, Galapagos. In an exclusive conversation with PharmaBoardroom, Dr Stoffels outlines his excitement about a new CAR-T delivery model that…

Belgium Univercells is a group of companies founded a decade ago based around the concept of revolutionizing the availability of biologics around the world through making essential medicines affordable to all, in both quality and price. CEO Hugues Bultot outlines the scale and scope of the organisation today, its fundraising and…