Tagged with Cell and Gene

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…

Spain In 2021, a hospital in Barcelona managed to get approval for the first European-developed CAR-T cell therapy. Aided by a little girl and her mother, a team of doctors at the Hospital Clinic Barcelona moved early to learn from the American physician that pioneered the treatments, did not take no…

USA When the FDA gave Novartis the historic green light for Kymriah – the first gene therapy approved in the United States – in 2017, the agency declared that it was “ushering in a new approach” to the treatment of cancer and other serious and life-threatening diseases. Today, more than 20…

Italy Gilead Sciences’ vice president and general manager for Italy, Valentino Confalone, outlines the company’s tumultuous pandemic journey in one of the first global epicentres; the role that Italy played in the early studies of remdesivir as a treatment against severe COVID-19 disease; how Gilead is working to eliminate viral Hepatitis…

Global Greg Reh leads Deloitte’s global life sciences sector which includes clients in biopharma, medtech, generics and distribution businesses, as well as non-profit patient advocacy organizations and regulatory agencies. He discusses talent acquisition and retention in global life sciences today, the challenges around data and AI uptake, and the future of…

Mexico David López García, Mexico country manager of global rare genetic therapy player Biomarin, outlines the challenging situation around patient access to orphan drugs in Mexico and the importance of building awareness of rare diseases.   The challenge for orphan drugs is the price. It is not always easy to explain…

Korea Cure Therapeutics is a startup developing gene and cell therapies in Korea. Its founder David Kim explains where his passion for regenerative therapies stems from, breaks down the main hurdles standing in the way of success and describes how his company’s business model focused on flexibility and development speed through…

Korea Woosok Lee, CEO of Kolon Pharma, Kolon Life Science and Kolon TissueGene, offers his insights into the potential of their blockbuster product Invossa which could exceed USD five billion of revenues in the USA following its approval. Mr Lee also clarifies Korea’s position within gene therapy R&D and explains Kolon’s…

Korea Dr BG Rhee, CEO of SCM Lifescience discusses their patented proprietary subfraction technology to extract high purity cell cultures, and the impact this will have on the efficacy, cell differentiation ability, and cost of stem cell treatments. Dr Rhee also provides his assessment of the regulatory framework for stem cells…

UK A spinout from the Roslin Institute that created Dolly the Sheep, Roslin CT is a cell and gene therapy CDMO, with a unique positioning in the field today. Its CEO, Janet Downie, presents the company’s expansion plans and talks about new areas worth pursuing as well as the advantages of…

UK Keith Thompson, CEO of the Cell & Gene Therapy Catapult, one of a number of Catapult institutions in the UK designed to help commercialize innovative research, discusses strategy, funding, international collaboration and Brexit.     Most likely, the UK is the best environment for putting forward trials that are properly…