Tagged with cell

Korea Founder and CEO of GeneMedicine, Dr Chae-Ok Yun, explains how the company, specialised in oncolytic virus development, has progressed since we last interviewed her two years ago, with one of its candidates getting close to phase II clinical trials and the construction of a new manufacturing facility that will enable…

Brazil The latest from Brazilian Pharma, including the approval of home grown cannabis for medical use, Cellera Farma’s partnership with Ferring, a considerable increase in demand for oncology drugs, and a dire diabetes prediction.   Brazil court approves home grown cannabis for medical use (ABC News) A top court in Brazil…

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…

China Due in part to an increasingly encouraging regulatory environment, China continues to strive for progress in cell and gene therapies (CGT). In fact, according to a 2021 Nature study, CAR T-cell therapy clinical trials in China have accounted for over 50% of registered CGT studies worldwide. Currently, over 200 CAR-T…

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…

Spain Ignacio Vega, CEO of Cardiva and Cardivais, a Spanish medtech producer and distributor, explains how, as a manufacturer of PPE, the company had to reconfigure its production operations to supply the Spanish and European markets during the COVID-19 pandemic. After commenting on the company’s presence in Spain, Italy, Portugal and…

Europe In an extensive recent PharmaBoardroom conversation, EMA Head of Advanced Therapies Ana-Hidalgo-Simon highlighted some of the most important trends around advanced therapy regulation in Europe. Hidalgo-Simon touched on why moderate growth in regulatory applications is a positive development for the EMA, how patient insights are being better incorporated into the…

Europe Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.   [Advanced] therapies are complex, difficult, and have a…

Korea Two decades ago, South Korean company Celltrion embarked on a quest to find the necessary resources to produce biopharmaceuticals. It took five years for their manufacturing plant to receive GMP certification from the US FDA in 2007 and another one to launch an initial public offering; an ascent that, while…

Spain Dr Manel Juan is part of the team behind the development of the first European CAR-T-cell therapy to treat multiple myeloma, the second most common type of blood cancer. As head of immunology at the Hospital Clinic Barcelona, he walks us through his personal journey with the project, the challenges…

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 As complex cutting-edge therapies come online, industry sponsors are increasingly looking to engage with patients, caregivers, and advocacy groups earlier and more broadly in the drug development process to better understand their needs. However, as the below insights from four of Novartis Oncology’s patient engagement leads show, successfully integrating patient…