Tagged with therapy

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…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…

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 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 Maria Fernanda Prado highlights some of the lessons drawn from her extensive experience in emerging markets which remain applicable in her current role as Janssen’s managing director for the Benelux region. Belgium, the home country of Dr Paul Janssen, continues to be a significant part of the company’s global operations,…

Hong Kong With the global market for cell and gene therapy (CGT) products set to skyrocket in the coming years, Hong Kong is looking to get in on the action with the opening of a new Advanced Therapy Products (ATP) Good Manufacturing Practice (GMP) Centre earlier this month.   Leveraging the city’s…

USA Astellas has steadily developed its immuno-oncology (IO) pipeline via both organic and inorganic means in recent years, with its early-phase IO projects now overseen by industry veteran Peter Sandor, the company’s SVP and IO Primary Focus Lead. Sandor explains the variety of exciting IO approaches in development at Astellas, how…

Singapore MSD is set to inject an additional USD 500 million into its existing Singapore manufacturing operations with two new facilities to produce vaccines and biologics. One of the new plants will turn out MSD’s immunotherapy for cancer and its human papillomavirus (HPV) vaccine for the Asia-Pacific region. The reason we…

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…

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…

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…