Hong Kong In March 2024, the Advanced Therapy Product Good Manufacturing Practice Centre (ATP GMP Centre) at the Chinese University of Hong Kong’s (CUHK) Institute of Biotechnology (HKIB) became the first university-led centre within the special administrative region to receive certification for cell and gene therapy manufacturing and a license as an…
Denmark Peter Halling, CEO of ALK, leads the century-old allergy immunotherapy innovator through a transformative phase focused on expanding patient access and innovation globally. In this interview, Halling discusses ALK’s Allergy+ growth strategy and response to rising allergy prevalence, unique “field to pharmacy” production model, and ambitions to balance strong European…
Global Radioligand therapy (RLT), a specialized type of radiopharmaceutical therapy (RPT) that targets markers on tumor cells, is becoming a cancer treatment game changer. With a first FDA approval for Novartis’ Pluvicto, RLT has proved its potential. But are current regulatory frameworks and healthcare systems prepared to integrate this less-than-typical therapy?…
Global 2023 may have been a breakthrough year for cell and gene therapies with the FDA approving a record of seven novel treatments, but 2024 did not fall behind in the number of greenlit therapies. With seven new approvals and three expanded indications, the cell and gene therapies authorized by the…
Global With a record number of recent approvals representing game-changing potential for conditions like sickle cell disease, a significant number of advanced therapies making progress in the clinic, and an uptick in investment, cell and gene therapies are set to continue making considerable headway in 2025. Yet their elevated price tag…
Switzerland Emanuele Ostuni, CEO of ARTBIO, delves into the company’s innovative approach to radioligand therapies, focusing on its potential to replace chemotherapy and provide more effective treatment options for patients. Ostuni emphasizes the company’s commitment to precision oncology, with a strong team spread across Switzerland, Norway, USA, and the UK. …
Europe This year’s European Society of Medical Oncology (ESMO) was the largest ever. Over 33,000 people attended ESMO Congress 2024 at Barcelona’s cavernous Fira Gran Via conference centre, where 5,000 abstracts were presented and 600 expert speakers took to the stage. The healthcare professionals and cancer drug developers in attendance were…
Hong Kong Derek Chang introduces some of the key therapeutic advancements Novartis has been able to introduce in Hong Kong, including cell therapy and siRNA therapies, and its ongoing focus on targeted radioligand therapies, which benefit from the territory’s robust legislative framework. Chang also touches on the importance of Hong Kong’s “1+”…
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…
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