European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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Articles
Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
Big potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about…
SFC-MS: advancements and applications in pharmaceutical quality control
Modern supercritical fluid chromatography systems coupled with mass spectrometry are empowering pharmaceutical quality control laboratories. Here, Hugues Jambo, Cédric Hubert, Éric Ziemons and Philippe Hubert from the Laboratory of Pharmaceutical Analytical Chemistry at the University of Liège discuss applications from impurity and nitrosamines detection to purity analysis.
Modifier gene therapy – clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
Developing the EU’s first intestinal microbiota-based biologic
In this final installment of EPR's Microbiome therapeutics: microscope to medicine, Dr Olaia Aurtenetxe, Head of Clinical Research at Mikrobiomik, reveals study data demonstrating why MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for Clostridioides difficile infections (CDI), potentially…
Delivering long-acting oral treatments
In this interview, Kyle Haraldsen, Chief Technology Officer of Lyndra Therapeutics, explores how the drug delivery landscape is evolving to increase focus on patient centricity and sustainability through development of long-acting, oral-delivery technologies.
Regulation and legislation in the era of automation and digitalisation
Experts at IP firm Finnegan discuss if the pharmaceutical industry is ready for the innovation and technologies that digitalisation and automation will bring, and whether these advances are a threat or ally to intellectual property rights in the sector.
Advancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
Fresh or frozen? Navigating the cryopreservation dilemma for CGT
Cell and gene therapy development grapples with a paradox: fresh starting material is often equated with higher-quality drug products, but cryopreservation is crucial for scale-up. In fact, every approved autologous cell-based therapy relies on freezing cells. Reconciling these truths can be key for the success of any commercial therapy based on…
Pioneering AAV gene therapy for Krabbe disease
Dr Maria Escolar, Chief Medical Officer, Forge Biologics, explores the advantages of the company’s novel AAV gene therapy for Krabbe disease, which could help to overcome some of the immune and safety challenges the gene therapy sector is facing.
Pharma Horizons: Cell and Gene Therapy
This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
Harnessing small molecules to treat chronic inflammatory diseases
Dr Sheldon Sloan, MBE, Chief Medical Officer, Abivax, shares why the company’s microRNA small molecule treatment could provide long-term efficacy for ulcerative colitis patients, as well as the outlook for using small molecule-based drugs in autoimmune and chronic diseases.
Progressing personalised cell therapies in oncology
Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine discusses the major benefits and current challenges of CAR-T cell therapies, as well as the potential of the company’s novel BCMA-targeted treatment for multiple myeloma.
ICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
