European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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Articles
Pharma within planetary boundaries
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
Turning the TIDE: oligonucleotide development trends
Discover what is driving the oligonucleotide therapeutics sector as scientists navigate challenges such as financing and success-to-market.
Psychedelic medicines: are they gaining traction in Europe?
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
ILAP: Improving access to innovative oncology treatments
With no new first-line treatment for de-differentiated liposarcoma in over forty years, Dr Christoph Zehendner, Medical Director of Boehringer Ingelheim UK and Ireland discusses the company’s ILAP designation of its investigational, innovative treatment.
Developing novel therapies for NASH
In this exclusive interview, Dr Hank Mansbach, Chief Medical Officer of 89bio discusses clinical development of FGF21 therapy to treat fatty liver disease.
ebook: Nanoparticle formulations: overcoming dissolution challenges
This ebook explores the potential of nanoparticle formulations for drug delivery, as well techniques to predict in vivo bioavailability of these dosage forms.
Parallel import of medicinal products: regulatory update
Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union.
Handling HPAPIs safely – what does it take?
Here, Veranova's Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).
Leading in Pharma: a woman’s pathway
Here, to mark International Women’s Day, Dr Ekaterina Malievskaia from COMPASS Pathways reveals her path to working in mental health and the pharma industry.
Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
Prioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
Computed tomography for in-depth investigation of freeze-dried products
In this article, Teresa Siegert and Henning Gieseler, discuss the benefits of applying computed tomography in the production of freeze-dried pharmaceutical products, as well as the hurdles that must be navigated to realise its potential.
New workflow for the analysis of mRNA therapeutics
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
NITROSAMINES: Where now?
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
