Diabetes and obesity: treatment and trials update
European Pharmaceutical Review reports on some of the latest developments in treatments for type 2 diabetes and obesity.
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Articles
EMA’s new guide to implementing IDMP data standards triggers the countdown to change
The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response…
EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
COVID’s impact on cancer therapeutics: clinical trial and treatment disruptions
In this article, European Pharmaceutical Review’s Hannah Balfour discusses how COVID-19 has impacted the pharma industry with regard to cancer clinical trial and treatment disruptions.
Boom times for pharma M&A
Global mergers and acquisitions (M&A) activity last year was expected to decline from 2019 levels, mainly due to the COVID-19 pandemic and resulting uncertainty around the global economy, trade tensions between the US and China, and the presidential election in the US. However, James Baillieu from Bird & Bird reveals…
New regulatory landscape for biosimilars in the UK and EU post Brexit transition period
As the UK enters new territory following its departure from the EU, legal experts Marie Manley and Chris Boyle from Sidley Austin explore the resultant consequences for biopharma companies and the regulatory opportunities that lie ahead.
The current and future landscape of HIV treatments and vaccines
Dr Caroline Forkin from ICON discusses the current status of HIV treatments and potential for researchers to develop a vaccine.
Established and new mass spectrometry applications to drug discovery and development
Mass spectrometry has numerous applications in pharmaceutical research, from initial discovery through to characterisation and quality control. In this article, Dr Ioannis Papayannopoulos details the role of mass spectrometry in pharma R&D by highlighting established and novel applications of the technique in drug discovery and development.
Effect of moisture variation on the robustness of NIR spectroscopy-based calibration models
NIR spectroscopy is well-known for its sensitivity to water, which can be useful for detecting water variation in the sample matrix. However, for many other applications, water intake of the samples may be an issue and must be closely monitored to gauge the predictive performance of calibration models. This article…
Biosimilar uptake: a clinician’s perspective
To ensure that clinicians buy into biosimilars, it is important that they understand how products are analysed and compared to the originator molecules. Dr Fraser Cummings and Jonathan Sweeting discussed this issue at a recent virtual roundtable event, where they highlighted the complexities of biosimilar development pathways and approval processes. Here, Nikki Withers shares the…
Manufacturing of CAR T-cell therapies: an overview
The emergence of CAR T-cell therapies has ignited a revolution in the field of cancer treatments. While existing products show outstanding curative capability, they are hampered by significant clinical and commercial challenges, many of which stem from their manufacturing process. Maciej Nakoniecznik discusses how a combination of biological and technological advances…
Sourcing of active pharmaceutical ingredients
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
Promising biocompatible and biodegradable drug nanocarriers for cancer treatment and bone defect repair
Drug nanocarriers based on calcium phosphates and calcium silicates have attracted much interest in recent years owing to their excellent biocompatibility and biodegradability, high drug loading capacity, sustained and targeted drug delivery and promising applications in cancer therapy and bone defect repair. However, the research on drug-carrier interactions is a…
The importance of disaccharide excipients in biologics
Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…
Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, discover how biological and technological advances could enhance the clinical capabilities of CAR T-cell therapies and explore why clinicians need to be better educated about the development and licencing of biosimilars.
