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Over a year since the EU FMD came into force, false alerts remain a problem preventing the realisation of the full benefits of the directive. Grant Courtney examines the reasons behind these alerts occurring and looks at the action stakeholders must now take.
This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
New data models need to be built rapidly to respond to the COVID-19 pandemic. Matt Jones explains how to do it.
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
Dr Madhav Durbha explains the importance of implementing and ensuring stable supply chains to deliver potential COVID-19 vaccines.
The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
In an industry faced with numerous regulatory hurdles, the end-user experience can often be neglected. Nikki Withers spoke to two packaging design experts who discuss their approach to pharmaceutical packaging and why they always have the end user at the forefront of their minds.
Many pharmaceutical companies have complicated supply chains that are inefficient and ill-equipped to deal with current demands. This article explores how digitalising the healthcare supply chain can address the pharmaceutical sector's increasing financial-, capacity- and waste-related strains associated with our ageing population and the soaring costs of new treatments.
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
Repurposing existing drugs can be attractive as the process is often less risky, more cost effective and can be undertaken in less time. This article discusses the logic behind drug repurposing and the approaches that are currently being explored.
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
Since making its debut in the pharmaceutical setting, the range of applications for which Raman microscopy imaging has been used continues to grow. Here, Harald Fischer, Damon Strom, Miriam Boehmler, Eleni Kallis and Thomas Dieing demonstrate the versatility of confocal Raman imaging by exploring a variety of real-world applications.
As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.
