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Taking cell and gene therapies from idea to commercialisation
David Vincent, Process Development Lead at eXmoor Pharma, details some of the critical steps that form the manufacturing strategy for providers of cell and gene therapies.
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European Union (EU)
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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Supply of biosimilars and generics with Adrian van den Hoven, Medicines for Europe
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
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Navigating pharmacovigilance complexity in the US and EU: notes for biotechs
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
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EU regulators release medicine demand forecasting guidance for future crises
The new recommendations, developed in the context of the COVID-19 pandemic, are designed to help countries and other stakeholders forecast demand of medicines in future pandemics.
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Could GDPR be impeding the global COVID-19 pandemic response?
Jasper Bovenberg and colleagues argue that the General Data Protection Regulation (GDPR) and associated guidelines has frustrated COVID-19 research, potentially harming global pandemic response efforts.
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How to start up an ATMP clinical trial
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…
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Further billions pledged to ensure equitable access to COVID-19 treatments
The European Investment Bank (EIB), in partnership with the European Commission (EC), have pledged an additional €4.9 billion for use in the global coronavirus response funds.
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EU MDR: best practices for bringing enterprise labelling under control
Faced with the looming deadline for compliance of May 2020, many medical device companies still haven’t fully grasped the impact of the new EU Medical Device Regulations (MDR) across all their product labelling. The requirements also affect what goes on Information-for-Use (IFU) leaflets and electronic equivalents. Here, Graham Francis offers…
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Millions to be invested to prevent drug shortages for no-deal Brexit
A fund of almost £450 million has been announced by the UK Government to mitigate drug shortages in the event of a no-deal Brexit.
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EU releases guidance for medicine shortages
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.
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Enzyme replacement therapy to treat alpha-mannosidosis
The EMA has recommended granting a marketing authorisation in the EU for Lamzede a long-term enzyme replacement therapy for alpha-mannosidosis...
