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Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) gives her take on the industry response to the pandemic; highlighting the benefits of focused effort and what can be achieved through unified collaboration.
The COVID-19 pandemic spotlighted drug repurposing as a key strategy to support traditional novel chemical entity development; yet repurposing is just one example of how off-patent molecules can be further developed to provide patients with more treatment options. Here, Arun Narayan, Chairman of the Value Added Medicines Sector Group at…
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.
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.
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.
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…
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.
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.
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…
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.
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…
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.
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.
The EMA has recommended granting a marketing authorisation in the EU for Lamzede a long-term enzyme replacement therapy for alpha-mannosidosis...
