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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...
