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Clinical reports

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How to keep your name development on schedule after the recent EMA NRG announcement

Three key action points

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Most of the EU would like to host the EMA

Nineteen member states will compete to host the agency when it leaves the UK

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Amgen aspires to new Kyprolis label in the US and Europe

Appeals to regulators to add survival data to multiple myeloma drug's labelling

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Europe vs the US: New drug product approvals

As US approvals rates in the US drop,  the EU is not currently showing a similar trend

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UK signals desire for close post-Brexit relationship with EU

Health and business ministers outline areas where collaboration may continue

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EMA and FDA calls for innovative approaches for Gaucher disease medicines

The regulatory agencies also urge a similar method for all paediatric diseases

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Europe delays EMA relocation decision

Will resolve the issue in November, one month later than expected

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Shoring up the framework

European regulators add a measure of clarity to pharma’s uncertainty around Brexit

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European regulators mull use of… QR codes

EMA’s Heads of Medicines Agencies committee outlines packaging proposals

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Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

Panel recommends insulin Lispro Sanofi to treat diabetes

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EU starts investigation of Aspen’s cancer drug pricing

Amid reports of price increases of several hundred per cent

- PMLiVE

EMA develops framework for academia collaborations

Looks to develop the way it works with the academic community

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