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- PMLiVE

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UK Life Sciences Strategy - one year on

EMA starts firming up its stance on personalised medicines

But draft guidelines won't be ready much before 2019

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Shoring up the framework

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

- PMLiVE

European regulators mull use of… QR codes

EMA’s Heads of Medicines Agencies committee outlines packaging proposals

- PMLiVE

Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

Panel recommends insulin Lispro Sanofi to treat diabetes

- PMLiVE

EMA develops framework for academia collaborations

Looks to develop the way it works with the academic community

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