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Dovato

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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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ViiV files two-drug HIV maintenance regimen

SWORD studies show treatment could maintain viral suppression

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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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EMA develops framework for academia collaborations

Looks to develop the way it works with the academic community

Shire Basingstoke

Shire finally bags EU approval for rare disease drug Natpar

Becomes first licenced treatment for hypoparathyroidism in Europe

EU flag

CHMP backs two rare disease therapies at April meeting

Biogen's Spinraza and BioMarin's Brineura near EU approval

EMA establishes big data taskforce

Will explore how research and medicines development can be supported

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