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- PMLiVE

Clinical Trials Directive

- PMLiVE

EU and UK pharma leaders appeal directly to Brexit negotiators

EFPIA, ABPI and BIA warn Michel Barnier and David Davies an unorderly withdrawal could hit medicine supplies

- 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

- PMLiVE

EMA and FDA calls for innovative approaches for Gaucher disease medicines

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

- PMLiVE

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

Europe needs ‘sustainable data ecosystem’

Better use of data must be made if patients and healthcare systems are to benefit

- PMLiVE

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

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CHMP backs two rare disease therapies at April meeting

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

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