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- PMLiVE

CUP

- PMLiVE

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

UK pharma launches legal challenge to NICE plans

Applies for judicial review of budget impact test

EphMRA 2017 round up

We were delighted to present, exhibit and sponsor this year’s EphMRA Annual Conference in Amsterdam, Netherlands.

Research Partnership

- 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

FDA moves to tackle orphan designation backlog

Some 200 requests are awaiting review by the US regulator

- PMLiVE

Digital disruption in market access

Infinite possibilities

- 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

Rare diseases: meeting the challenge

Problems with regulating orphan drugs

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