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clinical trial regulation

- PMLiVE

Market access improvements in Turkey

With 78 million inhabitants, a universal public health insurance scheme, regulations largely harmonised with EU rules and a growing economy, Turkey - the largest market in the Middle East, North...

- PMLiVE

Surviving Brexit

How UK biopharma must adapt to a changing landscape

- PMLiVE

Lilly closes on first approval for sarcoma drug Lartruvo

Orphan drug improved patient survival time by almost 12 months in phase II trial

- PMLiVE

Combatting EU drug shortages

New guidelines to be issued after EMA report

- PMLiVE

Newron back on track for Xadago approval in US

Italian firm is not required to conduct additional trials for its Parkinson’s disease drug

EFPIA director general Richard Bergström resigns

Will remain in the role until a successor has been selected

Brextinction

Evolution predicts tragic consequences from the UK's choice

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EU proposes reforms to make first-in-human trials safer

New guideline revision paper “takes into account lessons learnt” from fatal Bial trial

- PMLiVE

EU clears AZ’s FDA-rejected diabetes combination

Approval of two-drug therapy Qtern presents first-to-market advantage in Europe

Bristol-Myers Squibb (BMS) building

Opdivo moves closer to head and neck cancer approval

Possible US verdict by November for BMS’ ‘breakthrough’ SCCHN therapy

- PMLiVE

Celgene’s Revlimid cleared for aggressive lymphoma type in EU

Analysts anticipate sales of up to $10bn for the newly-expanded drug in coming years

- PMLiVE

EMA: ‘business as usual’ – for now – after Brexit

And says it will be up to remaining EU members to decide on its future location

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