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- PMLiVE

Clinical Trials Directive

- PMLiVE

Surviving Brexit

How UK biopharma must adapt to a changing landscape

- PMLiVE

AZ withdraws EU filing for ovarian cancer drug cediranib

Maintains cediranib’s value as a combination therapy despite EMA information request

- PMLiVE

EMA’s head of international affairs steps down

Emer Cooke will take up new post at the WHO in November

- 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

- PMLiVE

Patient reporting rises after EU pharmacovigilance reforms

Safety issues detected more quickly with increased patient participation

- PMLiVE

Germany’s IQWIG ‘perplexed’ by EMA’s adaptive pathways plan

Reliance on real-world evidence questioned

- PMLiVE

EMA says adaptive pathways programme still needs refinement

Scheme aims to accelerate patient access to new drugs

- PMLiVE

EMA suspends generic drugs on data integrity concerns

Reports by FDA and WHO find evidence of data manipulation by Semler Research Centre

- PMLiVE

HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

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