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- PMLiVE

Increlex

- PMLiVE

Lilly closes on first approval for sarcoma drug Lartruvo

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

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Combatting EU drug shortages

New guidelines to be issued after EMA report

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Newron back on track for Xadago approval in US

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

- 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

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

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

- PMLiVE

Gilead’s Zydelig passes EMA safety review

Risk of ‘serious infections’ outweighed by cancer drug’s benefits

- 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

- PMLiVE

Ypsomed’s touch screen insulin pump for Novo Nordisk approved by EMA

mylife YpsoPump given green light for use with pump cartridge NovoRapid PumpCart

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