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- PMLiVE

Clinical reports

- 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

EISAI

Eisai wins EU licence for kidney cancer drug Kisplyx

Approved as a second-line combination treatment for advanced RCC

- 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

- PMLiVE

Lundbeck challenge to EC pay-for-delay ruling fails

Court upholds €94m fine for paying off firms to delay launch of Celexa generics

- 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

Keytruda cleared in Europe for lung cancer

New second-line indication for Merck’s drug puts it in direct competition with BMS’ Opdivo

- 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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