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- PMLiVE

Clinical Trials Directive

- PMLiVE

WHO calls for publication of previously unreported studies

Organisation claims results from clinical trials should be reported within 12 months

EISAI

Eisai’s thyroid cancer drug Lenvima nears EU approval

Positive recommendation by the CHMP could see the orphan drug used in Europe within three months

- PMLiVE

EMA elects Dr Christa Wirthumer-Hoche new vice chair

Head of the Austrian regulator succeeds Prof DrWalter Schwerdtfeger

- PMLiVE

SEC calls for greater disclosure from pharma

Claims companies are leaving themselves open to enforcement action

- PMLiVE

German drug cost containment system ‘aids data transparency’

New study by IQWiG suggests similar rules should be rolled out across Europe

EU flag

New cancer meds and drug extensions top CHMP recommendations

Drugs for rare disease, oncology and diabetes top regulator’s endorsements

Does ‘trust leadership’ feature in your strategy?

Pharma companies wanting to be more patient-focused will need to develop their people skills

Sanofi reception

Sanofi’s Lantus follow-up nears European approval

CHMP backing for Toujeo follows hot on the heels of its US approval by the FDA

EU flag

Jinarc backed for European approval in rare kidney disease

Positive opinion for Otsuka comes just before rare disease awareness day

EU flag

EMA defends Humira redaction policy from transparency criticism

Regulator says spirit of trial transparency intact after its handling of AbbVie reports

- PMLiVE

Astellas joins trial data sharing website

Joins Bayer, Boehringer, GSK, Lilly, Novartis, Roche and more

Gathering pace: adaptive pathways

EMA looks at how the model could work in practice and picks first drugs for its pilot project

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