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- PMLiVE

vortioxetine

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Jinarc backed for European approval in rare kidney disease

Positive opinion for Otsuka comes just before rare disease awareness day

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EMA defends Humira redaction policy from transparency criticism

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

- PMLiVE

ViiV maintains top spot in reputation survey

But former top-ranked Gilead slides down in PatientView poll of patient groups

Gathering pace: adaptive pathways

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

- PMLiVE

Abraxane on course for lung cancer indication in EU

CHMP backs news indication for Celgene drug

- PMLiVE

Indian generics firm GVK set to be hit with European sales ban

EU regulator raises concerns on conduct of drug studies in India

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Antibiotics among 7 new drugs backed by EMA

The Medicines Company’s Orbactiv and Cubist’s Sivextro set for European approval

- PMLiVE

AZ files gout drug lesinurad in Europe

Acquired drug as part of its takeover of Ardea Biosciences in 2012

- PMLiVE

Regulators to improve cooperation on generic drugs

EMA to spearhead information sharing initiative

- PMLiVE

EMA picks projects for adaptive licensing project

Begins discussions on how the model will be implemented in practice

- PMLiVE

Orexigen’s obesity pill Mysimba set for European approval

But sales of the treatment are only predicted to reach $200m by 2016

- PMLiVE

‘Major step forward’ as EMA recommends first stem cell therapy

But wants more clinical trial data to shore up orphan drug's marketing licence

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