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European Ombudsman

- PMLiVE

EMA to review safety of Ariad’s Iclusig

Product information will be updated to warn of blood clot risk

- PMLiVE

EMA on track with biosimilars guidance says industry

Updates expected to build confidence among healthcare professionals and patients

- PMLiVE

EMA publishes European drug shortage details

First public list contains details on Cerezyme, Fabrazyme, Increlex and Vistide

- PMLiVE

CHMP names France’s Pierre Demolis vice-chair

He is director of the oncology and haematology division at the ANSM

- PMLiVE

Novo Nordisk recalls insulin

Batches of prefilled NovoMix 30 pens found to have incorrect amount of diabetes treatment

- PMLiVE

EMA backs Lundbeck’s Brintellix in depression

Drug recommended for approval to treat major depressive episodes in adults

- PMLiVE

Leo Pharma plans to share trial data from 2014

"It is the right thing to do" says UK managing director

- PMLiVE

EMA defends position on patient-level data

Regulator claims pharma industry fears over transparency are unfounded

- PMLiVE

J&J files HIV combination in Europe

Seeks approval for fixed-dose tablet containing Prezista and Gilead’s cobicistat

- PMLiVE

Orexigen files obesity drug in EU

Company expects Contrave to show positive cardiovascular safety 

- PMLiVE

EU launches black triangle drug monitoring scheme

New pharmacovigilance symbol will be used by all drugs needing additional monitoring

- PMLiVE

AZ moves closer to EU approval for ovarian cancer drug

Olaparib on course to be first PARP inhibitor available for ovarian cancer

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