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- PMLiVE

etesevimab

- PMLiVE

BMS/AZ’s diabetes drug among CHMP recommendations

Xigduo one of six new drugs backed in EU

Biogen Idec building

Biogen Idec wins EU battle on Tecfidera exclusivity

Oral MS drug gains New Active Substance status

- PMLiVE

Ariad’s cancer drug to remain on EU market

But EMA restricts use of Iclusig due to blood clot risk

- PMLiVE

CHMP recommends Gilead’s sofosbuvir for hep C

Set to be first interferon-free treatment regime

EU flag

EMA drug data to address HTA needs

EU regulator agrees joint work plan with EUnetHTA

- PMLiVE

EMA warns of excessive caution by regulators

Agency says risk aversion could deny patients new treatments

- 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

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