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- PMLiVE

adverse events

- PMLiVE

EMA: more fee reductions for orphan drugs

Greater incentives introduced for larger companies

- PMLiVE

BMS/AZ’s diabetes drug among CHMP recommendations

Xigduo one of six new drugs backed in EU

- 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

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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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