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- PMLiVE

BMS/AZ’s diabetes drug among CHMP recommendations

Xigduo one of six new drugs backed in EU

- PMLiVE

EMA to review safety of Ariad’s Iclusig

Product information will be updated to warn of blood clot risk

- PMLiVE

EMA publishes European drug shortage details

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

- PMLiVE

Orphan status for Stem Cell’s leukaemia drug

Tigecycline wins FDA rare disease designation

- PMLiVE

FDA creates drug shortage plan

Manufacturers required to give early notice of potential shortfall of important medicines

- PMLiVE

FDA sets up rare disease research fund

Will invest $14m across 15 orphan drug projects

Orphan drugs: the early access regulatory environment

Despite considerable variation to the rules for unlicensed orphan drugs, there are some clear first steps for a global access programme

- PMLiVE

Lundbeck and Otsuka take Alzheimer’s drug into phase III

Lu AE58054 affects levels of serotonin in the brain

- PMLiVE

Boehringer shuts Ben Venue unit

About 1,100 jobs expected to be lost at troubled manufacturing site

- PMLiVE

EMA backs drugs from Novo, Otsuka, AZ, Janssen, GSK

Nine new branded medicines recommended for use in Europe

- PMLiVE

Otsuka to buy cancer biopharma Astex

Takes control of company behind Dacogen in $886m deal

- PMLiVE

J&J files rare blood disorder drug siltuximab in US and EU

Orphan drug to be assessed for use in the treatment of multicentric Castleman disease

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