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- PMLiVE

Sputnik V

- 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

- PMLiVE

Data transparency in Europe

Will 2015 usher in a new era?

- PMLiVE

EMA: Lack of evidence for Ebola treatments

Not enough data to draw conclusions on effectiveness of experimental drugs

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EC: Search for Rasi’s replacement could take six months

Commission tells PMLiVE process could still be impacted by the procedure's complexity

- PMLiVE

Novartis’ heart failure drug on EMA’s fast track

Candidate is the first cardiovascular drug to get accelerated review in the EU

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Orphan drugs in latest CHMP recommendations

EMA advisers back new products from Genzyme, Boehringer and others

- PMLiVE

EMA recommends two AbbVie treatments for hepatitis C

Exviera and Viekirax backed for use in Europe

- PMLiVE

EMA appoints Luc Vanheel as head of administration

He joins with immediate effect

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