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- PMLiVE

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Antibiotics among 7 new drugs backed by EMA

The Medicines Company’s Orbactiv and Cubist’s Sivextro set for European approval

- 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

Boehringer drug approved in EU for rare lung disease

Nintedanib is already available as cancer treatment

Shire Basingstoke

Shire signs deal to buy NPS for $5.2bn

Firm hopes to boost its presence in rare disease sector

- PMLiVE

EMA picks projects for adaptive licensing project

Begins discussions on how the model will be implemented in practice

- PMLiVE

Assessing drugs for ultra-rare conditions in the UK

Alexion’s Soliris has become the first drug to pass through NICE’s new highly specialised technology process

- 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

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