News

Prescribing of generic PPIs and statins in Scotland

Published on 2012/02/24

In Scotland, a series of measures have been introduced since 2000 in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins. Some of the measures introduced...

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Commission urges Greece to make parallel trade fair

Published on 2012/02/24

The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’. The Commission is requesting that Greece amends ...

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FDA finally issues draft biosimilar guidance

Published on 2012/02/17

The long-awaited guidance for biosimilars in the US has finally arrived. FDA announced on 10 February 2012 that it had issued three draft guidance documents on biosimilar product development to assist...

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EMA risk management plans may increase prescriber confidence in biosimilars

Published on 2012/02/10

In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase prescr...

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EMA a step closer to implementing new pharmacovigilance rules

Published on 2012/02/10

In an attempt to enable better protection of public health, new pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. It is now the job of EMA to ...

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Volume and sales of drugs on the shortages list in the US

Published on 2012/02/10

Despite record numbers of drug shortages being reported in the US, on the whole, over the past five years the supply of these drugs to healthcare providers–hospitals, clinics, pharmacies–has incre...

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Registration of biosimilars in Europe and the US

Published on 2012/02/10

Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process w...

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