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Cuts in healthcare costs due to post-recession austerity programs mean favorable Health Technology Assessments (HTAs) are becoming crucial to the successful market launch of pharmaceuticals in Europe.

As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.

The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013.

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.

The UK National Institute for Health and Care Excellence’s (NICE) decision that relapsed non-small cell lung cancer patients should no longer have access to Roche’s cancer pill Tarceva (erlotinib) is a setback for lung cancer care in England and Wales.

It is nowadays fashionable to question everyone in authority, and there is no shortage of self-appointed watchdogs who aim to make sure that things that happen are happening as they should.

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Pharm Exec begins its 34th year with a feature on Russia's ambitious plans to build a homegrown biopharma business. Back in 1980, the biotech industry did not exst. Drugs were still classified as chemicals, developed from the random screening of many thoughts.