AstraZeneca settles £505 million tax dispute with UK

AstraZeneca has agreed to pay the UK government £505 million to settle a long-running and complex dispute with the tax authorities1. At the heart of the dispute is the issue of transfer pricing, an accounting method that allows.....

 
UK consultation shows support for patient information plans in EU

The majority of respondents to a recent UK government consultation agree with the European Commission's proposal to allow the pharmaceutical industry to provide patients with non-promotional information on prescription medicines1......

 
EU and US strengthen ties on risk management and paediatrics

A progress report released jointly by the European Commission, the European Medicines Agency and the US Food and Drug Administration on last year’s “Transatlantic Administrative Simplification Action Plan” has identified.....

 
EMEA ups approval application forecast as generic filings rise

The European Medicines Agency has had to revise its forecasts for drug approval applications submitted via the centralised procedure this year after generic filings outstripped expectations in the first half.For the.....

 
NME postmarketing safety reviews are labour-intensive, US FDA finds

A US Food and Drug Administration pilot programme that reviewed the postmarketing safety of five new molecular entities identified a total of 22 safety issues for follow-up1. The project took more than 1,000 staff hours but the.....

 

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