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24 December 2014

The Russian parliament has approved a number of significant changes to the country's pharmaceutical legislation, including a new legal status of "marketing authorization holder", shorter new drug approval timelines, and a reduction in some clinical ...

24 December 2014

Following the signing of an association agreement and a ?Deep and Comprehensive Free Trade Area (DCFTA)?agreement between the EU and the Republic of Moldova on 27 June 2014, the south east European candidate country for EU membership has moved ...

24 December 2014

The European Medicines Agency's adaptive pathways pilot project seems to be gaining momentum. The project has now moved into its next phase, with six candidate drugs chosen to go forward to the more in-depth stage II meetings involving all ...

22 December 2014

At least someone has managed to secure an increase in their spending power for the coming year, despite the straitened economic times. The European Medicines Agency's budget for 2015 has been set at just over ?302m, up by 7% over the 2014 figure of ...

24 December 2014

The Russian parliament has approved a number of significant changes to the country's pharmaceutical legislation, including a new legal status of "marketing authorization holder", shorter new drug approval timelines, and a reduction in some clinical ...

24 December 2014

Following the signing of an association agreement and a ?Deep and Comprehensive Free Trade Area (DCFTA)?agreement between the EU and the Republic of Moldova on 27 June 2014, the south east European candidate country for EU membership has moved ...

24 December 2014

The European Medicines Agency's adaptive pathways pilot project seems to be gaining momentum. The project has now moved into its next phase, with six candidate drugs chosen to go forward to the more in-depth stage II meetings involving all ...

22 December 2014

At least someone has managed to secure an increase in their spending power for the coming year, despite the straitened economic times. The European Medicines Agency's budget for 2015 has been set at just over ?302m, up by 7% over the 2014 figure of ...

24 December 2014

The Russian parliament has approved a number of significant changes to the country's pharmaceutical legislation, including a new legal status of "marketing authorization holder", shorter new drug approval timelines, and a reduction in some clinical ...

24 December 2014

Following the signing of an association agreement and a ?Deep and Comprehensive Free Trade Area (DCFTA)?agreement between the EU and the Republic of Moldova on 27 June 2014, the south east European candidate country for EU membership has moved ...

24 December 2014

The European Medicines Agency's adaptive pathways pilot project seems to be gaining momentum. The project has now moved into its next phase, with six candidate drugs chosen to go forward to the more in-depth stage II meetings involving all ...

22 December 2014

At least someone has managed to secure an increase in their spending power for the coming year, despite the straitened economic times. The European Medicines Agency's budget for 2015 has been set at just over ?302m, up by 7% over the 2014 figure of ...

22 December 2014

At least someone has managed to secure an increase in their spending power for the coming year, despite the straitened economic times. The European Medicines Agency's budget for 2015 has been set at just over ?302m, up by 7% over the 2014 figure of ...

11 December 2014

The European Generic medicines Association (EGA) has decided to join the European Stakeholders' Model (ESM), a product verification system set up by industry and distributor bodies to tackle the trade in falsified medicines, despite its initial ...

10 December 2014

The German regulatory agency BfARM has suspended 80 generic drugs whose marketing authorizations relied on bioequivalence (BE) tests conducted by the Indian CRO GVK Biosciences 1 . GVK Biosciences' procedures have been called into doubt following a ...

08 December 2014

Roche and Novartis say they will continue to fight against the fine imposed on them earlier this year for allegedly colluding to exclude Roche's Avastin from the ophthalmology market in favor of Novartis's much more expensive Lucentis, despite ...

19 December 2014

In a decision that will be welcomed by the biotechnology industry, the Court of Justice of the EU has ruled that a parthenote - an unfertilized human ovum stimulated to grow by parthenogenesis - is not capable of developing into a human being and so ...

16 December 2014

The US Patent & Trademark Office has revised the guidance it issued in March that was aimed at addressing two Supreme Court rulings that rocked the life sciences sectors but which patent lawyers and biopharmaceutical firms said had shortcomings 1 ,2 ...

11 December 2014

The companies involved in making the three lead Ebola vaccines have gained liability protection in the US by a declaration from the Obama administration acting under the Public Readiness and Emergency Preparedness (PREP) Act of 2005 1 . The vaccines ...

 
11 December 2014
Ashley Yeo
As medical device regulatory systems - and users' understanding of them - have matured, so has the relationship between the regulators and the regulated. The entrenched 'us and them' positioning that might once have held sway has over time given way ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
23 December 2014
There has been a largely negative response from the medtech industry to unannounced audits by ...
22 December 2014
Against a backdrop of reforms designed to modernise the Russian healthcare system, the ongoing ...
22 December 2014
The Court of Justice of the EU has been asked to rule on whether it is correct to use the date of ...
 
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28 August 2013
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05 July 2013
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A candid look at the European drug regulatory network from Jytte Lyngvig, CEO of the Danish Medicines Agency 2000-2012
18 January 2013
 
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