Pharmaceutical News and Updates
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Pay-for-delay settlements under scrutiny
Drug manufacturers urged to reconsider patent dispute strategies in response to ground-breaking EU and US rulings. On 19 June the EC published its first decision on “pay for delay” settlements, levying fines of €93 million on…
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EMA and US FDA outline first assessment of quality-by-design applications
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements…
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When do you need to update a Risk Management Plan?
There is no longer an automatic requirement to update RMPs on a fixed-time basis. The Agency and the national competent authorities (NCAs) in EU Member States are now adopting a risk-based approach to RMP…
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WHO highlights pharmaceutical issues for ageing conditions
For the first time, EU countries have more people over 65 years of age than under 15 years of age. Echoing the trend seen in Europe, much of the rest of the world, including…
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Marketing in more complex healthcare systems
By Simon Ruini, London Marketing strategies have evolved as a result of more complex healthcare systems. Payer’s restrictions, value based pricing, increased safety surveillance and ongoing regulatory support mandates a bird’s eye view strategy as…
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Medicines Patent Pool Pediatric ARV Licenses, an interesting way of moving forward on Patents and Access to Medicines
The Medicines Patent Pool (MPP) is an organisation designed to improve the health of people living in low- and middle-income countries. The Pool’s goal is to increase access to quality, safe, effective, more appropriate and affordable medicines,…
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Towards common EU pricing. European Medicines Agency and EUnetHTA review progress of their cooperation.
The European Medicines Agency (EMA) and EUnetHTA, the European network for Health Technology Assessment (HTA), met to review the progress of their cooperation in London on 14 May 2013. This was the sixth meeting since…
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Amendments to the pharmacovigilance legislation
Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the amendments to…
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Avandia new evidence to be evaluated next week in the U.S.
In 2010 the drug Avandia (rosiglitazone) was restricted in the US and banned in EU, after researchers found that patients were possibly subject to increased risk of heart problems after taking it. Today, Avandia…
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A Study from EAHC on the EU Pharmaceutical Market Outlook in the Next 5 Years
We are happy to publish the results of an EAHC sponsored study on the EU pharmaceutical market outlook for the next 5 years, as we believe it presents some interesting scenarios. Here are some…