Pharmaceutical News and Updates
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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…
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New GVP Guideline on Vaccines
The new Guideline on the Pharmacovigilance of Vaccines against infectious agents has been released for comments from Industry, healthcare professionals, patients’ organisations. The final release is planned for Q4 2013. We have summarised below, for…
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EMA Work Program for 2013
by, Simon Ruini 13 March 2013 The European Medicines Agency (EMA) has just released the work program for 2013. The executive director Guido Rasi stated that the Agency will pursue the following priority areas,…
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GVP Audit, Module IV
The final version of EMA’s Module IV, regarding Pharmacovigilance Audits, came into effect 13 December 2012. There were several relevant changes to the draft version and we have listed them below: IV.B.2. It is…
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Talent gap, a research from PWC
A talent gap in the scientific workforce has biopharmaceutical companies searching outside for fresh skills and alternate approaches to R&D staffing, according to PwC’s Health Research Institute (HRI) in a new report published today. New…
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R&D: The Widening Gap between Success and Failure
The Office of Health Economics (OHE) has released a new study examining drug development costs over the past 30 years. The study finds that out-of-pocket costs to bring a new medicine to market have increased…
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Good Pharmacovigilance Practice (GVP)
The new Pharmacovigilance Legislation (GVP modules) in Europe is an attempt to harmonise and rationalise a complex set of regulations, which are out of date and purpose. The main objective is to define clear roles…
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From Drug Manufacturers to value-added Providers
Countries have being implementing cost containment measures since at least 2000. What is ‘new’, since the ‘financial crisis’ of 2008, is the pace and the severity with which budget controls are applied. Politicians are influencing…