Pharmaceutical News and Updates

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, focusing on HIV/AIDS. They do this by negotiating with patent holders to share their HIV medicines…

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 the start of their collaboration in 2010. The focus of this meeting was on how…

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 the 2010 pharmacovigilance legislation of the European Union (EU): temporary or permanent marketing cessation or suspension…

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 is a drug of last resort in many parts of the World for people with…

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 of the highlights: ‘One of the main drivers of pharmaceutical expenditure is the entrance of…

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 those of you who are less familiar with PV in Vaccines or Biologicals, some sections…