Pharmaceutical News and Updates

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…

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, in an order of relevance that he has not assigned, but that Pharma Design interprets…

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 no longer stipulated that the risk assessment for the strategic, tactical and operational planning should…

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 R&D organizational models based on partnerships, alliances and even crowd sourcing are changing talent needs,…