European Medicines Agency Accepts Application Seeking New Indication For Prevenar 13 For Prevention Of Pneumococcal Pneumonia In Adults

August 7th, 2014 -Application Includes Data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) Pfizer Inc. (NYSE:PFE) announced today that the European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in …

GSK announces EU regulatory submission for malaria vaccine candidate RTS,S

July 24, 2014 GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a …

Gardasil: CHMP Grants Positive Opinion for New Indication, for the Prevention of Anal Cancers and Anal Precancerous Lesions, in the European Union

European Committee for Medicinal Products for Human Use evaluated positively a new indication for the prevention of anal cancers and precancerous lesions for Gardasil April 30, 2014 Sanofi Pasteur MSD announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Gardasil® to be used for the prevention of anal precancerous …

Dendreon Plans to Make PROVENGE Available in Europe

March 3, 2014 Dendreon Corporation today announced that it plans to make PROVENGE (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) available in Europe, beginning with Germany and the United Kingdom. Dendreon will make PROVENGE commercially available to patients within the approved label through Centers of Excellence using its Contract Manufacturing Organization, PharmaCell. Centers of Excellence are institutions where a high volume of prostate cancer …

If it’s Good Enough for the EU is it Good Enough for US? Bexsero in the USA

In the aftermath of the Meningitis B outbreaks at Princeton University and  the University of California, Santa Barbara, a debate has sparked over whether medicines with marketing approval on one side of the Atlantic should be automatically granted approval across the pond? When MenB broke out in Pinceton University late 2013 there was no vaccine available in the US which …

Download presentation: EMA regulatory activities in the area of vaccines: an update

In November 2012 over 200 delegates participated in the 13th Annual World Vaccine Congress Lyon in France. This event brings together vaccine leaders and policy makers from around the globe. Attendees at this highly successful event were fortunate enough to hear this exciting presentation delivered by Marco Cavaleri, Head of Anti infectives and Vaccines, ‘EMA regulatory activities in the area …