Positive agreement received for approval of VIMOVO in Europe
AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets has cleared an important regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU). This follows all 22 Concerned Member States agreeing with the assessment of the Netherlands Health Authority (MEB), acting as the Reference Member State for the Decentralised Procedure (DCP).
Novartis announced an agreement with Synthetic Genomics Vaccines Inc. (SGVI) to apply "synthetic genomics" technologies to accelerate the production of the influenza seed strains required for vaccine manufacturing. The seed strain is the starter culture of a virus, and is the base from which larger quantities of the vaccine virus can be grown.
The highly distinguished Awards Committee of the Galien Foundation has honoured Bayer's Xarelto® (rivaroxaban) with the Prix Galien International 2010 in the category Best Pharmaceutical Agent. Xarelto had previously already been recognised with national Prix Galien awards in Belgium, France and Switzerland. The Prix Galien Award recognizes outstanding achievements in improving health through the development of innovative therapies, and is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.
Amgen (Nasdaq: AMGN) announced that results from several important studies from the Company's oncology portfolio will be presented at the 35th European Society for Medical Oncology (ESMO) Congress, Oct. 8-12, 2010, in Milan, Italy.
GlaxoSmithKline (GSK) confirmed that the European Commission (EC) has granted an amendment of their marketing authorisation for their anti-clotting agent (antithrombotic) Arixtra® (fondaparinux) in the European Union for a new therapeutic indication. Fondaparinux 1.5 and 2.5 mg is now indicated for thetreatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
Pfizer Inc. (NYSE: PFE) provided an update to its development pipeline, which includes 118 programs from Phase 1 through registration. The updated pipeline continues to reflect Pfizer's ongoing investment in high-priority disease areas with considerable unmet medical need.