Traduction de «products and important regulatory approvals » (Néerlandais → Français) :

Second quarter Novartis delivered a strong performance in the second quarter of 2010 – with the rapid expansion of recently launched products and important regulatory approvals achieved for new medicines – as the Group made progress on its agenda on innovation, growth and productivity.
Deuxième trimestre Novartis a réalisé, au deuxième trimestre 2010, une croissance due à l’expansion rapide des produits lancés récemment et aux autorisations importantes obtenues pour de nouveaux médicaments, tandis que le Groupe a progressé dans la réalisation de son programme ciblé sur l'innovation, la croissance et la productivité.

First quarter Novartis delivered a strong performance in the first quarter of 2010 – particularly the rapid expansion of recently launched products and important regulatory approvals achieved for new medicines and vaccines – as the Group made progress with a sharp focus on innovation, growth and productivity.
Premier trimestre Novartis a réalisé, au premier trimestre 2010, une forte croissance – due en particulier à l’expansion rapide des produits lancés récemment et aux autorisations importantes obtenues pour de nouveaux vaccins et médicaments – car le Groupe a progressé en se concentrant sur l'innovation, la croissance et la productivité.

Other important regulatory approvals in 2009 were received for the H1N1 pandemic flu vaccines in the US and Europe as well as the first-ever biosimilar in Japan and Prevacid 24HR, the first and only OTC version of this proton pump inhibitor in the US.
D’autres homologations importantes ont été reçues en 2009 pour les vaccins contre la pandémie de grippe H1N1 aux Etats-Unis et en Europe ainsi que pour le premier biosimilaire jamais produit au Japon et Prevacid 24HR, la première et unique version en vente libre de cet inhibiteur de la pompe à protons, aux Etats-Unis.

European Union regulatory approval is anticipated soon, after the Committee for Medicinal Products (CHMP) issued a positive opinion in May supporting approval in renal cell carcinoma following progression on VEGF-targeted therapy.
Dans l’Union européenne, l’autorisation est attendue sous peu dès lors que le Committee for Medicinal Products (CHMP) a émis un avis favorable soutenant l’homologation dans le carcinome des cellules rénales à la suite de la progression du traitement ciblé sur le VEGF.

Among new product launches initiated in the 2009 quarter were Onbrez Breezhaler (COPD) in Germany following European regulatory approval in November.
Parmi les produits lancés au quatrième trimestre 2009 se trouve Onbrez Breezhaler (BPCO) en Allemagne à la suite de l'autorisation délivrée en novembre par l'Union européenne.

This release contains forward-looking information about an agreement by Pfizer to acquire FoldRx, and about FoldRx’s product candidate tafamidis, its other clinical and preclinical development programs and its technology platform, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments.

Recently launched products provided important contributions in Oncology (USD 2.5 billion, +14% lc), which benefited from the new anti-cancer medicine Afinitor (USD 32 million) approved in 2009 and new clinical data supporting Tasigna (USD 68 million, +101% lc).
Oncologie (USD 2,5 milliards, +14% en m. l) a profité d’importantes contributions des nouveaux produits, en particulier Afinitor (USD 32 millions), médicament anticancer homologué en 2009, et de nouveaux résultats cliniques supportant Tasigna (USD 68 millions, +101% en m. l.).