Vertaling van "track with re-filing expected by year " (Nederlands → Frans) :

In the US, all clinical studies to support resubmission continue on track with re-filing expected by year end.
Aux Etats-Unis, toutes les études cliniques visant à soutenir le dépôt, prévu en fin d'année, d’une nouvelle demande sont en cours.

Onbrez Breezhaler has since been launched in Ireland and Denmark in March 2010 with additional launches expected this year in 20 markets, including the UK, Spain, Brazil and Mexico.
Depuis, Onbrez Breezhaler a été lancé en mars en Irlande et au Danemark et d’autres lancements sont prévus cette année dans vingt marchés, dont le Royaume-Uni, l’Espagne, le Brésil et le Mexique.

Regulatory filings are expected this year in pancreatic neuroendocrine tumors (pNET) following data showing Afinitor met the primary endpoint of progression-free survival in a Phase III study of pNET.
A la suite de résultats d’une étude de phase III consacrée aux tumeurs neuroendocrines du pancréas (pTNE) montrant qu’Afinitor satisfaisait au critère principal de survie sans progression de la maladie, des demandes d’autorisation devraient être déposées cette année.

Taxes The tax rate (taxes as a percentage of pre-tax income) for the first nine months and third quarter of 2009 was 15.2%, in line with full-year expectations, and higher than the 14.0% tax rate in both of the same periods in 2008.
Impôts Le taux d’imposition (impôts exprimés en pourcentage du résultat avant impôts) s’est situé à 15,2%, contre 14,0% dans les deux périodes comparables de 2008, mais il est conforme aux attentes concernant l’exercice entier.

Other single-pill combinations in development are a combination of aliskiren and amlodipine, currently under regulatory review in the US and Europe, and a triple-combination therapy with aliskiren, amlodipine and a diuretic, expected to be submitted for US regulatory approval this year.
D’autres médicaments combinés en un comprimé unique sont en développement, tels que aliskirène et amlodipine, actuellement en cours d’examen aux Etats-Unis et en Europe, et une trithérapie avec aliskirène, amlodipine et un diurétique qu’il est prévu de soumettre cette année pour homologation aux Etats-Unis.

MenB vaccine is on track to be filed in Europe by the end of 2010 and discussions regarding the phase III trial continue with the FDA.
Le vaccin MenB est en voie d’être soumis à homologation en Europe d’ici à la fin de l’année, tandis que les discussions concernant un essai de phase III se poursuivent avec la FDA aux Etats-Unis.

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.