Traduction de «approval this year » (Néerlandais → Français) :

Results of a one-year study, which was undertaken in response to “approvable letters” from the FDA, achieved primary efficacy and renal function targets and were also consistent with experience seen in 70 countries – including in Europe – where this medicine has been approved.
Les résultats d’une étude d’un an, entreprise en réponse à des «approvable letters» émises par la FDA, a atteints ses objectifs principaux en termes d’efficacité et de fonction rénale. Ces résultats étaient également en adéquation avec les expériences récoltées dans 70 pays – notamment en Europe – où ce médicament est autorisé.

NPC has been cooperating with parallel civil and criminal investigations by the EDPA into allegations of potential off-label marketing and promotion of the epilepsy therapy Trileptal as well as certain payments made to healthcare providers in connection with this medicine. Earlier this year, NPC entered into a plea agreement with the EDPA, which is contingent on court approval, to resolve criminal allegations.
NPC coopère aux investigations civiles et criminelles que l’EDPA mène en parallèle au sujet d’accusations de promotion de Trileptal, un traitement contre l’épilepsie, pour des indications pour lesquelles ce produit n’a pas été autorisé, et de certains paiements à des prestataires de soins de santé en lien avec ce médicament.

This approval was based on data showing Xolair reduced asthma attacks in this age group by 34% at 24 weeks and 50% at one year.
Cette autorisation repose sur des résultats montrant que Xolair réduisait les accès d’asthme chez ce groupe d’âges de 34% sur 24 semaines et de 50% sur un an.

The formal EMA approval is expected by the end of this year.
L’autorisation formelle de l’EMEA est attendue pour la fin de cette année.

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.

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.

Reclast/Aclasta (USD 200 million, +105% lc), the first once-yearly infusion therapy for osteoporosis, has been fueled by increasing patient access to infusion centers in the US and Europe as well as a growing list of approved indications for use in a broad range of patients suffering from various types of this debilitating disease.
Aclasta/Reclast (USD 200 millions, +105% en m. l.), premier traitement de l’ostéoporose par perfusion annuelle, a bénéficié de l’accroissement du nombre de centres de perfusion facilitant l’accès aux malades aux Etats-Unis et en Europe ainsi que l’allongement de la liste des indications autorisées pour une utilisation chez de nombreux malades souffrant de différents types de cette maladie invalidante.