Vertaling van "receive a regulatory decision " (Nederlands → Frans) :

Afinitor (everolimus, RAD001), an oral inhibitor of the mTOR pathway, is currently expected to receive a regulatory decision for patients with advanced kidney cancer from the FDA in the first quarter of 2009 after the action date was extended by three months in late 2008 (no request for additional studies).
Afinitor (évérolimus, RAD001), inhibiteur par voie orale de la voie mTOR devrait être autorisé par la FDA au premier trimestre 2009 pour le traitement de patients atteints d’un cancer avancé du rein après que la décision a été repoussée de trois mois à fin 2008, sans que des études complémentaires aient été demandées.

These include a historic five regulatory approvals to date in Japan for Rasilez, Tasigna, Xolair, Co-Dio and Lucentis, with regulatory decisions pending for Exforge and Galvus in the world’s second-largest pharmaceuticals market.
Celles-ci comprennent cinq autorisations de mise sur le marché au Japon, qui est le deuxième des plus importants marchés pharmaceutiques du monde, pour Rasilez, Tasigna, Xolair, Co-Dio et Lucentis, tandis que deux sont en suspens pour Exforge and Galvus.

Exforge HCT, which includes the addition of a diuretic to this combination, received US regulatory approval in April 2009 as the only high blood pressure therapy with three medicines in one pill.
Exforge HCT, qui comprend l’adjonction d’un diurétique, a reçu en avril 2009 une autorisation au Etats-Unis en tant que seul traitement contre l’hypertension associant trois médicaments en un comprimé unique.

In August 2009, Xolair received European regulatory approval to treat children age six and older.
En août 2009, Xolair a été homologué en Europe pour le traitement des enfants à partir de six ans.

Glivec received European regulatory approval in May 2009 as a post-surgery (adjuvant setting) therapy for GIST following Swiss (February 2009) and US (December 2008) approvals.
Glivec a été homologué en mai 2009 par les autorités européennes comme traitement adjuvant postchirurgical contre les GIST, à la suite de la Suisse (février 2009) et des Etats-Unis (décembre 2008).

Ilaris (canakinumab, formerly ACZ885), a human antibody targeting IL-1 beta, received US regulatory approval in June as a new therapy to treat children as young as four years old and adults with CAPS (Cryopyrin-Associated Periodic Syndromes), a group of serious life-long auto-inflammatory diseases.
Ilaris (canakinumab, anciennement ACZ885), un anticorps humain ciblant IL-1 bêta, a été autorisé en juin aux Etats-Unis comme nouveau traitement chez les enfants de plus de quatre ans et les adultes atteints des syndromes périodiques associés à la cryopyrine (CAPS), un groupe de maladies auto-inflammatoires sévères durant toute la vie.

Coartem (artemether/lumefantrine), the leading artemisinin-based combination treatment for malaria, received US regulatory approval in April.
Coartem (artéméther/luméfantrine), traitement combiné de pointe à base d’artémisinine contre le paludisme, a été homologué en avril aux Etats-Unis.

Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13, including its potential benefits; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; 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.

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.