Vertaling van "regulatory decision for patients with advanced " (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.

Afinitor (USD 12 million), an oral inhibitor of the mTOR pathway, was launched in the US after regulatory approval was granted in March as the first therapy for patients with advanced renal cell carcinoma (kidney cancer) after failure of treatment with sunitinib or sorafenib.
Afinitor (USD 12 millions), inhibiteur par voie orale de la voie mTOR, a été lancé aux Etats-Unis après avoir reçu, en mars, son homologation en tant que traitement du carcinome avancé des cellules rénales (cancer du rein) après échec d’un traitement par sunitinib ou sorafenib.

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.

Afinitor (USD 67 million) continued regulatory submissions with a filing in the EU with the trade name Votubia for patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis.
Afinitor (USD 67 millions), les demandes d’autorisation se poursuivent, notamment dans l’UE sous la marque Votubia pour le traitement de l’astrocytome sous épendymaire à cellules géantes associé à une sclérose tubéreuse.

The optimal scenario for informing the patient with regard to decisions related to reimbursement of products linked to a specific treatment is similar to the previous one but (Figure 8) presents a higher number of respondents choosing “inside the organs” and “at each step”. Only 26% would choose to inform the patient outside the existing organs, and with a stronger preference on informing after the decision is taken.
The optimal scenario for informing the patient with regard to decisions related to reimbursement of products linked to a specific treatment is similar to the previous one but ( Figure 8) presents a higher number of respondents choosing “inside the organs” and “at each step”.

In een ‘Advance Decision’ wordt opgenomen wat de patiënt niet wil wat met hem gebeurt.
En cas d’‘Advance Decision’, on enregistre ce que le patient ne désire pas voir arriver.

Afinitor (USD 38 million), an oral inhibitor of the mTOR pathway, received European approval in August 2009 for use in patients with advanced renal cell carcinoma (RCC, kidney cancer) whose disease progressed on or after treatment with VEGF-targeted therapy.
Afinitor (USD 38 millions), inhibiteur par voie orale de la voie mTOR, a obtenu son autorisation dans l’Union européenne en tant que traitement du carcinome avancé des cellules rénales (cancer du rein) chez les malades où le carcinome a progressé pendant ou après un traitement ciblé sur le VEGF.

Extavia (USD 26 million), for patients with relapsing forms of multiple sclerosis (MS), was first launched in the European Union in early 2009 and is now available in more than 15 countries, including the US where it was launched recently after regulatory approval was granted in August 2009.
Extavia (USD 26 millions), pour les malades atteints de formes cycliques de sclérose en plaques (SEP), a été commercialisé d’abord dans l’Union européenne début 2009.

RADIANT 2, a placebo-controlled Phase III study of Afinitor in combination with Sandostatin LAR versus Sandostatin LAR alone in patients with advanced carcinoid tumors missed the primary endpoint by a very small statistical margin (progression-free survival Hazard Ratio = 0.77 in favor of Afinitor, p = 0.026 vs p=0.024 predefined).
RADIANT 2, une étude de phase III contrôlée par placebo d’Afinitor en association avec Sandostatine LAR comparé à Sandostatine LAR seul dans les tumeurs carcinoïdes avancées a raté son critère principal avec une marge statistique très petite ( survie sans progression de la maladie « hazard ratio » = 0,77 en faveur d’Afinitor, p = 0,026 contre p = 0,024 prédéfinie)..