Vertaling van "new clinical data and regulatory " (Nederlands → Frans) :

Oncology Gleevec/Glivec (USD 2.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals.
Oncologie Glivec/Gleevec (USD 2,9 milliards, +12% en m. l.), traitement ciblé contre certaines formes de leucémie myéloïde chronique (LMC) et de tumeurs stromales gastrointestinales (GIST), a enregistré une croissance soutenue à deux chiffres, grâce à sa position de leader dans le traitement de ces cancers, étayée par de nouveaux résultats cliniques et par des autorisations de mise sur le marché.

Gleevec/Glivec (USD 1.9 billion, +15% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), has achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals.
Glivec/Gleevec (USD 1,9 milliard, +15% en m. l.), traitement ciblé contre certaines formes de leucémie myéloïde chronique (LMC) et les tumeurs stromales gastrointestinales (GIST), a enregistré une croissance à deux chiffres, grâce à sa position de leader dans le traitement de ces maladies, étayée par de nouveaux résultats cliniques et par des autorisations de mise sur le marché.

Gleevec/Glivec (USD 3.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals.
Glivec/Gleevec (USD 3,9 milliards, +12% en m. l.), traitement ciblé contre certaines formes de leucémie myéloïde chronique (LMC) et de tumeurs stromales gastro-intestinales (GIST), a enregistré une croissance soutenue à deux chiffres, grâce à sa position de leader dans le traitement de ces cancers, étayée par de nouveaux résultats cliniques et par des autorisations de mise sur le marché.

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.).

New clinical data has demonstrated the potential of Tasigna to become a leading therapy for newly diagnosed CML patients.
De nouvelles données cliniques ont démontré que Tasigna était susceptible de devenir un traitement de pointe pour les malades chez qui la LMC a été diagnostiquée depuis peu de temps.

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.

Menveo, which was submitted in 2008 for US regulatory approval as a new vaccine to protect against four common types of meningococcal meningitis in people age 11-55, has received a Complete Response letter from the FDA requesting additional information on the submission’s clinical and CMC (Chemistry Manufacturing and Control) sections.
Menveo, a été soumis en 2008 aux autorités sanitaires américaines en vue d’obtenir son autorisation en tant que vaccin contre quatre types communs de méningite à méningocoques chez les personnes âgées de 11 à 55 ans. Ce médicament a reçu de la FDA une «Complete Response letter» demandant des informations complémentaires sur les sections Clinique et CMC (Chemistry Manufacturing and Control) du dossier.

Novartis ranks as having one of the industry’s most competitive pharmaceuticals development pipelines with 147 projects in clinical development, of which 27 involve new molecular entities in late-stage trials or under regulatory review.
Novartis est considéré comme possédant l’un des pipelines de produits pharmaceutiques les plus concurrentiels de l’industrie avec 147 projets en développement clinique, dont 27 impliquent de nouvelles entités moléculaires qui sont en phase ultime d’essais ou en cours d’examen par les autorités réglementaires.