Vertaling van "regulatory approval this year " (Nederlands → Frans) :

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.

Omnitrope, the pioneering biosimilar of the recombinant human growth hormone somatropin, has received regulatory approval as the first-ever biosimilar in Japan under the brand name Somatropin BS S.C. This approval paves the way for greater access to high-quality biopharmaceuticals in the world’s second-largest pharmaceuticals market and comes about three months after Japanese authorities published guidelines for a biosimilar regulatory pathway, which is based on similar scientific principles already in place in the European Union.
Omnitrope, biosimilaire pionnier de la somatropine, une hormone de croissance humaine recombinante, a obtenu une autorisation au Japon sous la marque Somatropin BS S.C. Il s’agit du premier biosimilaire à avoir été homologué dans ce pays.

In February, this therapy for mild to moderate forms of Alzheimer’s disease dementia (approved in Europe) as well as dementia linked with Parkinson’s disease (approved in the US) was also submitted for regulatory approval in Japan.
Exelon/Exelon Patch est un traitement des formes légères à modérées de la maladie d'Alzheimer et de la démence associée à la maladie de Parkinson. La première indication a été autorisée en Europe et la seconde, aux Etats-Unis, tandis qu’une demande d’homologation a aussi été déposée en février au Japon.

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.

Exforge HCT, which adds a diuretic to this combination, was launched in the US after regulatory approval in April 2009 as a high blood pressure therapy with three medicines in one pill.
Exforge HCT, qui ajoute un diurétique à cette association, a été lancé aux Etats-Unis où il a été autorisé, en avril 2009, en tant que traitement contre l’hypertension associant trois médicaments en un comprimé unique.

As a result, Novartis will not seek regulatory approval for this indication.
Par conséquent, Novartis ne va pas chercher à obtenir son homologation pour cette indication.

Valturna – a single-pill combination of Tekturna/Rasilez and Diovan (valsartan) – gained US regulatory approval in September based on clinical data showing this medicine offers significantly higher blood pressure reduction than either valsartan or aliskiren alone.
Valturna, un comprimé associant Rasilez/Tekturna et Diovan (valsartan), a obtenu, en septembre, son autorisation de mise sur le marché aux Etats-Unis. Cette décision s'est appuyée sur des données cliniques montrant que ce médicament provoque une baisse nettement plus importante de la pression sanguine que valsartan ou aliskiren seuls.

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.