Traduction de «regulatory and market conditions » (Néerlandais → Français) :

This release contains forward-looking information that involves substantial risks and uncertainties concerning the possibility of future dividend increases. Such risks and uncertainties include, among other things, the Company’s future financial performance as well as general economic, political, business, industry, regulatory and market conditions.
Such risks and uncertainties include, among other things, the Company’s future financial performance as well as general economic, political, business, industry, regulatory and market conditions.

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.

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.

Oriel’s previous shareholders are eligible to receive milestone payments, which are contingent upon the company achieving future development steps, regulatory approvals and market launches, and sales royalties.
Les actionnaires précédents d’Oriel sont susceptibles de recevoir des paiements supplémentaires liés au franchissement d’étapes de développement, d’autorisations réglementaires et de lancements sur les marchés, ainsi que des redevances sur les ventes.

Healthcare markets around the world are evolving rapidly, driven by factors such as intensifying cost-containment initiatives, a more challenging regulatory environment and the changing roles of physicians and payors.
Les marchés des soins de santé autour du monde évoluent rapidement, sous l’influence de facteurs tels que les mesures visant à maîtriser les coûts, un environnement réglementaire plus difficile et le changement des rôles assumés par les médecins et les payeurs.

Improved business conditions in key markets and productivity gains, particularly in Marketing & Sales and R&D, reduced the total cost base while supporting investments in emerging markets and new products.
Une amélioration de la situation commerciale dans des marchés-clés et des gains de productivité, en particulier dans Marketing et vente ainsi que dans la R&D, ont réduit la base de coûts totale tout en soutenant les investissements dans les marchés émergents et les nouveaux produits.

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.

Two clinical studies recently confirmed rapid and sustained improvement in vision with Lucentis in another debilitating eye condition, visual impairment due to diabetic macular edema (DME), currently under regulatory review in the EU.
Deux études cliniques récentes ont confirmé que Lucentis améliorait rapidement et durablement la vision dans une autre affection invalidante de l'œil due à l’œdème maculaire diabétique.

The transaction, which is expected to be completed in 2010 or early 2011, is subject to certain closing conditions, including receipt of government and regulatory approvals in China.
Cette transaction, qui devrait être terminée en 2010 ou début 2011, est soumise à certaines conditions, notamment son acceptation par le gouvernement et l’approbation des autorités réglementaires de Chine.