Biotech Values

[DewDiligence]

From #msg-49185209:

Onbrez Breezhaler (QAB149)…a once-daily long-acting bronchodilator for adult patients with chronic obstructive pulmonary disease (COPD), was launched in Germany in December 2009 as well as Ireland and Denmark in March 2010 after European regulatory approval in November 2009. More than 20 launches are planned globally for the second half of 2010, including in the UK, Spain, Brazil and Mexico. Regulatory submissions are also planned for 2010 in Japan and China. In the US, all clinical studies to support resubmission have been started following a Complete Response letter from the FDA in October 2009 requesting additional data.