GSK and Theravance submit US sNDA for Breo Ellipta in asthma – The Pharma Letter


The Pharma Letter

GSK and Theravance submit US sNDA for Breo Ellipta in asthma
The Pharma Letter
Today's filing is based on data generated from the comprehensive clinical development program for FF/VI in asthma. The clinical development program comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients …
Glaxo, Theravance File Asthma Drug Application with FDANASDAQ
Glaxo submits new drug application for asthma treatmentIFA Magazine
GSK and Theravance Announce Submission to US Regulatory Authorities for MarketWatch
RTT News
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Glaxo set to submit Relovair to regulatory authorities – ShareCast

Glaxo set to submit Relovair to regulatory authorities
ShareCast
Additionally, all but one of the pivotal studies in patients with asthma have been completed. For COPD, Glaxo intends to submit regulatory applications in the US and Europe in mid-2012. For asthma, Glaxo plans to submit an application in Europe in
GSK and Theravance Announce Initial Outcomes From Pivotal Phase III Studies MarketWatch (press release)

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View full post on asthma – Google News