07:00 , Aug 8, 2011 |  BC Week In Review  |  Clinical News

Axanum low dose aspirin/esomeprazole magnesium regulatory update

AstraZeneca said 23 countries in the EU and Norway issued a positive agreement for approval of an MAA for Axanum aspirin/esomeprazole to prevent cardiovascular events in high risk cardiovascular patients requiring daily low-dose aspirin treatment...
07:00 , Aug 1, 2011 |  BC Week In Review  |  Clinical News

Axanum low dose aspirin/esomeprazole magnesium combination product regulatory update

AstraZeneca withdrew an NDA for Axanum aspirin/esomeprazole to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers for commercial reasons. FDA issued a complete response letter for the low dose aspirin/esomeprazole magnesium combination product...
00:17 , Jul 29, 2011 |  BC Extra  |  Financial News

AstraZeneca reports earnings

AstraZeneca plc (LSE:AZN; NYSE:AZN) reported 2Q11 core EPS of $1.73, missing by $0.07 the Street's estimate of $1.80 and down 5% based on constant exchange rates from $1.79 in 2Q10. However, the pharma raised its...
07:00 , Jun 7, 2010 |  BC Week In Review  |  Clinical News

Axanum aspirin/esomeprazole magnesium regulatory update

AstraZeneca submitted an MAA in Europe for Axanum aspirin/esomeprazole to prevent cardiovascular and cerebrovascular events in patients requiring continuous low-dose aspirin treatment who are at risk of developing aspirin-associated gastric and/or duodenal ulcers. The MAA...
07:00 , Jun 7, 2010 |  BC Week In Review  |  Clinical News

Axanum aspirin/esomeprazole magnesium regulatory update

FDA issued a complete response letter for an NDA for Axanum aspirin/esomeprazole to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers. AstraZeneca did not disclose details of the letter but said it is...
23:21 , Jun 4, 2010 |  BC Extra  |  Company News

AstraZeneca submits Axanum MAA

AstraZeneca plc (LSE:AZN; NYSE:AZN) submitted an MAA in Europe for Axanum aspirin/esomeprazole to prevent cardiovascular and cerebrovascular events in patients requiring continuous low-dose aspirin treatment who are at risk of developing aspirin-associated gastric and/or duodenal...
01:11 , Jun 2, 2010 |  BC Extra  |  Company News

Axanum receives complete response

FDA issued a complete response letter for an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for Axanum aspirin/esomeprazole to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers. The agency also issued a complete response...
07:00 , May 18, 2009 |  BC Week In Review  |  Clinical News

Low dose aspirin/esomeprazole magnesium combination product regulatory update

AstraZeneca submitted an NDA to FDA for its low dose aspirin/esomeprazole magnesium combination product to reduce the risk of low dose aspirin-associated gastric and/or duodenal ulcers. The company's Nexium esomeprazole, a proton pump inhibitor,...