Ipsen S.A. ADR (IPSEY) 11.8500 $IPSEY
Ipsen Announces Acceptance of Filings for Somatuline(R) in the Treatment of GEP-NETs(1) in the US with Priority Review
Business Wire - Mon Sep 01, 9:07AM CDT
Ipsen N.A., an affiliate of Ipsen (Euronext:IPN; ADR:IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of its supplemental New Drug Application (sNDA) for Somatuline(R) Depot(R) 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early Q1, 2015.
Ipsen Announces Acceptance of Filings for Somatuline(R) in the Treatment of GEP-NET(1)s in the US with Priority Review and in Europe
Business Wire - Mon Sep 01, 12:00AM CDT
Regulatory News:
Ipsen: 2014 Half-Year Results and 2014 Objectives
Business Wire - Fri Aug 29, 12:00AM CDT
--Strong Somatuline(R) growth of 14.6%(1), up double-digit across all geographies(2)
Ipsen Announces Second Resupply of Increlex(R) (mecasermin [rDNA origin] Injection) in the U.S. in 2014
Business Wire - Tue Aug 26, 9:07AM CDT
--Ipsen continues to work with the FDA to release future batches of Increlex(R)
Ipsen Appoints Cynthia Schwalm as President and CEO of Ipsen North America
Business Wire - Wed Aug 20, 8:07AM CDT
Ipsen (Euronext:IPN; ADR:IPSEY) today announced that Cynthia Schwalm has been named President and CEO of Ipsen N.A., responsible for all commercial and medical affairs operations throughout the region. She will assume oversight of all areas supporting the North American Business and will report to Pierre Boulud, EVP of Specialty Care Commercial Operations.
New England Journal of Medicine publishes Ipsen's Somatuline(R) CLARINET(R) Phase III results in patients with metastatic gastroenteropancreatic neuroendocrine tumors
Business Wire - Thu Jul 17, 12:00AM CDT
--After 96 weeks of investigational treatment with Somatuline(R), the risk of disease progression or death was reduced by 53%
New England Journal of Medicine Publishes Ipsen's Somatuline(R) CLARINET(R) Phase III Results in Patients with Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Business Wire - Wed Jul 16, 4:29PM CDT
--After 96 weeks of investigational treatment with Somatuline(R), the risk of disease progression or death was reduced by 53%
Ipsen and Galderma become exclusive partners for development and marketing of neurotoxins in the US, Canada, Brazil and Europe(1)
Business Wire - Fri Jul 11, 12:00AM CDT
--Ipsen and Galderma to collaborate on development and commercialization of new neurotoxins, including their respective liquid formulations
Ipsen submits marketing authorization applications in the U.S. and Europe for Somatuline(R) (lanreotide) in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Business Wire - Tue Jul 01, 7:30AM CDT
--Marketing authorization variations submitted in 25 countries of the European Union
Ipsen's net profit up by 6.4% in H1 2013
M2 - Fri Aug 30, 7:59AM CDT
Ipsen SA (Euronext: IPN) (Paris: IPN.PA), a specialty-driven pharmaceutical company, on Friday reported consolidated net profit attributable to shareholders of EUR96.2m, or diluted EPS of EUR1.15, for the first half 2013, ended 30 June 2013.
Baxter closes deal for potential hemophilia drug
By The Associated Press - AP - Thu Mar 21, 8:39AM CDT
Baxter International Inc. has closed its acquisition of a potential hemophilia treatment from the French drugmaker Ipsen and Inspiration Biopharmaceuticals Inc. in a deal that could be worth more than $180 million.
Ipsen Announces Acceptance of Filings for Somatuline(R) in the Treatment of GEP-NETs(1) in the US with Priority Review
Business Wire - Mon Sep 01, 9:07AM CDT
Ipsen N.A., an affiliate of Ipsen (Euronext:IPN; ADR:IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of its supplemental New Drug Application (sNDA) for Somatuline(R) Depot(R) 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early Q1, 2015.
Ipsen Announces Acceptance of Filings for Somatuline(R) in the Treatment of GEP-NET(1)s in the US with Priority Review and in Europe
Business Wire - Mon Sep 01, 12:00AM CDT
Regulatory News:
Ipsen: 2014 Half-Year Results and 2014 Objectives
Business Wire - Fri Aug 29, 12:00AM CDT
--Strong Somatuline(R) growth of 14.6%(1), up double-digit across all geographies(2)
Ipsen Announces Second Resupply of Increlex(R) (mecasermin [rDNA origin] Injection) in the U.S. in 2014
Business Wire - Tue Aug 26, 9:07AM CDT
--Ipsen continues to work with the FDA to release future batches of Increlex(R)
Ipsen Appoints Cynthia Schwalm as President and CEO of Ipsen North America
Business Wire - Wed Aug 20, 8:07AM CDT
Ipsen (Euronext:IPN; ADR:IPSEY) today announced that Cynthia Schwalm has been named President and CEO of Ipsen N.A., responsible for all commercial and medical affairs operations throughout the region. She will assume oversight of all areas supporting the North American Business and will report to Pierre Boulud, EVP of Specialty Care Commercial Operations.
New England Journal of Medicine publishes Ipsen's Somatuline(R) CLARINET(R) Phase III results in patients with metastatic gastroenteropancreatic neuroendocrine tumors
Business Wire - Thu Jul 17, 12:00AM CDT
--After 96 weeks of investigational treatment with Somatuline(R), the risk of disease progression or death was reduced by 53%
New England Journal of Medicine Publishes Ipsen's Somatuline(R) CLARINET(R) Phase III Results in Patients with Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Business Wire - Wed Jul 16, 4:29PM CDT
--After 96 weeks of investigational treatment with Somatuline(R), the risk of disease progression or death was reduced by 53%
Ipsen and Galderma become exclusive partners for development and marketing of neurotoxins in the US, Canada, Brazil and Europe(1)
Business Wire - Fri Jul 11, 12:00AM CDT
--Ipsen and Galderma to collaborate on development and commercialization of new neurotoxins, including their respective liquid formulations
Ipsen submits marketing authorization applications in the U.S. and Europe for Somatuline(R) (lanreotide) in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Business Wire - Tue Jul 01, 7:30AM CDT
--Marketing authorization variations submitted in 25 countries of the European Union
Ipsen's net profit up by 6.4% in H1 2013
M2 - Fri Aug 30, 7:59AM CDT
Ipsen SA (Euronext: IPN) (Paris: IPN.PA), a specialty-driven pharmaceutical company, on Friday reported consolidated net profit attributable to shareholders of EUR96.2m, or diluted EPS of EUR1.15, for the first half 2013, ended 30 June 2013.
Baxter closes deal for potential hemophilia drug
By The Associated Press - AP - Thu Mar 21, 8:39AM CDT
Baxter International Inc. has closed its acquisition of a potential hemophilia treatment from the French drugmaker Ipsen and Inspiration Biopharmaceuticals Inc. in a deal that could be worth more than $180 million.
