Ipsen S.A. ADR (IPSEY) 14.9800 $IPSEY
Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
GlobeNewswire - Mon Oct 05, 6:30AM CDT
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the FDA has cleared the company's Investigational New Drug application (IND) for tinnitus product candidate OTO-311, a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist, gacyclidine. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.
OTIC: 19.15 (+0.39), IPN: 28.62 (unch)
Ipsen to release additional batch of Increlex in US commercially
M2 - Fri Oct 02, 4:35AM CDT
Ipsen SA (Paris: IPN.PA), a global specialty-driven biotechnological group, announced on Thursday that, in collaboration with the US FDA (Food and Drug Administration), an additional batch of Increlex will be available for commercial distribution starting in November 2015.
Stephane Bessette is appointed Executive Vice President, Human Resources of Ipsen
Business Wire - Thu Oct 01, 1:15AM CDT
Regulatory News:
Ipsen Announces Release of an Additional Batch of Increlex(R) in the U.S.
Business Wire - Thu Oct 01, 1:00AM CDT
Regulatory News:
Ipsen reports on transactions in own shares
M2 - Tue Sep 08, 4:15AM CDT
Ipsen SA (Paris:IPN.PA) on Monday reported that during the period 31 August 2015 to 4 September 2015, it purchased 20,000 of its own shares.
Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
GlobeNewswire - Mon Oct 05, 6:30AM CDT
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the FDA has cleared the company's Investigational New Drug application (IND) for tinnitus product candidate OTO-311, a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist, gacyclidine. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.
OTIC: 19.15 (+0.39), IPN: 28.62 (unch)
Ipsen to release additional batch of Increlex in US commercially
M2 - Fri Oct 02, 4:35AM CDT
Ipsen SA (Paris: IPN.PA), a global specialty-driven biotechnological group, announced on Thursday that, in collaboration with the US FDA (Food and Drug Administration), an additional batch of Increlex will be available for commercial distribution starting in November 2015.
Stephane Bessette is appointed Executive Vice President, Human Resources of Ipsen
Business Wire - Thu Oct 01, 1:15AM CDT
Regulatory News:
Ipsen Announces Release of an Additional Batch of Increlex(R) in the U.S.
Business Wire - Thu Oct 01, 1:00AM CDT
Regulatory News:
Ipsen reports on transactions in own shares
M2 - Tue Sep 08, 4:15AM CDT
Ipsen SA (Paris:IPN.PA) on Monday reported that during the period 31 August 2015 to 4 September 2015, it purchased 20,000 of its own shares.
